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Introduction: Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with prostate cancer (PCa). Moreover, PCa patients who receive the androgen deprivation therapy (ADT) are more likely to develop CRF. Baduanjin exercise has been shown to improve CRF in some cancers. However, such effects have not been verified in patients with PCa treated with the ADT. So, this study was designed as a randomised controlled trial (RCT) to explore the effects of Baduanjin exercise on CRF in PCa patients treated with the ADT., Methods and Analysis: This study will be a single-centre, assessor and statistician blinded, RCT consisting of a 12 week intervention and 12 week follow-up. Patients with PCa who meet the inclusion criteria will be recruited from Shanghai Hudong Hospital. Participants will be randomly assigned to Baduanjin exercise group (n=42) and the control group (n=42), performing 12 weeks of Baduanjin exercise or reeiving the standard care. The primary outcome will be the clinical effect of Baduanjin exercise on CRF in PCa patients, which will be measured using the Piper Fatigue Self-Assessment (PFS) scale, a multidimensional measure of CRF using three different dimensions: somatic, emotional and cognitive. The secondary outcome will be the clinical effect of the Baduanjin exercise on the patient's level of fatigue, sleep, depression and life quality at the time, which will be assessed by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P)., Ethics and Dissemination: This study has been approved by Shanghai Hudong Hospital Ethics Committee, Shanghai province (2022 SHHDKY08). The trial results will be submitted to conferences and peer-reviewed journals., Trail Registration Number: ChiCTR2300074293., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Post-COVID-19 condition (post COVID, also known as long COVID) is a global public health issue estimated to affect over 100 million people. Common symptoms include fatigue, dyspnoea and cognitive dysfunction ('brain fog'). Over time, these symptoms have an adverse effect on mental health, physical activity and quality of life (QoL). The condition requires innovative and feasible treatment approaches that can be effective and self-managed. Physical activity is essential for good health; however, aerobic exercise or weightlifting may not be suitable for post COVID patients who experience fatigue or breathlessness. The benefits of yoga include improved flexibility, mobility, body strength and balance. It is also shown to reduce symptoms of fatigue and improve breathing efficiency, mental health and QoL. This study protocol describes the rationale and methods for a randomised controlled trial (RCT) of a yoga-based intervention designed for adults with post COVID., Methods and Analysis: A two-group, parallel, RCT with blinded follow-up assessments. Participants will be randomised with a 1:1 allocation to either a 12-week yoga-based intervention or a 12-week health promotion (active comparison) intervention. In total, 88 participants aged 30-65 years will be recruited and randomised. The primary outcome is health-related QoL (36-item Short-Form). Secondary outcomes are dyspnoea, fatigue, sleep quality, cognitive functions, mental fatigue, depression, anxiety, physical activity, demographic data and physical health measures. Data will be analysed as intention-to-treat basis, using linear mixed modelling. All assessments are conducted at Karolinska Institutet in Stockholm, Sweden. The yoga-based intervention will take place at a yoga studio centrally located in Stockholm city., Ethics and Dissemination: The study is approved by the Swedish Ethical Review Authority, reference number 2023/06518-01. All participants must sign written informed consent before enrolment and are free to withdraw from the study at any point. Key results will be available through research articles and seminars., Trial Registration Number: German Clinical Trials Register, DRKS00032837., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To critically evaluate the effectiveness of physical therapy interventions in improving global function, quality of life and fatigue in individuals with amyotrophic lateral sclerosis (ALS)., Design: Systematic review and meta-analyses., Data Sources: MEDLINE, EMBASE, Cochrane Library (CENTRAL) and Physiotherapy Evidence Database (PEDro) were searched through 31 January 2023., Eligibility Criteria: We included randomised clinical trials (RCTs) that compared physical therapy interventions that act on global function, fatigue and quality of life in individuals with ALS with any other non-physiotherapeutic methods and techniques, placebo or non-intervention. The primary outcome measure was the evaluation of global function. Secondary outcomes were quality of life, fatigue and adverse events., Data Extraction and Synthesis: Two independent authors used a researcher-developed extraction form and the Rayyan software to search, screen and code included studies. The risk of bias was assessed using the PEDro scale. Meta-analyses were conducted employing random effects. Outcomes were succinctly presented in Grading of Recommendations, Assessment, Development and Evaluation evidence profiles., Results: Our searches identified 39 415 references. After study selection, three studies were included in the review. Such studies involved 62 participants with a mean age of 54.6 years. In the evaluated trials, 40 were male, while 22 participants were female. Regarding the type of onset of the disease, 58 participants had spinal onset of ALS, and four had bulbar., Conclusions: Physical therapy intervention may improve the global function of individuals with ALS in the short term; however, clinically, it was inconclusive. In terms of quality of life and fatigue, physical therapy intervention is not more effective than control in the short term. Adverse events are not increased by physical therapy intervention in the short term. Due to significant methodological flaws, small sample sizes, wide CIs and clinical interpretation, our confidence in the effect estimate is limited., Prospero Registration Number: CRD42021251350., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing associated comorbidities that may influence fatigue is also poorly understood. This study represents the first investigation to use acupuncture as an intervention for fatigue in breast cancer survivors within a Norwegian cohort. The study will employ questionnaires to evaluate various facets of fatigue. As a pragmatic trial, it statistically assesses its clinical relevance, documents adverse events and evaluates the cost-effectiveness of the acupuncture treatment., Methods and Analysis: This assessor-blinded, pragmatic, randomised, mixed method, controlled trial with two parallel arms aims to evaluate the effectiveness, safety and cost-effectiveness of acupuncture. It will recruit 250 participants presented with CRF for 6 months or longer. Patients will be randomly allocated either to acupuncture and usual care (n=125) or to usual care alone (n=125). Acupuncture treatments (12 in total) are to be given within 12 weeks. The statistician who will analyse the data will be blinded to group allocation. The primary outcome will be changes in CRF measured by the Chalder fatigue scale. Measurements will be taken 12 weeks and 6 months after randomisation. The secondary outcomes include patient-reported outcomes of pain, anxiety, depression, hot flashes, insomnia and sleepiness. Health-related quality of life and economic evaluation will also be conducted 12 weeks and 6 months after randomisation. Nested within this randomised controlled trial are two qualitative studies and one sub-study measuring biomarkers (C-reactive protein, interleukin (IL)-1, IL-6, tumour necrosis factor alpha (TNF-α) and aPL in addition to the current genotype genes TNF-308 and IL-6-174) from blood samples (n=80). Such biomarkers can potentially address changes in CRF., Ethics and Dissemination: Ethical approval of this study has been granted by the Regional Committees for Medical and Health Research Ethics (REC southeast ID number: 112285). Written informed consent will be obtained from all participants. The outcomes of the trial will be disseminated through peer-reviewed publications., Trial Registration Number: NCT04418115., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related fatigue is common in patients with advanced lung cancer. It not only interferes with patients' health-related quality of life, but also increases the caregiving burden of their caregivers. Acceptance and commitment therapy is emerging as a novel way to advocate accepting negative experiences and taking effective actions based on their own values to help patients commit meaningful actions in the course of cancer diseases. This trial aims to test the feasibility, acceptability and preliminary effects of acceptance and commitment therapy for fatigue interference in patients with advanced lung cancer and the caregiver burden., Method and Analysis: A two-arm, assessor-blind pilot randomised controlled trial will be conducted. A total of 40 advanced lung cancer patient-caregiver dyads, who live in rural areas, will be recruited from a university-affiliated hospital in central China. The participants will be randomised to receive an online six-session acceptance and commitment therapy (i.e. involving metaphors, experiential exercises and mindfulness exercises facilitated by virtual reality technology) plus health education (intervention group, n=20) or health education (control group, n=20). Outcomes will be measured at baseline and 1 week postintervention. The primary outcomes are study feasibility (i.e. eligibility rate, recruitment rate, attrition rate and adherence rate), fatigue interference and caregiver burden. The secondary outcomes are health-related quality of life, meaning in life, psychological flexibility and mindful attention. Semistructured interviews will be conducted to explore the feasibility and experiences of the intervention in a subsample of 10 participants from the intervention group., Ethics and Dissemination: This study has been approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2023.030) and the Medical Ethics Committee of Xiangya Hospital Central South University (No. 202305336). The findings will be disseminated in peer-reviewed journals and through local or international conference presentations., Trial Registration Number: NCT05885984., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To explore the experiences and acceptability of music-cued motor imagery (MCMI), music-cued gait training (MCGT), and combined MCMI and MCGT (MCMI-MCGT) in people with multiple sclerosis (pwMS). We also aimed to explore participants' self-rated health status postintervention and gather recommendations for further programme development., Design: Qualitative study alongside the double-blind randomised controlled real and imagined gait training with music-cueing (RIGMUC) multicentre trial of MCMI, MCGT and MCMI-MCGT., Setting: PwMS recruited for the RIGMUC trial from Departments of Neurology at Medical Universities of Innsbruck and Graz and Clinic for Rehabilitation Muenster, Austria., Participants: All 132 pwMS with mild to moderate disability randomised into the trial were included in the analysis., Methods: Participants practised home-based MCMI, MCGT or MCMI-MCGT for 30 min, 4×/week, for 4 weeks. Three trained researchers conducted weekly semistructured telephone interviews during the intervention period, supporting adherence, addressing problems, sharing experiences and assessing intervention acceptability. Follow-up interviews at 4-week postintervention aimed to understand participants' self-rated changes in walking, fatigue and overall health compared with their prestudy condition. Investigator triangulation was employed among the researchers to enhance trustworthiness and credibility., Results: Using thematic analysis, we identified five themes: (1) empowerment, (2) remaining in sync, (3) interconnection between imagined and actual walking, (4) sustaining focus and (5) real-world transfer. Participants appreciated and found the imagined and actual MCGT innovative. Problems included concentration issues, early fatigue in advanced disability and difficulty synchronising with music cues. Positive changes in walking, fatigue and overall health postinterventions were reported offering valuable insights for programme development., Conclusions: A participatory study to codevelop a music-cued exercise programme for pwMS seems appropriate as participants appreciated the innovation and effectiveness of both imagined and actual MCGT. Future studies should also investigate pwMS' potential and limitations in enhancing their MCMI abilities with intensive therapist-supported practice., Trial Registration Number: DRKS00023978., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan., Methods and Analysis: This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge., Ethics and Dissemination: Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations., Competing Interests: Competing interests: PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this project. There are no competing interests in this project., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS., Methods and Analysis: The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5-4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12-18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted., Ethics and Dissemination: The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences., Trial Registration Number: EudraCT 2021-004868-95; NCT05809414., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is the most prevalent symptom for patients with a primary brain tumour (PBT), significantly reducing quality of life and limiting daily activities. Currently, there are limited options for managing cancer-related fatigue (CRF) in patients with a PBT, using non-pharmacological methods. The objective of this scoping review is to identify current and emerging evidence in relation to non-pharmacological CRF interventions for patients with a PBT., Methods and Analysis: Electronic databases OVID and EBSCO platforms: MEDLINE, EMBASE and CINAHL will be searched. In addition, PROSPERO, The Cochrane Library and ISI Web of Science will be searched. Trials registries CENTRAL and the International Clinical Trials Registry platform will also be searched for ongoing research., Inclusion Criteria: studies from 2006 onwards, primary research on non-pharmacological interventions in patients with a PBT (>18 years). A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram will be utilised to summarise the screening process and results.Quantitative data will be analysed descriptively, while content analysis will be used for qualitative data.Findings will map the existing and emerging evidence on non-pharmacological interventions for CRF in patients with PBTs. This will provide insights into the extent and nature of the evidence in this evolving field, identifying gaps in knowledge and research priorities, and guide further investigations in this area., Ethics and Dissemination: Ethical approval is not required for this scoping review. Findings will be disseminated via relevant peer-reviewed journals, PhD thesis, conference presentations, and shared with relevant charities and health professionals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fibromyalgia syndrome (FMS) is defined as a medical condition with chronic widespread musculoskeletal pain accompanied by mood disorders, fatigue and sleep disturbances. Treatment of this condition can often be challenging. As nutrition in general and nutritional interventions in the context of illness management become more and more important, current research also focuses on the relevance of diets for FMS, including gluten as field of interest. To date, there is no clear evidence that a gluten-free diet or other nutritional interventions are significantly important for the reduction of pain in the context of FMS. Only a very few studies show that FMS patients respond to a gluten-free diet and that cytokine production (also in FMS) can be reduced through the change. However, these studies have not investigated whether and to what extent cognitive factors, such as the expectation of symptom reduction triggered by diet, play a role. Recent research shows that treatment expectation plays an important role in the course of the disease and in the effectiveness of treatment approaches. For example, there are promising pain treatment options using open-label placebos (OLPs), which show that expectation alone, rather than the pharmacological substance of medication, can reduce pain experience. In our study protocol, we hypothesise that treatment expectation can be positively influenced by the given information regarding the placebos, resulting in improved treatment outcomes for pain and indigestions., Methods and Analysis: In this trial, patients with FMS will undergo a food challenge and take an OLP (patients will be informed about the placebo), followed by a 3-week OLP treatment. The subjects will be randomised into four groups: (a) gluten-free porridge+neutral OLP instructions; (b) gluten-free porridge+positive OLP instructions; (c) gluten-containing porridge+neutral OLP instructions and (d) gluten-containing porridge+positive OLP instructions. Patients will be recruited via different institutions and support groups in Hamburg. The inclusion criteria are (a) diagnosed FMS, (b) absence of wheat allergy, coeliac disease or pain-related red flags and (c) being a minimum age of 18 years. The study requires 100 subjects to assess the primary outcomes: pain intensity and occurence of indigestion. Secondary outcomes are functional capacity, treatment expectation, and different pain-related and inflammation-related blood parameters. The measure time points will be before and after the food challenge and before and after the 3-week OLP treatment., Ethics and Dissemination: Ethical approval was obtained in October 2021 from the Hamburg Medical Ethics Council. The results of the study will be disseminated through publications, presentations and conference meetings., Trial Registration Number: German Clinical Trials Register (DRKS; DRKS00027130)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related fatigue (CRF) is one of the most common and debilitating side effects experienced by patients with breast cancer (BC) during postoperative chemotherapy. Family-involvement combined aerobic and resistance exercise has been introduced as a promising non-pharmacological intervention for CRF symptom relief and improving patients' muscle strength, exercise completion, family intimacy and adaptability and quality of life. However, evidence for the practice of home participation in combined aerobic and resistance exercise for the management of CRF in patients with BC is lacking., Methods and Analysis: We present a protocol for a quasi-randomised controlled trial involving an 8-week intervention. Seventy patients with BC will be recruited from a tertiary care centre in China. Participants from the first oncology department will be assigned to the family-involvement combined aerobic and resistance exercise group (n=28), while participants from the second oncology department will be assigned to the control group that will receive standard exercise guidance (n=28). The primary outcome will be the Piper Fatigue Scale-Revised (R-PFS) score. The secondary outcomes will include muscle strength, exercise completion, family intimacy and adaptability and quality of life, which will be evaluated by the stand-up and sit-down chair test, grip test, exercise completion rate, Family Adaptability and Cohesion Scale, Second Edition-Chinese Version (FACESⅡ-CV) and Functional Assessment of Cancer Therapy -Breast (FACT-B) scale. Analysis of covariance will be applied for comparisons between groups, and paired t-tests will be used for comparison of data before and after exercise within a group., Ethics and Dissemination: This study has been approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (PJ-KS-KY-2021-288). The results of this study will be published via peer-reviewed publications and presentations at conferences., Trail Registration Number: ChiCTR2200055793., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: To investigate the efficacy and safety of hyperbaric oxygen therapy (HBOT) for fibromyalgia (FM)., Design: A systematic review and meta-analysis., Data Sources: PubMed, EMBASE, Cochrane Library, Web of Science, VIP (China Science and Technology Journal Database), CNKI (China National Knowledge Infrastructure) and WanFang database were searched from from inception to 22 October 2022., Eligibility Criteria: We included clinical trials (randomised controlled and non-randomised controlled trials) of HBOT for FM., Data Extraction and Synthesis: Two researchers independently screened the literature, extracted data and evaluated the quality of the included studies, with disagreements resolved by a third researcher. The Cochrane Collaboration checklists and the Methodological Index for Non-randomised Studies were used to assess the risk of bias. Meta-analysis was performed by RevMan V.5.4.1 software. Random effect models were used for meta-analysis., Results: Nine studies were included in this review, with a total of 288 patients. For pain assessment, we combined the results of the Visual Analogue Scale and Widespread Pain Index. The results showed that HBOT could relieve the pain of FM patients compared with the control intervention (standardised mean difference=-1.56, 95% CI (-2.18 to -0.93), p <0.001, I 2 =51%). Most included studies reported that HBOT ameliorated tender points, fatigue, multidimensional function, patient global and sleep disturbance in FM. Adverse events occurred in 44 of 185 patients (23.8%). Twelve patients (6.5%) withdrew because of adverse reactions. No serious adverse events or complications were observed., Conclusions: HBOT might have a positive effect in improving pain, tender points, fatigue, multidimensional function, patient global and sleep disturbance in FM, with reversible side effects. Low pressure (less than 2.0 atmospheric absolute) may be beneficial to reduce adverse events in FM. Further studies should be carried out to evaluate the optimal protocol of HBOT in FM., Prospero Registration Number: CRD42021282920., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Cognitive training is a non-drug intervention to improve the cognitive function of participants by training them in different cognitive domains. We investigated the effectiveness of cognitive training for patients with breast cancer reporting cognitive changes., Design: Systematic review and meta-analysis., Data Sources: PubMed, Embase, Cochrane Library, WOS, CINAHL, CNKI, VIP, SinoMed, Wanfang, Grey literature and trial registries were searched (from inception to 1 October 1, 2022)., Eligibility Criteria: Inclusion of randomized controlled trials (RCTs) assessing the effects of cognitive training on breast cancer patients reporting cognitive changes The primary outcome was subjective cognitive function. Secondary outcomes were objective cognitive functioning (eg, executive functioning and attention) and psychological outcomes(eg, anxiety, depression, and fatigue)., Data Extraction and Synthesis: Two reviewers worked independently to screen the literature, extract data, and assess the methodological quality and risk bias of the included studies. Results are reported as standardizedstandardised mean differences (SMDs) with 95% confidence intervals(CI). Grades of Recommendation, Assessment, Development, and Evaluation(GRADE) were used to assess the quality of evidence., Main Outcomes and Measures: The primary outcome was subjective cognitive function. Secondary outcomes were objective cognitive functioning (eg, executive functioning and attention) and psychological outcomes(eg, anxiety, depression and fatigue)., Results: A total of 9 RCTs involving 666 patients with breast cancer were included. The frequency of cognitive training varied and the duration was mostly focused on 5-12 weeks. It can be delivered to patients in an individual or group mode, both online and face to face. Meta-analysis revealed that cognitive training aimed at adaptive training in cognitive field has statistically significant effects on improving subjective cognitive function (SMD=0.30, 95% CI (0.08 to 0.51), moderate certainty). Some objective cognitive functions such as processing speed (SMD=0.28, 95% CI (0.02 to 0.54), low certainty), verbal memory (SMD=0.32, 95% CI (0.05 to 0.58), moderate certainty), working memory (SMD=0.39, 95% CI (0.17 to 0.61), moderate certainty) and episodic memory (SMD=0.40, 95% CI (0.11 to 0.69), moderate certainty) were significantly improved after the intervention. In addition, we did not find statistically significant changes in attention, short-term memory, execution function, depression, anxiety and fatigue in patients with breast cancer after the intervention. Subgroup analyses revealed that based on the delivery of individual sessions, the use of web-based cognitive training software may be more beneficial in improving the outcome of the intervention., Conclusion: Evidence of low to moderate certainty suggests that cognitive training may improve subjective cognition, processing speed, verbal memory, working memory and episodic memory in patients with breast cancer reporting cognitive changes. But it did not improve patients' attention, short-term memory, executive function, depression, anxiety and fatigue., Prospero Registration Number: CRD42021264316., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patients with advanced cancer often experience high levels of debilitating pain and pain-related psychological distress. Although there is increasing evidence that non-pharmacological interventions are needed to manage their pain, pharmacologic modalities remain the preferred treatment . Guided imagery is a form of focused relaxation that helps create harmony between the mind and body and has been shown to significantly improve cancer pain. Our study presents Virtual Reality Assisted Guided Imagery (VRAGI) as a complementary treatment modality to manage chronic pain in patients with cancer. We will conduct a randomised controlled trial to test its impact on patients with advanced cancer in a home setting., Methods and Analysis: We will recruit 80 patients from Prisma Health, a tertiary-level healthcare centre based in Greenville, South Carolina, USA. The prospective 2×2 randomised controlled trial will randomise participants into four groups: (1) VRAGI, (2) laptop-assisted guided imagery, (3) VR (no guided imagery) and (4) laptop (no guided imagery). Patients allocated to VR groups will be trained to use a head-mounted display that immerses them in 3D audio-video content. The non-VR group will use a laptop displaying 2D video content. We will collect measures before and during the 3-week intervention as well as 3 weeks after the intervention ends. Measures will include patient-reported outcomes of pain, anxiety, depression and fatigue in addition to opioid use. The primary objective of the current study is to assess the efficacy of VRAGI on pain in the home setting. The secondary objective is to assess the efficacy of VRAGI on opioid use, anxiety, depression and fatigue., Ethics and Dissemination: This study was approved by the Prisma Health Institutional Review Board (#Pro00114598) in November 2021. All participants enrolled in the study will provide written informed consent. Dissemination will be through peer-reviewed publications and conference presentations., Trial Registration Number: NCT05348174, clinicaltrials.gov., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is one of the most commonly recorded patient symptoms that can result in deficits in aspects of psychomotor functioning, cognition, work performance and mood. Research shows that bright light and dim light therapy may be an efficacious way to reduce symptoms of fatigue. Still, the feasibility, scalability, individual treatment effects and adverse event heterogeneity of these treatments are unknown., Methods and Analysis: The current study evaluates the feasibility, acceptability and effectiveness of a series of personalised (N-of-1) interventions for virtual delivery of bright light therapy and dim light therapy versus usual care treatment for fatigue in 60 participants. We hypothesise that this study will provide valuable information about implementing virtual, N-of-1 randomised controlled trials (RCTs) for fatigue. It will also offer results about determining participants' ratings of usability and satisfaction with the virtual, personalised intervention delivery system; evaluating participants' improvement of fatigue symptoms; and, in the long term, identify ways to integrate N-of-1 light therapy trials into patient care., Ethics and Dissemination: This trial was approved by the Northwell Health Institutional Review Board. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalised trials will follow the Consolidated Standards of Reporting Trials extension for N-of-1 trials CENT 2015 reporting guidelines., Registration Details: This trial is registered in www., Clinicaltrials: gov (number NCT04707846)., Trial Registration Number: NCT04707846., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease. SLE is treated with immunosuppressants with suboptimal efficacy and high risk of serious side effects. Patients with SLE have increased risk of mortality, organ damage and debilitating treatment-resistant fatigue. Autonomic nervous system dysfunction (AD) is present in approximately half of the patients and may promote autoimmunity by weakening the vagally mediated anti-inflammatory reflex. Recent studies suggest that transcutaneous vagus nerve stimulation (tVNS) has few side effects and beneficial effects on fatigue, pain, disease activity and organ function. This study investigates whether adjuvant tVNS improves measures of fatigue (primary end point), AD, clinical disease activity, inflammation, pain, organ function and quality of life.Hence, this study will contribute to the understanding of AD as a potentially important precursor of fatigue, disease activity, progression and complications in SLE, and how tVNS mechanistically may attenuate this. As adjuvant tVNS use may reduce the need for traditional immunosuppressive therapy, this trial may prompt a shift in the treatment of SLE and potentially other autoimmune disorders., Methods and Analysis: Eighty-four patients with SLE with fatigue and AD will be randomised 1:1 to active or sham tVNS in this double-blinded parallel-group study. In period 1 (1 week), participants will receive a 4 min tVNS 4 times daily and report on fatigue daily. After a 2-week pause, period 2 (8 weeks) will entail tVNS twice daily and participants will report on fatigue, pain and disease activity weekly. Secondary end points will be assessed before and after each period and after 1 week in period 2., Ethics and Dissemination: The study is approved by the Danish Medical Research Ethical Committees (case no: 2120231) and results will be published in international peer-reviewed journals., Trial Registration Number: NCT05315739., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related fatigue (CRF) is one of the most common and debilitating adverse effects of cancer and its treatment reported by cancer survivors. Physical activity, psychological interventions and management of concurrent symptoms have been shown to be effective in alleviating CRF. This pilot randomised controlled trial (RCT) will determine the feasibility of a telehealth CRF clinic intervention (T-CRF) to implement evidence-based strategies and assess the impact of the intervention on CRF and other clinical factors in comparison to usual care., Methods and Analysis: A parallel-arm (intervention vs usual care) pilot RCT will be conducted at the Princess Alexandra Hospital in Queensland, Australia. Sixty cancer survivors aged 18 years and over, who report moderate or severe fatigue on the Brief Fatigue Inventory and meet other study criteria will be recruited. Participants will be randomised (1:1) to receive the T-CRF intervention or usual care (ie, specialist-led care, with a fatigue information booklet). The intervention is a 24-week programme of three telehealth nurse-led consultations and a personalised CRF management plan. The primary objective of this pilot RCT is to determine intervention feasibility, with a secondary objective to determine preliminary clinical efficacy. Feasibility outcomes include the identification of recruitment methods; recruitment rate and uptake; attrition; adherence; fidelity; apathy; and intervention functionality, acceptability and satisfaction. Clinical and resource use outcomes include cancer survivor fatigue, symptom burden, level of physical activity, productivity loss, hospital resource utilisation and carer's fatigue and productivity loss. Descriptive statistics will be used to report on feasibility and process-related elements additional to clinical and resource outcomes., Ethics and Dissemination: This trial is prospectively registered (ACTRN12620001334998). The study protocol has been approved by the Metro South Health and Hospital Services Human Research Ethics Committee (MSHHS HREC/2020/QMS/63495). Findings will be disseminated through peer-reviewed publications, national and international conferences and seminars or workshops., Trial Registration Number: Australian New Zealand Clinical Trials Registry ID: ACTRN12620001334998; Pre-results. Trial Version: Version 1.1. Last updated 10 December 2020., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To determine the effectiveness of virtual reality (VR)-based intervention on the symptoms and rehabilitation management in patients with breast cancer., Design: Systematic review and meta-analysis., Study Selection: We included all eligible randomised controlled trials and quasi-experimental studies (published in English and Chinese)., Participants: Patients with breast cancer (≥18 years) undergoing cancer treatment., Interventions: Any intervention administered to improve the symptoms and rehabilitation of patients with breast cancer. The control group was given conventional care., Outcomes: All outcomes were as follows: pain, fatigue, anxiety, depressive symptoms, cognitive function, and range of motion of upper limb in patients with breast cancer., Data Sources: We searched PubMed, Embase, CENTRAL and SinoMed, four electronic databases, covering the database establishment period to January 2022., Review Methods: Two reviewers independently extracted content and data consistent with the prespecified framework and assessed risk bias. Random-effects meta-analysis was used to pool data across trials. Meta-analysis was performed using Review Manager V.5.4., Results: A total of eight studies met the eligibility criteria and were included in this study. The combined effect size showed that VR was positive for improving patients' anxiety(standard mean differenc (SMD)=-2.07, 95% CI= (-3.81 to -0.34), I 2 =95%) and abduction of upper limbs (MD=15.54, 95% CI= (12.79 to 18.29), I 2 =0%), but fatigue (SMD=-0.92, 95% CI= (-4.47 to 2.62), I 2 =99%) was not. Qualitative analysis showed VR improved patients' depressive symptoms, pain and cognitive function., Conclusions: VR technology has a good effect on symptoms and rehabilitation management of patients with breast cancer, but the quality of evidence is low, and the sample size is small. To date, there are few intervention studies, therefore, giving precise recommendation or conclusion is difficult. We have a favourable view of this, and more clinical studies are needed in the future to improve the credibility of the results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Multiple symptoms occur in people with kidney failure receiving haemodialysis (HD) and these symptoms have a negative impact on health-related quality of life (HRQoL). Fatigue, the most common symptom, is debilitating and difficult to manage. Educational interventions involving energy conservation strategies are helpful in reducing fatigue, however the effectiveness of energy conservation has not been previously studied in those receiving HD. The aim of this study is to evaluate the effectiveness of an energy conservation education intervention for people with end-stage kidney disease receiving HD (EVEREST trial)., Methods and Analysis: A pragmatic cluster randomised control trial with repeated measure will be used. One hundred and twenty-six participants from tertiary level dialysis centre will be cluster randomised to the intervention and control group according to HD treatment day. The intervention group will receive usual care along with a structured energy conservation education programme over 12 weeks comprising three individual face-to-face educational intervention sessions, one booster session and a booklet. The control group will receive usual care from their healthcare providers and a booklet at the end of the study. The primary outcome is fatigue, and the secondary outcomes are other Chronic Kidney Disease (CKD) symptoms, occupational performance and HRQoL. Intention-to-treat analysis will occur and will include a change in primary and secondary outcomes., Ethics and Dissemination: Ethical approval has been obtained from the Human Research Committee of the Griffith University and Nepal Health Research Council. The results of this research will be published and presented in a variety of forums., Trial Registration Number: NCT04360408., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Identifying interventions to reduce fatigue and improve life participation are top research priorities of people on maintenance haemodialysis., Objective: Our primary objective was to explore the feasibility of conducting a randomised controlled trial of an energy management programme for people on maintenance haemodialysis., Design: Parallel-arm, 1:1, blinded, pilot randomised controlled trial., Participants: Participants were recruited from 6 dialysis units in Calgary, Canada. Eligible patients were on maintenance haemodialysis, clinically stable and reported disabling fatigue on the Fatigue Severity Scale items 5, 7, 8 and 9., Randomisation: Participants were randomised using a computer-generated random number sequence according to permuted blocked randomisation, stratified by dialysis unit., Blinding: Participants were blinded to treatment allocation., Interventions: Participants received an attention control (general disease self-management education) or the Personal Energy Planning (PEP) programme, a tailored, web-supported 7-9 weeks energy management programme., Outcomes: Eligibility, recruitment and attrition rates were recorded, and standardised intervention effects (Hedge's G) were calculated for fatigue and life participation questionnaires at one1-week postintervention and 12-week postintervention., Results: 159 of 253 screened patients were eligible to be approached. 42 (26%) had fatigue, were interested and consented to participate, of whom 30 met eligibility criteria and were randomised (mean age 62.4 years (±14.7), 60% male). 22 enrolled participants (73%) completed all study procedures. Medium-sized intervention effects were observed on the Canadian Occupational Performance Measure (COPM)-Performance Scale, Global Life Participation Scale and Global Life Participation Satisfaction Scale at 1-week postintervention follow-up, compared with control. At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively., Conclusion: It is feasible to enrol and follow patients on haemodialysis in a randomised controlled trial of an energy management intervention. As the intervention was associated with improved life participation on some measures, a larger trial is justified., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Motor imagery (MI) refers to the mental rehearsal of a physical action without muscular activity. Our previous studies showed that MI combined with rhythmic-auditory cues improved walking, fatigue and quality of life (QoL) in people with multiple sclerosis (pwMS). Largest improvements were seen after music and verbally cued MI. It is unclear whether actual cued gait training achieves similar effects on walking as cued MI in pwMS. Furthermore, in pwMS it is unknown whether any of these interventions leads to changes in brain activation. The purpose of this study is therefore to compare the effects of imagined and actual cued gait training and a combination thereof on walking, brain activation patterns, fatigue, cognitive and emotional functioning in pwMS., Methods and Analysis: A prospective double-blind randomised parallel multicentre trial will be conducted in 132 pwMS with mild to moderate disability. Randomised into three groups, participants will receive music, metronome and verbal cueing, plus MI of walking (1), MI combined with actual gait training (2) or actual gait training (3) for 30 min, 4× per week for 4 weeks. Supported by weekly phone calls, participants will practise at home, guided by recorded instructions. Primary endpoints will be walking speed (Timed 25-Foot Walk) and distance (2 min Walk Test). Secondary endpoints will be brain activation patterns, fatigue, QoL, MI ability, anxiety, depression, cognitive functioning, music-induced motivation-to-move, pleasure, arousal and self-efficacy. Data will be collected at baseline, postintervention and 3-month follow-up. MRI reference values will be generated using 15 matched healthy controls., Ethics and Dissemination: This study follows the Standard Protocol Items: Recommendations for Interventional Trials-PRO Extension. Ethical approval was received from the Ethics Committees of the Medical Universities of Innsbruck (1347/2020) and Graz (33-056 ex 20/21), Austria. Results will be disseminated via national and international conferences and published in peer-reviewed journals., Trial Registration Number: DRKS00023978., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The fatigue-sleep disturbance-depression (FSD) symptom cluster, as one of the most common symptom clusters in breast cancer (BC) survivors, can significantly decrease patients' quality of life. Since the management of the FSD symptom cluster has been unsatisfactory with the use of pharmacological treatments alone, non-pharmacological approaches have, therefore, been recommended. Somatic acupressure (SA) is a promising approach given its potential benefits of cancer-related symptom alleviation and the convenience of self-practice. However, research evidence on using acupressure to manage the FSD symptom cluster has been limited. The proposed trial aims to examine the feasibility and preliminary effects of an evidence-based SA intervention for FSD symptom cluster management in BC survivors., Methods and Analysis: This study will be a phase II randomised controlled trial with three study arms and 1:1:1 allocation. Fifty-one early-stage BC survivors who are experiencing the FSD symptom cluster will be randomly assigned to a true SA group, a sham SA group or a usual care group. All participants will receive an education booklet regarding FSD symptom cluster management advice as the usual care package. The participants in the true SA group will additionally receive a 7-week self-administered SA intervention. The participants in the sham SA group will additionally receive self-administered light acupressure at non-acupoints with the same frequency, session and duration as the true SA group. The primary outcomes will be feasibility outcomes related to subject recruitment and completion of study questionnaires and interventions. The secondary outcomes will be the effects of SA on fatigue, sleep disturbance, depression and quality of life. Descriptive statistics will be used to present all the outcomes. The secondary outcomes will be analysed using an intent-to-treat approach., Ethics and Dissemination: Ethical approvals of this trial have been granted by the Human Research Ethics Committee at Charles Darwin University (H19017) and the Clinical Trial Ethics Committee at The Affiliated Hospital of Southwest Medical University (KY2019039). Findings from this trial will be published in peer-reviewed journals and presented at professional conferences., Trial Registration Number: This trial was registered at ClinicalTrials.gov and the registration number is NCT04118140, with the stage at Recruiting., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is one of the most common symptoms in patients with cancer and is responsible for a reduced quality of life. There is a strong evidence base for mind-body interventions (MBIs) to manage cancer-related fatigue (CRF). However, the efficacy of Tai Chi and other MBIs in the treatment of CRF remains controversial., Methods and Analysis: We will perform a systematic review and network meta-analyses (NMAs) that aim to assess the effects of Tai Chi and other MBIs in patients with CRF. The following databases will be searched from their inception to 1 August 2021: PubMed, EMBASE, Scopus, OVID, Web of Science, Cochrane Central Register of Controlled Trials, the China National Knowledge Infrastructure, China Science and Technology Journal Database, Chinese Biomedical Database and Wan Fang Digital Journals. We will include randomised controlled trials that compare MBIs with no treatment, placebo and usual care in the treatment of CRF. The primary outcome will be changes in the fatigue state as evaluated by validated scales. We will perform a Bayesian NMA to analyse all the evidence for each outcome. The surface under the cumulative ranking curve and the mean ranks will be used to rank the various treatments. We will assess the quality of evidence contributing to network estimates of outcomes using the Grading of Recommendations Assessment, Development and Evaluation system framework., Ethics and Dissemination: This NMAs will be disseminated through publication in a peer-reviewed journal. Since no individual patient data will be involved in the review, ethics approval and concerns about privacy are not needed., Prospero Registration Number: CRD42021244999., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related fatigue (CRF) is a prevalent symptom in cancer survivors. Transcutaneous electrical acupoint stimulation (TEAS) has been reported as a promising therapy for CRF. This protocol is proposed for a systematic review that aims to assess the efficacy and safety of TEAS for CRF., Methods and Analysis: Cochrane Central Register of Controlled Trials, PubMed, Medline, Embase, Chinese National Knowledge Infrastructure, VIP, Wanfang database, Chinese Biomedical Literature Database, Chinese Clinical Trial Registry System, ClinicalTrials.gov and WHO International Clinical Trial Registry Platform will be searched from inception to 31 January 2021 without language limitations. The eligible randomised controlled trials will be included. The primary outcomes include changes in the revised Piper fatigue scale, the Brief fatigue inventory, the Multidimensional fatigue inventory and the Functional assessment of chronic illness therapy fatigue. The secondary outcomes are the quality-of-life measurement index, the Hamilton anxiety scale, the Hamilton depression scale and adverse events. The selection of studies, data extraction and assessment of risk of bias will be conducted independently by two reviewers. Data synthesis will be performed using RevMan V.5.4.1. The quality of evidence will be evaluated with the Grading of Recommendations, Assessment, Development and Evaluation system. This study will strictly adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines., Ethics and Dissemination: Ethical approval is not required as this is a systematic review and meta-analysis based on previously published studies involving no private information of patients. The results of this study will be disseminated in a peer-reviewed journal., Prospero Registration Number: CRD42020220282., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is one of the most common and debilitating side effects in patients with breast cancer (BC) throughout their treatment trajectory. Tai chi has been supported as a promising non-pharmacological intervention for the individual symptom relief of cancer-related fatigue, sleep disturbance and depression. However, relevant evidence of using tai chi for FSDSC management in patients with BC has been lacking., Methods: This study will be a two-arm, single-blinded pilot randomised controlled trial involving an 8-week intervention and a 4-week follow-up. Seventy-two patients with BC experiencing the FSDSC will be recruited from two tertiary medical centres in China. The participants will be randomised to either a tai chi group (n=36) or a control group (n=36). The participants in the tai chi group will receive an 8-week tai chi intervention in addition to standard care, while the participants in the control group will receive standard care only consisting of a booklet on the self-management of cancer symptoms. The primary outcomes will include a series of feasibility assessments of the study protocol in relation to the study's methodological procedures, including subject recruitment and follow-up process, completion of study questionnaires and the feasibility, acceptability and safety of the intervention. The secondary outcomes will be the clinical outcomes regarding the effects of tai chi on the FSDSC and quality of life, which will be evaluated by the Brief Fatigue Inventory, the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale and the Functional Assessment of Cancer Therapy-Breast questionnaires., Ethics and Dissemination: Ethics approval was obtained from relevant sites (H19094, KY2019133, 201932). The findings of the study will be published in peer-reviewed scientific journals and at conferences., Trail Registration Number: NCT04190342; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare., Methods: Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20-50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up., Results: In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient's tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group., Conclusions: A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up., Trial Registration Number: BMC Registry (ISRCTN96836577)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patients with breast cancer (BC) cope with depression which is linked to functional limitations in survivorship and to physical symptoms. Pain and fatigue are prominent symptoms that affect the well-being of cancer survivors. Emotional processing has been associated with improved physical and psychological health in survivors. Art therapy is a form of psychotherapy that involves the use of visual art-making for expression and communication. It encourages emotional processing and has been linked to symptom reduction in patients with cancer. This protocol is designed to examine two mechanistic changes: emotional processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (heart rate variability and cytokine expression) through which an art therapy intervention may reduce depression, pain and fatigue. In addition, we will examine ethnocultural differences in the effect of art therapy in women from different ethnocultural backgrounds., Methods and Analysis: A randomised controlled study with careful controls will randomise 240 patient with BC (50% Jewish and 50% Arab) to an 8-week group art therapy intervention or an 8-week Mandala colouring comparison group. This design will test the mechanisms of art therapy on the targeted outcomes beyond the effects of time with a group, focus on a task and engagement with art materials. We will examine two potential mechanisms: emotional processing and cholinergic anti-inflammatory processes; of the intervention effects on depression, pain and fatigue and compare these effects in Arab versus Jewish women., Ethics and Dissemination: Participants will sign informed consent before participation and will be informed that they can leave the study at any point in time without effect on their medical treatment. The Helsinki committees of each participating hospital have approved the study. Data collected in this study will be published in peer-review journals, and we will use the platform of the study website (http://repat.haifa.ac.il/en/) for further dissemination to the general public., Trial Registration Number: The study is registered in ClinicalTrials.gov: NCT03377816; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as ' Managing Fatigue: A 6 week energy conservation course' , can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the Managing Fatigue intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function., Methods and Analysis: A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2 months, 3 months and 6 months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the Managing Fatigue intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes., Ethics and Dissemination: The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences., Trial Registration Number: NCT03550170; Pre-results., Competing Interests: Competing interests: FB has financial relationships with pharmaceutical and devices companies outside the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue., Methods and Analysis: Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning., Ethics and Dissemination: This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients., Trial Registration Number: ACTRN12619000952145; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

With survival after stroke improving, more people are discharged into the community with multiple and persistent deficits. Fatigue is a common unmet need for stroke survivors, but there are no evidence-based guidelines for its assessment and management. This study explored how UK-based therapists conceptualise post-stroke fatigue (PSF) in current practice., Objective: To describe current understanding of PSF among physiotherapists (PT) and occupational therapists (OT)., Design: A cross-sectional online survey using Qualtrics software (a survey creation and analysis programme) was sent to therapists working with stroke survivors in 2019. Responses to the open ended question, 'How would you describe PSF if approached by another healthcare professional?' were analysed thematically by two independent researchers., Participants: 137 survey respondents (71 PT and 66 OT) from a range of clinical settings (25 acute care, 24 sub-acute rehabilitation care, 3 primary care and 85 community care) with 7 months-36 years of experience working with stroke survivors completed the survey., Results: Respondents stated that PSF should be regarded as an important medical condition because it is common and can be associated with severe symptoms. Symptoms were perceived to be highly variable and the syndrome was difficult to define objectively. It was felt to have both physical and cognitive components. A variety of different opinions were expressed with regard to causation, conceptualisation and best management., Conclusion: Therapists working with stroke survivors conceptualise and manage PSF in different ways. Clinical practice is hampered by a lack of a widely adopted definition, and a small evidence base. Research into causes and management of PSF is a priority., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patient-reported outcome-based symptom monitoring and alerting have been attractive for patient care after a tumour-removal surgery. However, the implementation parameters of this patient-centred symptom management system in perioperative patients with lung cancer are still lacking. We aim to develop a perioperative symptom scale (PSS) for monitoring, to determine the optimal time points for symptom assessment and to define the alert thresholds for medical intervention., Methods and Analysis: This study will prospectively recruit 300 patients undergoing lung cancer surgery in six hospitals. The MD Anderson Symptom Inventory-Lung Cancer Module (MDASI-LC) is used to collect longitudinal symptom data preoperatively, daily postoperatively during in-hospital stay and weekly after discharge until 4 weeks or the start of postoperative oncological therapy. Symptoms that change significantly over time will be generated as the PSS. We will determine the optimal time points for follow-up using the generalised linear mixed-effects models. The MDASI-LC interference-measured functional status will be used as the anchor for the alert thresholds., Ethics and Dissemination: Ethics Committee of Sichuan Cancer Hospital approved this study on 16 October 2017 (No. SCCHEC-02-2017-042). The manuscript is based on the latest protocol of Version 3.0, 15 September 2019. The results of this study will be presented at medical conferences and published in peer-reviewed journals., Trials Registration Number: NCT03341377., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems., Methods and Analytics: One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group is asked to maintain their habitual activity pattern during 6 months. The primary outcome (verbal learning) is measured at baseline and 6 months. Further measurements include online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness. The MRI scans and blood sampling will be used to gain insight into underlying mechanisms. At 18 months online neuropsychological tests, self-reported cognitive complaints and patient-reported outcomes will be repeated., Ethics and Dissemination: Study results may impact usual care if physical exercise improves cognitive functioning for breast cancer survivors., Trial Registration Number: NTR6104., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Physical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia., Methods: Sixty women aged 18-60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment., Ethics and Dissemination: This protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins., Trial Registration Number: NCT03149198., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue., Methods and Analysis: LIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls., Ethics Approval and Dissemination: Ethical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants., Trial Registration Number: NCT03248518; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objective: Cancer treatment is a particularly stressful period for the patient. The reasons vary and include fear of treatment outcome as well as treatment induced side effects. The patient frequently experiences simultaneously various side effects resulting in a diminishing of the patient's health-related quality of life (HRQoL). The study provides evidence on the co-occurrence and inter-relations between pain, anxiety, depression and fatigue in patients with breast and prostate cancer., Design: This paper presents a secondary analysis of the data from a randomised control trial designed to test the effectiveness of guided imagery and progressive muscle relaxation on pain, fatigue, anxiety and depression. Non-parametric bootstrapping analyses were used to test the mediational model of anxiety, fatigue and depression as parallel mediators of the relationship between pain and HRQoL., Setting: The study was undertaken at the home setting., Participants: In total 208 patients were included in the study (assigned equally in two groups), referred at the outpatient clinics of the three participating cancer care centres., Results: The three mediators fully mediate the relationship between pain and HRQoL indirect effect (IE overall =-0.3839, 95% CI: lower limit (LL)=-0.5073 to upper limit (UL)=-0.2825) indicating that patients with increased pain are likely to have higher levels of anxiety, fatigue and depression. Gender significantly moderated the mediational effect of Fatigue Index of Moderated Mediation (IMM=-0.2867 SE=0.1526, LL=-0.6127, UL=-0.0226) but did not moderate mediational effect of anxiety (IMM=-0.0709, SE=0.1414, LL=-0.3459, UL=+0.2089). The results show that the three mediators in a serial causal order fully mediate the relationship between pain and HRQoL (IE overall =-0.384, 95% CI: LL=-0.51 to UL=-0.284) and the ratio of the overall indirect effect to the total effect is 0.8315 (95% CI: LL=0.5683 to UL=1.1718)., Conclusion: This work provides evidence that targeting fatigue, anxiety and depression may have a meaningful effect on pain as a related symptom and potentially have a positive impact on HRQoL of patients with breast and prostate cancer TRIAL REGISTRATION NUMBER: NCT01275872; Post-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients., Methods: We aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4-6 weeks' CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire-short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation., Ethics and Dissemination: A National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor., Trial Registration Number: ISRCTN91238019;Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To support return to work (RTW) among cancer patients, a multidisciplinary rehabilitation programme was developed which combined occupational counselling with a supervised physical exercise programme during chemotherapy. The aim was to investigate RTW rates of cancer patients and to evaluate changes in work-related quality of life and physical outcomes., Design: Longitudinal prospective intervention study using a one-group design., Setting: Two hospitals in the Netherlands., Participants: Of the eligible patients, 56% participated; 93 patients with a primary diagnosis of cancer receiving chemotherapy and on sick leave were included. Patients completed questionnaires on RTW, the importance of work, work ability (WAI), RTW self-efficacy, fatigue (MFI), and quality of life (EORTC QLQ C-30) at baseline and 6, 12 and 18 months follow-up. Before and after the exercise programme 1-repetition maximum (1RM) muscle strength and cardiorespiratory fitness (VO 2 peak) were assessed., Results: Six months after the start of a multidisciplinary rehabilitation programme that combined occupational counselling with a supervised physical exercise programme, 59% of the cancer patients returned to work, 86% at 12 months and 83% at 18 months. In addition, significant improvements (p<0.05) in the importance of work, work ability, RTW self-efficacy, and quality of life were observed, whereas fatigue levels were significantly reduced. After completing the exercise programme, 1RM muscle strength was significantly increased but there was no improvement in VO 2 peak level., Conclusions: RTW rates of cancer patients were high after completion of the multidisciplinary rehabilitation programme. A multidisciplinary rehabilitation programme which combines occupational counselling with a supervised physical exercise programme is likely to result in RTW, reduced fatigue and increased importance of work, work ability, and quality of life., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition, yet there is a limited evidence base for treatment. There is good evidence that graded exercise therapy is moderately effective in adults with CFS/ME, but there is little evidence for the effectiveness, cost-effectiveness, acceptability or best method of delivery for paediatric CFS/ME. This study aims to investigate the acceptability and feasibility of carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME., Methods and Analysis: 100 paediatric patients (8-17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial., Ethics and Dissemination: The trial has received ethical approval from the National Research Ethics Service (South West-Frenchay 15/SW/0124)., Trial Registration Number: ISRCTN23962803; Pre-results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Introduction: Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom., Objectives: This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment., Methods and Analysis: This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator., Participants: 80 post-treatment cancer survivors will be recruited for the study., Interventions: An 8-week online intervention based on cognitive-behavioural therapy., Primary and Secondary Outcome Measures: The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention., Results: The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes., Conclusions: This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment., Setting: Recruitment from general public in Ireland., Ethics and Dissemination: This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal., Trial Registration Number: ISRCTN55763085; Pre-results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objectives: To explore cross-sectional patterns of use of fatigue management strategies in people with multiple sclerosis (MS) who had attended a group-based fatigue management programme, Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle ('FACETS'). In a multicentre randomised controlled trial (RCT) the FACETS programme was shown to reduce fatigue severity and improve self-efficacy and quality of life., Design: A questionnaire substudy within a RCT involving the self-completed Fatigue Management Strategies Questionnaire (FMSQ). The FMSQ includes: (1) closed questions about the use and helpfulness of fatigue management strategies taught in FACETS and (2) open items about changes to lifestyle, attitudes or expectations, barriers or difficulties encountered and helpful strategies not covered in FACETS., Participants: All had a clinical diagnosis of MS, significant fatigue, were ambulatory and had attended at least 4 of 6 scheduled FACETS sessions., Methods: Participants (n=72) were posted the FMSQ with a prepaid return envelope 4 months after the end of the FACETS programme., Results: 82% (59/72) of participants returned the FMSQ. The fatigue management strategies most frequently used since attending FACETS were prioritisation (80%), pacing (78%), saying no to others (78%), grading tasks (75%) and challenging unhelpful thoughts (71%). Adding in those participants who were already using the respective strategies prior to FACETS, the three most used strategies at 4 months were prioritisation (55/59), grading (54/59) and pacing (53/58). Free-text comments illustrated the complex interplay between attitudes/expectations, behaviours, emotions and the environment. Issues related to expectations featured strongly in participants' comments. Expectations (from self and others) were both facilitators and barriers to effective fatigue management., Conclusions: Individuals' comments highlighted the complex, multifaceted nature of fatigue management. Revising expectations and a greater acceptance of fatigue were important shifts following the programme. Findings support the relevance of a cognitive behavioural approach for fatigue management. Booster sessions might be a useful addition to the FACETS programme., Trial Registration Number: Current controlled trials ISRCTN76517470; Results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive-behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability., Methods and Analysis: This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10-16 patients with RA (fatigue severity ≥ 6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5-6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5-8 patients will attend 6 × 2 h sessions (weeks 1-6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively., Ethics and Dissemination: Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings will be submitted to the National Institute for Health and Care Excellence, Clinical Commissioning Groups and all UK rheumatology departments., Isrctn: 52709998; Protocol v3 09.02.2015., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)