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PURPOSE The European Organisation for Research and Treatment of Cancer (EORTC) Item Library is an interactive online platform currently composed of 950 unique items (questions) derived from 67 patient-reported outcome (PRO) questionnaires. PROs complement clinician adverse event (AE) reporting classifications like the Common Terminology Criteria for Adverse Events (CTCAE). This work aims to create a standardized framework using the CTCAE to systematically classify symptomatic AEs from the EORTC Item Library through linking individual items to corresponding AEs. METHODS The EORTC Item Library items were searched for within the CTCAE (v5.0) and linked to an AE if they were described within the AE's title, description, or grading. Symptoms described in EORTC items but not located in the CTCAE were coded as missing symptoms. Other nonsymptom EORTC items, not described within the CTCAE were assigned a non-CTCAE descriptive classification. Further descriptive codes (eg, multiple issues) were allocated to enable descriptive analysis. Two raters independently coded 26.2% (n = 249) of the items. The remaining 701 items were coded by one rater and verified by the second, followed by discussion with two additional raters to reach consensus. RESULTS Overall, 625 (65.8%) EORTC items were linked to 208 different AEs. Three hundred sixty-nine items provide information about non-CTCAE cancer–related issues and were categorized into seven descriptive classifications, including body image; emotional impact of a symptom, diagnosis, or treatment; global health and quality of life; and impact on life and daily activities. Inter-rater agreement for independent coding was 79.1%. Bowel urgency and tenesmus were identified as missing symptoms in CTCAEv5.0. CONCLUSION The EORTC Item Library provides considerable coverage of CTCAE toxicities, along with other complementary issues important to patients with cancer. Using the CTCAE clinical framework to classify symptomatic PRO items may facilitate PRO selection and use in clinical trials and routine care.

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit–risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

BACKGROUND Electronic Patient Reported Outcomes (ePROs) are commonly used in oncology clinical practice and have shown benefits for patients and health resource use. This review and meta-analysis examined effectiveness of ePROs compared to usual care for health-related outcomes in people with cancer. OBJECTIVE To compare the single effect of administering ePROs to patients with cancer versus a control condition. METHODS Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Randomised controlled trials evaluating ePRO interventions, improving health-related outcomes, among cancer patients were included. Primary outcome: health-related quality of life (HRQOL). Secondary outcomes: symptoms, hospital admissions, unplanned visits, chemotherapy completion, survival, and satisfaction with care. Effect size of ePROs on health-related outcomes were analysed as standardised mean differences with 95% confidence intervals using the random effects model. RESULTS The search identified 10965 papers. Nineteen papers from 15 studies were included. Meta-analysis showed an improvement in HRQOL at three months, measured by the Functional Assessment of Cancer Therapy- General (FACT-G) (SMD: 0.28 95% CI: -1.22 to 1.78), and at six months with various HRQOL measures (SMD: 0.07 95% CI: -1.24 to 1.39). Results should be interpreted with caution given the wide confidence intervals. Nine studies reported a positive signal on HRQOL with six including tailored patient advice and six using clinician alert systems. CONCLUSIONS Meta-analysis showed a potential improvement in HRQOL at six months and in FACT-G scores at three months for studies that included tailored advice and clinician alerts suggesting these elements may improve ePRO effectiveness. Findings will provide guidance for future use and help healthcare professionals choose the most suitable ePRO features for their patients.

Remarkable improvements in outcomes for many haematological malignancies have been driven primarily by a proliferation of novel therapeutics over the past two decades. Targeted agents, immune and cellular therapies, and combination regimens have adverse event profiles distinct from conventional finite cytotoxic chemotherapies. In 2018, a Commission comprising patient advocates, clinicians, clinical investigators, regulators, biostatisticians, and pharmacists representing a broad range of academic and clinical cancer expertise examined issues of adverse event evaluation in the context of both newer and existing therapies for haematological cancers. The Commission proposed immediate actions and long-term solutions in the current processes in adverse event assessment, patient-reported outcomes in haematological malignancies, toxicities in cellular therapies, long-term toxicity and survivorship in haematological malignancies, issues in regulatory approval from an international perspective, and toxicity reporting in haematological malignancies and the real-world setting. In this follow-up report, the Commission describes progress that has been made in these areas since the initial report.

Background The availability of high-quality patient-reported outcome (PRO) data is crucial to guiding shared decision-making in the context of locally recurrent rectal cancer (LRRC), where potential treatment benefits must be balanced against the impact of both the disease and treatment on PROs, such as quality of life. This review aimed to identify the patient-reported outcome measures (PROMs) currently being reported in LRRC and to appraise the methodological quality of studies using these measures. Methods PubMed, Embase and CINAHL databases were searched, including studies published up until 14th September 2022. Studies in adults with LRRC reporting PROMS as a primary or secondary outcome measure were included. Data were extracted concerning the methodological quality of the reporting of PROMs using criteria informed by the CONSORT-PRO checklist and the psychometric properties of the PROMs identified using the COSMIN Risk of Bias checklist. Results Thirty-five studies including 1914 patients with LRRC were identified. None of the studies included in the review met all eleven criteria for the quality of reporting of PROMs. Seventeen PROMs and two clinician-reported outcome measures were identified, none of which have been validated for use in patients with LRRC. Conclusions None of the PROMs which are currently being used to report PROs in LRRC have been validated for use in this cohort of patients. Future studies in this disease area should focus on utilising PROMs that have undergone a robust development process including patients with LRRC, to produce data which is high quality, accurate and relevant.

Background Overall survival rates for locally recurrent rectal cancer (LRRC) continue to improve but the evidence concerning health-related quality of life (HrQoL) remains limited. The aim of this study was to describe the short-term HrQoL differences between patients undergoing surgical and palliative treatments for LRRC. Methods An international, cross-sectional, observational study was undertaken at five centres across the UK and Australia. HrQoL in LRRC patients was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 and functional assessment of cancer therapy – colorectal (FACT-C) questionnaires and subgroups (curative versus palliative) were compared. Secondary analyses included the comparison of HrQoL according to the margin status, location of disease and type of treatment. Scores were interpreted using minimal clinically important differences (MCID) and Cohen effect size (ES). Results Out of 350 eligible patients, a total of 95 patients participated, 74.0 (78.0 per cent) treated with curative intent and 21.0 (22.0 per cent) with palliative intent. Median time between LRRC diagnosis and HrQoL assessments was 4 months. Higher overall FACT-C scores denoting better HrQoL were observed in patients undergoing curative treatment, demonstrating a MCID with a mean difference of 18.5 (P < 0.001) and an ES of 0.6. Patients undergoing surgery had higher scores denoting a higher burden of symptoms for the EORTC CR29 domains of urinary frequency (P < 0.001, ES 0.3) and frequency of defaecation (P < 0.001, ES 0.4). Higher overall FACT-C scores were observed in patients who underwent an R0 resection versus an R1 resection (P = 0.051, ES 0.6). EORTC CR29 scores identified worse body image in patients with posterior/central disease (P = 0.021). Patients undergoing palliative chemoradiation reported worse HrQoL scores with a higher symptom burden on the frequency of defaecation scale compared with palliative chemotherapy (P = 0.041). Conclusion Several differences in short-term HrQoL outcomes between patients undergoing curative and palliative treatment for LRRC were documented. Patients undergoing curative surgery reported better overall HrQoL and a higher burden of pelvic symptoms.

Introduction: Early guidelines for minimally important differences (MID) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types. Methods: Data were obtained from 21 published EORTC Phase III trials that enrolled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs. Results: Anchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates. Conclusions: Our results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.

Purpose Ovarian cancer patients require monitoring for relapse post-treatment, and alternative follow-up pathways are increasing, which require in-depth exploration to ensure acceptability and inform implementation. This study aimed to explore women and specialist nurses’ experiences of participating in a feasibility study of an electronic patient-reported outcome (ePRO) follow-up pathway after ovarian cancer treatment. Methods The feasibility study incorporated an ePRO questionnaire, blood test and telephone consultation with a specialist nurse, instead of face-to-face hospital visits. All women and the nurses involved were invited to take part in nested semi-structured interviews. Interviews were recorded and transcripts analysed using framework analysis. Results Twenty interviews were conducted (16 out of 24 women who took part in the feasibility study and all 4 nurses). Four themes were identified: (1) readiness and motivators, (2) practicalities and logistics, (3) personal impact and (4) future role. An overarching theme highlighted how women strived to seek reassurance and gain confidence. Most women and nurses were positive about the ePRO pathway and would happily continue using it. Conclusion This work provides invaluable insight into the experiences of women on remote ePRO follow-up post-treatment. Important logistic and implementation issues were identified, which should inform future large-scale work to introduce and evaluate remote ePRO methods in cancer follow-up. This work highlights the key factors influencing women’s readiness and acceptability of an ePRO pathway, and how services should be carefully designed to ensure patients feel reassured and confident post-treatment. Furthermore, it highlights that flexibility and patient preference should be considered in remote service delivery. Trial registration ClinicalTrials.gov ID: NCT02847715 (first registered 19 May 2016).

We investigated the association between preoperative quality of life and long-term survival in patients undergoing surgical resection for non-small cell lung cancer.Retrospective analysis was conducted on 388 consecutive patients who completed the quality of life assessment through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and lung cancer specific module (LC13), before anatomic lung resection for non-small cell lung cancer (2014-2018). Survival distribution was estimated by the Kaplan-Meier method. Cox proportional hazards regression and competing risk regression analyses were used to assess the independent association of preoperative patient-reported outcomes with overall and cancer-specific survival.Higher score in patient-reported physical functioning was significantly associated with longer overall survival. Factors significantly associated with poorer overall survival remained older age (P = .005), low body mass index (P = .007), male sex (P.001), and nodal involvement (P = .007). Competing regression analysis found that worse baseline lung cancer-specific dyspnea (P = .03), low body mass index (P = .01), worse performance status (P = .03), and lymph node involvement (P = .01) were significantly associated with poorer cancer-specific survival.Higher patient-reported physical function score was associated with longer overall survival after resection. Our study highlights the significance of routinely collecting quality of life data to aid preoperative decision making in non-small cell lung cancer.

Background Physical activity (PA) is associated with improved health-related quality of life (HRQoL) among women with breast cancer; however, uncertainty remains regarding PA types and dose (frequency, duration, intensity) and various HRQoL measures. A systematic review and meta-analysis of randomized controlled trials was conducted to clarify whether specific types and doses of physical activity was related to global and specific domains of HRQoL, as part of the Global Cancer Update Programme, formerly known as the World Cancer Research Fund–American Institute for Cancer Research Continuous Update Project. Methods PubMed and CENTRAL databases were searched up to August 31, 2019. Weighted mean differences (WMDs) in HRQoL scores were estimated using random effects models. An independent expert panel graded the evidence. Results A total of 79 randomized controlled trials (14 554 breast cancer patients) were included. PA interventions resulted in higher global HRQoL as measured by the Functional Assessment of Cancer Therapy–Breast (WMD = 5.94, 95% confidence intervals [CI] = 2.64 to 9.24; I2 = 59%, n = 12), Functional Assessment of Cancer Therapy–General (WMD = 4.53, 95% CI = 1.94 to 7.13; I2 = 72%, n = 18), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–C30 (WMD = 6.78, 95% CI = 2.61 to 10.95; I2 = 76.3%, n = 17). The likelihood of causality was considered probable that PA improves HRQoL in breast cancer survivors. Effects were weaker for physical function and mental and emotional health. Evidence regarding dose and type of PA remains insufficient for firm conclusions. Conclusion PA results in improved global HRQoL in breast cancer survivors with weaker effects observed for physical function and mental and emotional health. Additional research is needed to define the impact of types and doses of activity on various domains of HRQoL.

IntroductionA large and growing number of patients with cancer have comorbid diabetes. Cancer and its treatment can adversely impact glycaemic management and control, and there is accumulating evidence that suboptimal glycaemic control during cancer treatment is a contributory driver of worse cancer-related outcomes in patients with comorbid diabetes. Little research has sought to understand, from the perspective of patients and clinicians, how and why different aspects of cancer care and diabetes care can complicate or facilitate each other, which is key to informing interventions to improve diabetes management during cancer treatments. This study aims to identify and elucidate barriers and enablers to effective diabetes management and control during cancer treatments, and potential intervention targets and strategies to address and harness these, respectively.Methods and analysisQualitative interviews will be conducted with people with diabetes and comorbid cancer (n=30–40) and a range of clinicians (n=30–40) involved in caring for this patient group (eg, oncologists, diabetologists, specialist nurses, general practitioners). Semistructured interviews will examine participants’ experiences of and perspectives on diabetes management and control during cancer treatments. Data will be analysed using framework analysis. Data collection and analysis will be informed by the Theoretical Domains Framework, and related Theory and Techniques Tool and Behaviour Change Wheel, to facilitate examination of a comprehensive range of barriers and enablers and support identification of pertinent and feasible intervention approaches. Study dates: January 2021–January 2023.Ethics and disseminationThe study has approval from National Health Service (NHS) West Midlands—Edgbaston Research Ethics Committee. Findings will be presented to lay, clinical, academic and NHS and charity service–provider audiences via dissemination of written summaries and presentations, and published in peer-reviewed journals. Findings will be used to inform development and implementation of clinical, health services and patient-management intervention strategies to optimise diabetes management and control during cancer treatments.

Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry (ISRCTN10487576, 16/12/2021).

Background: Breast cancer is the most commonly diagnosed women’s cancer with 2.3 million new global cases diagnosed in 2020. The global rise in survivorship has resulted in a significant health and economic burden on society. Breast cancer survivors report being overwhelmed physically and emotionally with treatment adverse effects. Recommendations include self-management support and personalised follow-up to meet patient needs. Persistent post-surgical pain (PPSP) is the most common negative consequence of breast surgery, often relating to inadequate acute post-surgical pain management. An unintended consequence of day surgery is reduced post-operative pain monitoring. There is a need to ensure appropriate support and pain monitoring alongside preparation, behavioural change and expectation management. Web-based interventions (WBI) could be a potential solution. A mixed-methods approach was used to develop a WBI to capture patient self-reported post-operative symptoms and provide individualised self-management advice. Methods: An audit and service evaluation revealed a 46% PPSP rate and identified opportunities where advice could support improved self-management. Developing the WBI (ePainQ) comprised a scoping review, systematic review, and development study with all results informing the development of ePainQ. ePainQ comprised two parts; a website containing supportive information and a post-operative symptom questionnaire. Intervention questions included pain, swelling, infection, functionality and QoL. Advice was generated for each question with different levels, based on CTCAE grading agreed with clinicians. A feasibility study prospectively tested ePainQ for acceptability, usability and perceived usefulness. Feasibility study aims were assessing uptake, retention, follow up and completion rates and acceptability of ePainQ. Study arms: usual care (cohort) or intervention (ePainQ). Intervention: daily online symptom questionnaire for 2 weeks commencing the day after surgery. Participants received immediate advice based on the severity of the reported symptoms, either self-management advice or in cases of clinical concern, advice to contact the hospital team. Reports were immediately available to HCPs as ePainQ was linked to the electronic patient record. Data collection: baseline, 2 weeks, 3 and 9 months post-operatively. Outcome measures: EORTC C30, and BR23, EQ-5D, HADS and BPI. Patient Activation was measured at baseline and 9 months. Results: 69 patients recruited over 8 months; 60 intervention and 9 cohort. Mean age: 57.7yrs (SD 9.8; range 38-82). Recruitment rate was 63%. IT issues prevented 12/60 using ePainQ but engagement of the 48/60 active participants was 89.6%. 40/48 completed a usability scale in which • 97.5% highlighted ePainQ as easy to use • 95% reported not needing any technical support • 90% felt very confident using ePainQ Outcome measures: 69/69 (100%) completion at baseline and 2 weeks. No active withdrawals with 13/69 passive withdrawals by 9 months. 67 participants (97.1%) consented to an interview invite with 14/67 interviews conducted. Participants were a mix of compliance rates to be reflective of the study and capture both positive and negative feedback. Feasibility study results demonstrated that ePainQ was perceived to be simple, easy to use and not requiring much learning to use effectively. All pre-set criteria for progression to a phase III RCT were met. Conclusion: ePainQ was designed in response to patient identified needs. The feasibility study established that ePainQ was accepted, used, and liked by participants who interacted with it. Even participants with limited use felt they had benefited from the advice. Results demonstrated patient positivity towards ePainQ suggesting recruitment rates could be increased if research capacity was improved and higher retention rates if IT issues were resolved and daily reporting duration was slightly reduced. Citation Format: Sue M. Hartup, Laura Ashley, Michelle Briggs, Galina Velikova, Mark Johnson. Developing and feasibility testing a web-based intervention (ePainQ) to support post-operative pain and symptom self-management following surgery for breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-57.

Background Glioma diagnosis can be devastating and result in a range of symptoms. Relatively little is known about the long-term health-related quality of life (HRQOL) challenges faced by these patients. Establishing the impact of diagnosis on HRQOL could help positively tailor clinical decision making regarding patient support and treatment. The aim of this review is to identify the long-term HRQOL issues reported at least 2 years following diagnosis of WHO grade II/III glioma. Method Systematic literature searches were carried out using Medline, EMBASE, CINAHL, PsycINFO, and Web of Science Core Collection. Searches were designed to identify patient self-reports on HRQOL aspects defined as physical, mental, or social issues. Quality assessment was conducted using the Mixed Methods Appraisal Tool (MMAT). Narrative synthesis was used to collate findings. Results The search returned 8923 articles. Two hundred seventy-eight titles remained after title and abstract screening, with 21 full-text articles included in the final analysis. The majority of studies used quantitative methods, with 3 articles reporting mixed methodology. Negative emotional/psychological/cognitive changes were the most commonly reported. Physical complaints included fatigue, seizures, and restricted daily activity. Social challenges included strained social relationships and financial problems. Patient coping strategies were suggested to influence patient’s survival quality. Conclusion The consequences of a glioma diagnosis and treatment can have substantial implications for patients’ long-term HRQOL and daily functioning. Findings from this review lay the groundwork for efforts to improve patient HRQOL in long-term survivorship.

Radiation therapy (RT) and chemoRT for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system.In a prospective 2-center randomized parallel-group pilot study, patients undergoing radical pelvic RT for prostate cancer (prostateRT) or chemoRT for lower gastrointestinal and gynecological cancers were randomized to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18, and 24 weeks). Primary outcomes were recruitment/attrition, study completion, and patient adherence. Secondary outcomes were effect on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for Functional Assessment of Cancer Therapy (FACT-G), European Organisation for Research and Treatment of Cancer, Quality of Life (EORTC QLQ C-30), self-efficacy, and EuroQol (EQ5D).From 228 patients approached, 167 (73.2%) were consented and randomized (83, eRAPID; 84, UC; 87, prostateRT; 80, chemoRT); 150 of 167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10, eRAPID; 6, UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared with chemoRT (week 1, 93% vs 69%; week 2, 93% vs 68%; week 12, 69% vs 55%). Overall, over 50% of online reports triggered self-management advice for milder adverse events. Unscheduled hospital contact was low, with no difference between eRAPID and UC. Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data were low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale, and FACT-Physical Wellbeing. At 6 weeks, the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30, and EQ5D-Visual Analogue Scale than UC, after baseline adjustment.eRAPID was successfully added to UC at 2 cancer centers in different patient populations. Acceptability and feasibility were confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynecological cancers.

Health-related quality of life (HRQOL) is increasingly recognized as important when evaluating cancer treatments. The use, reporting, and analysis of patient-reported outcome measures (PROMs), however, are not standardized in clinical trials and are often poorly implemented in clinical practice. We report the results of a systematic literature review (PubMed search: January 1, 2000 to August 15, 2020) of PROM use, reporting, and analysis in phase 3 clinical trials of hormone receptor–positive (HR+) advanced breast cancer (ABC). Further inspection of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor publications was performed to examine PROMs in the HR+/human epidermal growth factor receptor 2–negative (HER2-) setting. A total of 88 results were identified in the initial search; 32 were included in the final analysis. Among included studies, most (66%) had been published in the last 5 years (2015 to 2020). CDK4/6 inhibitors (38%) were the most common agents reported. No clear standard for PROM use, reporting, or analysis was found. The most common PROMs were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (59%) and the Functional Assessment of Cancer Therapy–Breast (FACT-B; 34%). Important differences, among studies that reported them, ranged from 5 to 10 points for the EORTC QLQ-C30 and 8 points for the FACT-B total score. This review showed that a lack of clear consistency remains for PROM use, reporting, and analysis in phase 3 clinical trials of HR+ ABC. However, HRQOL is of high interest in the literature, including for CDK4/6 inhibitors.

AIM: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients.METHODS: Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored.RESULTS: Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts.CONCLUSIONS: The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer.

OBJECTIVES: Nausea and vomiting (NV) remain common cancer symptoms and frequent side effects of anticancer therapies despite available antiemetics. They can lead to treatment disruption and discontinuation. NV is an important patient reported outcome in oncology. This study aimed to build an item bank for computer-adaptive testing (CAT) based on NV questions in the European Organisation for Research for Treatment of Cancer, Quality of Life for Cancer Patients (EORTC QLQ-C30) questionnaire and complete the first three phases of development as described in the EORTC Quality of Life Group guidelines.DATA SOURCES: The development followed a standard procedure. The three phases include conceptualization and literature search (phase 1); item classification, selection, formulation and rating, and expert evaluations (phase 2); and patient pretesting (phase 3). The literature search resulted in a preliminary list of 115 items. Following classification, formulation, and rating, 21 candidate items adhered to the QLQ-C30 format. Evaluation by experts (n = 11) from five countries and patients (n = 31) pretesting in Denmark, Poland, and the UK lead to a final list of 20 items.CONCLUSION: The selection, development, and refining of NV items have been described. The nature of this testing ensures an initial CAT item bank that after field testing (phase 4) and psychometric analysis is expected to provide a precise and efficient NV measurement while still being comparable to the original QLQ-C30 scale.IMPLICATIONS FOR NURSING PRACTICE: Access to reliable tools that facilitate NV comprehensive assessment is an important issue for nurses caring for patients with cancer. This CAT item bank is meant to support clinical decisions when all phases of testing are completed.