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Objective: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. Methods: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face‐to‐face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention‐to‐treat population was distress severity (Brief Symptom Inventory; BSI‐18) immediately post‐intervention (T1). Results: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention‐to‐treat analysis, the intervention significantly reduced distress immediately post‐intervention (−3.86 points, 95% CI −7.00 to −0.73) and at 7 months post‐randomization (−3.88 points, 95% CI −6.95 to −0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer‐specific distress were significantly lower in the intervention arm. Self‐efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. Conclusions: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. Trial Registration: Netherlands Trial Register NTR6025. [ABSTRACT FROM AUTHOR]

Objective: We performed a randomized controlled trial (RCT) to investigate whether regular screening with the distress thermometer (DT) by a nurse improved global quality of life (QOL) of patients with breast cancer (BC) treated with curative intent.Methods: BC patients were randomized between regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC). Both groups filled out questionnaires at baseline, after each received treatment modality and at follow-up visits up to 2 years. At these points, the intervention group received also the NDTI. The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after the end of treatment. Analyses were done on an intention-to-treat basis, using analysis of covariance (ANCOVA), generalized least squares, and interaction analyses.Results: Of 194 randomized patients, 153 filled out the questionnaires up to 2 years after treatment. There was no significant difference between NDTI and UC in global QOL 2 years after the end of treatment (mean diff. = -1∙273, P = .610; 95% CI [-6.195; 3.649]). Subgroup analysis of patients who received multimodality treatment (surgery, radiotherapy, and chemotherapy, n = 66) showed a significant between-group difference in global QOL over time (mean diff. = -10, P < .001; 95% CI [-14.835; -5.167]) together with other secondary outcome measures in favor of the NDTI.Conclusion: NDTI did not lead to a significant improvement in global QOL 2 years after the end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment may benefit from NDTI. [ABSTRACT FROM AUTHOR]

The article compares consecutive sampling and self-referral recruitment methods for psycho-oncology intervention (POI) randomized controlled trials (RCT), defined as interventions to manage the psychological, behavioural, and/or social aspects of cancer to promote health. Topics covered include how POI differ from many other cancer treatments, the ability of self-referral recruitment to enhance patient-centred care, and ethical aspects of self-referral recruitment methods.

Purpose: The CONDOR study showed that docetaxel/cisplatin/5-fluorouracil (TPF) followed by conventional radiotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 (cis100 + RT; n = 27)) versus accelerated radiotherapy with cisplatin weekly 40 mg/m2 (cis40 + ART; n = 29) in locally advanced head and neck cancer (LAHNC) patients was not feasible. Here, we report the analysis of health-related quality of life (HRQOL) of the patients entered in this study.Methods: HRQOL was assessed at baseline, after two TPF, before start of chemoradiotherapy, and 1, 4, 8, 12, and 24 months after completion of chemoradiotherapy using the EORTC-QLQ-C30 and QLQ-H&N35 in 62 patients.Results: Compliance with the QOL questionnaires was 94% (59/62) at baseline and 61% (30/49) at 12 months, respectively. HRQOL decreased after TPF and further decreased during chemoradiohteray in both arms equally. Pain and swallowing dysfunction improved significantly during TPF but deteriorated below baseline levels during chemoradiotherapy, cis40 + ART > cis100 + RT (p < 0.05). HRQOL and symptoms restored to baseline within 12 months in both arms and remained at that level until 24 months.Conclusions: After TPF, cis40 + ART had a larger negative impact on symptoms than cis100 + RT, probably due to the ART. HRQOL and symptoms restored to baseline levels within 12 months after end of treatment in both arms, which is an important perspective for patients during the phase of most serious acute side effects of treatment.Trial Registration: NCT00774319. [ABSTRACT FROM AUTHOR]

Objective:The aim was to investigate whether additional information, in video form, reduces anxiety, depression and pain levels in women referred for colposcopy. Material and methods:Between September 2012 and March 2015, 136 patients referred for colposcopy were randomized into two study arms. Group A received video information in addition to the regular information leaflet, and group B (control group) received only the regular information leaflet. The patients were requested to complete standardized online questionnaires. The first online questionnaire (T1) was pre-randomization, and was completed at home, 5 days prior to the appointment. The second online questionnaire (T2) was completed directly before the colposcopy appointment, and the last online questionnaire (T3) was completed directly following colposcopy at the out-patient clinic. The questionnaires included the Spielberger State-Trait Anxiety Inventory (STAI), the Hospital Anxiety and Depression Scale (HADS), and the Numeric Rating Scale (NRS) to assess pain. Results:The STAI state anxiety score was high (44.6), but there was no significant difference in STAI, HADS and NRS between the two groups at the three measuring points. Apost hocanalysis showed that women with a generally higher baseline anxiety trait had significantly lower HADS anxiety levels following video information. Conclusions:Additional information (video) before colposcopy did not significantly reduce anxiety, depression, and expected or experienced pain, as measured by the STAI, HADS and NRS in patients attending their first colposcopy appointment. However, most patients positively appreciated the video information, which may reduce the anxiety of extremely anxious patients. [ABSTRACT FROM PUBLISHER]

Background: Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management. Moreover, self-management interventions intend to enhance knowledge and skills and empower patients to better manage their disease and related problems. The objective of the Lymphoma InterVEntion (LIVE) trial is to examine whether feedback to patients on their PROs and access to a web-based, self-management intervention named Living with lymphoma will increase self-management skills and satisfaction with information, and reduce psychological distress.Methods/design: The LIVE randomised controlled trial consists of three arms: (1) standard care, (2) PRO feedback, and (3) PRO feedback and the Living with lymphoma intervention. Patients who have been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, including chronic lymphocytic leukaemia, as registered in the Netherlands Cancer Registry in various hospitals will be selected for participation. Patients are invited via their haemato-oncologist 6 to 15 months after diagnosis. The PRO feedback includes a graphical overview of patients' own symptom and functioning scores and an option to compare their scores with those of other patients with lymphoma and a normative population of the same age and sex. The Living with lymphoma intervention is based on cognitive behavioural therapy components and includes information, assignments, assessments, and videos. Changes in outcomes from baseline to 16 weeks, 12, and 24 months post intervention will be measured. Primary outcomes are self-management skills, satisfaction with information, and psychological distress. Secondary outcomes are health-related quality of life, illness perceptions, fatigue, and health care use.Discussion/design: The results of the LIVE trial will provide novel insights into whether access to PRO feedback and the Living with lymphoma intervention will be effective in increasing self-management skills and satisfaction with information, and reducing distress. The LIVE trial is embedded in a population-based registry, which provides a unique setting to ascertain information on response, uptake, and characteristics of patients with lymphoma in web-based intervention(s). When effective, PRO feedback and Living with lymphoma could serve as easily and widely accessible interventions for coping with lymphoma.Trial Registration: Netherlands Trial Register, identifier NTR5953 . Registered on 14 July 2016. [ABSTRACT FROM AUTHOR]

Background: Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT on the psychosocial wellbeing of the patient are unknown. A study to assess the psychosocial consequences of the systematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer is needed.Methods/design: The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded randomized controlled trial. Patients treated with curative intent for breast cancer will be recruited from the Radboud University Medical Center. The intervention consists of the DT together with discussion of the results with the patient by a trained oncology nurse added to the usual care. Patients will be randomly allocated (1:1) to either receive usual care or the usual care plus the intervention. Primary outcome measure is global quality of life measured with the EORTC QLQ-C30. The functional and symptom scales of the EORTC QLQ-C30 and BR23, Hospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline and final measurement only) will be used to measure secondary outcomes. Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three and six months' interval during the first and second year respectively.Discussion: This study will be the first randomized controlled longitudinal study about the effectiveness of the DT as nurse led-intervention. In case of proven effectiveness, future implementation and standardization of use of the DT as part of routine care will be recommended.Trial Registration: This study is registered at clinicaltrial.gov march 17, 2010 ( NCT01091584 ). [ABSTRACT FROM AUTHOR]

Background.Group medical consultations (GMCs) provide individual medical visits in the presence of ≤ 7 peer- patients. This study evaluated the efficacy of GMCs in the yearly breast cancer surveillance ofBRCAmutation carriers. Material and methods.This randomized controlled trial compared GMCs (intervention group, n = 63) with individual medical visits (control group, n = 59). Between-group differences on the primary outcomes distress and empowerment, were analyzed one week and three months after the visit. Feasibility is evaluated in terms of demand, acceptability and practicability. Results.No between-group differences were found on primary outcomes. More themes were discussed in GMCs. Seventy-five percent of GMC-participants experienced peer support. Carriers reported significantly higher satisfaction with individual visits. GMCs were less time-efficient. Conclusion.This is the first GMC study which reports results in favor of individual visits. The hereditary nature of the condition differentiates our study population from earlier studied GMC groups. Even though most participants experienced peer support and received more information, the lower patient satisfaction may be explained by the lack of individual time with the clinician and disruption of normal surveillance routines. As the need for peer support and additional information is present in a substantial part of carriers, future research should study the process of peer support. [ABSTRACT FROM PUBLISHER]

Background: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated. Methods: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed. Discussion: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL. [ABSTRACT FROM AUTHOR]

Background Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. Methods/Design A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. Discussion This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners. Trial registration ClinicalTrials.gov NCT01494883. [ABSTRACT FROM AUTHOR]

Objective: The Pictorial Representation of Self and Illness Measure (PRISM) measures in a simple, graphic way the burden of suffering due to illness. The question addressed in this study is whether the PRISM is a valid instrument to measure suffering in cancer survivors experiencing severe fatigue. Method: Quantitative and qualitative data of a previous randomized controlled trial demonstrating the efficacy of cognitive behavior therapy (CBT) especially designed for postcancer fatigue was used to assess convergent validity and sensitivity to change in a sample of 83 cancer survivors. Measures: The PRISM, yielding self-illness separation (SIS-fatigue = suffering due to fatigue; SIS-cancer = suffering due to cancer), fatigue severity (Checklist Individual Strength; CIS-fatigue), functional impairment, psychological well-being, quality of life, and coping with the experience of cancer (Impact of Event Scale; IES). Results: Moderate significant correlations were found with the PRISM and the above mentioned measures. On the basis of SIS scores, the sample was divided into two separate groups: cancer survivors who suffered more because of fatigue and cancer survivors who suffered more because they had cancer in the past. The two groups had different scores on CIS-fatigue and IES, in line with that aspect that caused them the most suffering. The qualitative data confirmed this finding. Participants in the CBT condition demonstrated a significant difference between SIS-fatigue at baseline versus 6 months later compared with those in the waiting list condition. No change of SIS-cancer was found. Conclusion: The PRISM seems to be a valuable tool in fatigue research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek help, or perceive the threshold as too high. Since almost all children of the current generation have access to the internet, an online intervention will make help better available for this target group. In 2011, an internet-based selfsupport method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: "Feel the ViBe". The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT to study the effectiveness of this intervention. Methods/design: This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to "Feel the ViBe" and usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health and sexual and reproductive health. Routine Outcome Measurement (ROM) will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen's d effect sizes will be used. Discussion: A RCT and process evaluation will test effectiveness and provide information of how the effects can be explained, how the intervention meets the expectation of participants and which possible barriers and facilitators for implementation exist. A qualitative analysis of the data will add information to interpret the quantitative data. This makes "Feel the ViBe" unique in its field. [ABSTRACT FROM AUTHOR]

Background: Adolescents and young adults (AYAs) are of special interest in a group of children exposed to family violence (FV). Past-year prevalence of exposure to FV is known to be highest in AYAs and has severe consequences. Peer support is an effective approach to behavior change and the Internet is considered suitable as a mode of delivery.Objective: The study aimed to evaluate both effectiveness and feasibility of a randomized controlled trial (RCT) and feasibility study of the Internet-based self-support method "Feel the ViBe" (FtV) using mixed-methods approach to fully understand the strengths and weaknesses of a new intervention.Methods: AYAs aged 12-25 years and exposed to FV were randomized in an intervention group (access to FtV + usual care) and a control group (minimally enhanced usual care) after they self-registered themselves. From June 2012 to July 2014, participants completed the Impact of Event Scale (IES) and Depression (DEP) and Anxiety (ANX) subscales of the Symptom CheckList-90-R (SCL-90) every 6 weeks. The Web Evaluation Questionnaire was completed after 12 weeks. Quantitative usage data were collected using Google analytics and content management system (CMS) logs and data files. A univariate analysis of variance (UNIANOVA) and mixed model analysis (intention-to-treat [ITT], complete case) were used to compare groups. Pre-post t tests were used to find within-group effects. Feasibility measures structurally address the findings. The CONsolidated Standards Of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH) checklist was closely followed.Results: In total, 31 out of 46 participants in the intervention group and 26 out of 47 participants in the control group started FtV. Seventeen participants (intervention: n=8, control: n=9) completed all questionnaires. Mixed model analysis showed significant differences between groups on the SCL-90 DEP (P=.04) and ANX (P=.049) subscales between 6 and 12 weeks after participation started. UNIANOVA showed no significant differences. Pre-post paired sample t tests showed significant improvements after 12 weeks for the SCL-90 DEP (P=.03) and ANX (P=.046) subscales. Reported mean Web-based time per week was 2.83 with a session time of 36 min. FtV was rated a mean 7.47 (1-10 Likert scale) with a helpfulness score of 3.16 (1-5 Likert scale). All participants felt safe. Two-thirds of the intervention participants started regular health care.Conclusions: No changes on the IES were found. SCL-90 DEP and ANX showed promising results; however, the calculated sample size was not reached (n=18). FtV functions best as a first step for adolescents and young adults in an early stage of change. FtV can be easily implemented without extensive resources and fits best in the field of public health care or national governmental care.Trial Registration: Netherlands National Trial Register (NTR): NTR3692; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=3692 (Archived by WebCite at http://www.webcitation.org/6qIeKyjA4). [ABSTRACT FROM AUTHOR]

Background: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. Objective: To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. Methods: The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. Results: Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (P<.001), total duration (P<.001), session duration (P=.009), and activity (P<.001). High users logged in an average of 21 times, had a mean session duration of 33 minutes, and opened on average 91% of all ingredients. Signing the self-help contract (P<.001), reporting usefulness of ingredients (P=.003), overall satisfaction (P=.028), and user friendliness evaluation (P=.003) were higher in high users. User groups did not differ on age, education, and baseline distress. Conclusions: By reporting the usage of a self-management website for breast cancer survivors, the present study gained first insight into the design of usage evaluations of generic fully automated Web-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. Trial Registration: Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV). [ABSTRACT FROM AUTHOR]

Abstract: Objective: Cognitive behavior therapy (CBT) leads to a significant reduction in fatigue severity and impairment in patients with chronic fatigue syndrome (CFS). The purpose of the present study was to determine whether the effect of CBT for CFS on fatigue and impairment is mediated by a decrease in avoidance behavior and focusing on fatigue. Methods: For this purpose, we reanalyzed a randomized controlled trial which was previously conducted to test the efficacy of CBT for CFS. Two hundred nineteen patients completed assessment prior and subsequent to treatment or a control group period. Results: Mediation analysis revealed that a decrease in focusing on fatigue mediated the effect of CBT for CFS on fatigue and impairment. Avoidance of activity and avoidance of aversive stimuli were not significantly changed by treatment and were therefore excluded from mediation analysis. Conclusion: A decrease in the focus on fatigue seems to contribute to the treatment effect of CBT for CFS. [Copyright &y& Elsevier]