ObjectivesTo identify the information needs of people with advanced cancer, and their carers, to make an informed decision to commence or discontinue parenteral nutrition (PN).MethodsSemi-structured interviews with people who had advanced cancer and were receiving PN, and their informal carers were audio-recorded with consent and transcribed verbatim. Analysis was conducted using a framework analysis approach. Patients were recruited via four hospitals including a cancer centre and intestinal failure units. Carers were recruited via recruiting hospitals, advertisement on social media and support group forums.ResultsInterviews were conducted with five patients and six carers. Five overarching themes were identified: factors affecting the decision: lack of choice and the importance of hope and advocacy, communication and information: whose role is it?, tackling discussions around benefits, risks and challenges of PN, the reality of living with home PN and neglected conversations: stopping PN and advance care planning. Patients and carers suggested essential information provided should include how to recognise complications, what to expect with home PN, and the risks and benefits of PN. They also recommended ways to improve service delivery including identification of the professional responsible for PN, improving communication through multiprofessional meetings and establishing a clear home PN pathway and service specification.ConclusionsThis study has identified information that patients with advanced cancer and their carers need to make decisions around commencing and discontinuing parenteral nutrition. This knowledge can contribute to the development of decision tools to support shared decision-making among patients, carers and healthcare professionals.

The development of the first European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) health-related quality of life (HRQoL) questionnaires contributed to the systematic uptake of HRQoL as an endpoint in cancer clinical trials, and to the measurement of HRQoL for individual assessment in routine care. Following a modular approach, these patient-reported outcome (PRO) measures (PROMs) ensure that both generic and disease-specific issues are assessed, enabling comparison of PROs across groups and studies. The application of a comprehensive and continually refined methodology for developing and updating these PROMs has been crucial in supporting their psychometric and cross-cultural validity, and their continued implementation in clinical research. However, the advancement of measurement science, the more widespread implementation of PROMs, and the significant evolution of anti-cancer therapies over the last decades have highlighted the need to adopt more flexible approaches to PRO assessment to ensure that PROMs remain relevant and fit-for-purpose. The QLG has responded to this call by implementing more tailored PRO measurement approaches through the development and release of the computerised adaptive test (CAT) version of the EORTC QLQ-C30 (i.e., the EORTC CAT Core) and the EORTC Item Library. The EORTC Item Library is an interactive online platform that allows for the creation of customised questionnaires (item lists) from the pool of available items derived from established EORTC QLG PROMs. The aim of this article is to describe the current EORTC QLG approach to PRO measurement in oncology, covering important historical developments and best practice recommendations.

Patient reported outcome measures (PROMs) are an effective method for monitoring cancer patients from diagnosis. We aimed to identify which NHS trusts in England are using PROMs in routine cancer care and for what purpose. A survey of PROM use in routine cancer care was sent to all NHS trusts in England providing cancer services using a freedom of information (FOI) request in May 2024. Responses were analysed descriptively. Survey response rate was 94

ObjectivesThe objective was to map the experiences and needs of patients presenting with symptoms of suspected cancer in the primary care interval (from when they first present to primary care to their first appointment or referral to a secondary or tertiary level healthcare facility).DesignThis was a scoping review.Inclusion criteriaStudies or reports written in English which included primary data on the primary care interval experiences and/or needs of adult patients presenting with new symptoms of suspected cancer were eligible. Studies which only included patients with secondary or recurring cancer, conference abstracts and reviews were excluded. No date limits were applied.MethodsThe Joanna Briggs Institute method for Scoping Reviews guided screening, report selection and data extraction. At least two independent reviewers contributed to each stage. Medline, CINAHL, PsychInfo, Embase and Web of Science were searched and several grey literature resources. Relevant quantitative findings were qualitised and integrated with qualitative findings. A thematic analysis was carried out.ResultsOf the 4855 records identified in the database search, 18 were included in the review, along with 13 identified from other sources. The 31 included studies were published between 2002 and 2023 and most (n=17) were conducted in the UK. Twenty subthemes across four themes (patient experience, interpersonal, healthcare professional (HCP) skills, organisational) were identified. No studies included patient-reported outcome measures. Patients wanted (1) to feel heard and understood by HCPs, (2) a plan to establish what was causing their symptoms, and (3) information about the next stages of the diagnostic process.ConclusionsScoping review findings can contribute to service planning as the cancer diagnostic pathway for symptomatic presentation of cancer evolves. The effectiveness of this pathway should be evaluated not only in terms of clinical outcomes, but also patient-reported outcomes and experience, along with the perspectives of primary care HCPs.

BackgroundNutritional status is compromised long-term following oesophagectomy. Controversy surrounds the optimal route for nutrition support postoperatively and there is wide variation in the use of feeding jejunostomy tubes.MethodsA retrospective service evaluation was conducted for all consecutive adults who underwent oesophagectomy for a cancer diagnosis within a specialist centre between April 2016 and July 2019 (n = 165). Nutritional and clinical outcomes were compared for patients who received jejunostomy feeding (n = 24), versus those who did not (n = 141).ResultsPatients with feeding jejunostomy lost significantly less weight at both 6 and 12 months postoperatively compared to those without jejunostomy (p & LE; 0.001 and p = 0.001, respectively). This remained statistically significant in multiple regression, controlling for age, gender, preoperative tumour staging and adjuvant treatment (p & LE; 0.001 and p = 0.03, respectively). Median length of home enteral feeding was 10 weeks after discharge in the jejunostomy group. We observed minor jejunostomy tube-related complications in four patients (16.7%). Of those readmitted within 90 days of surgery in the non-jejunostomy group, nutritional failure was a factor in 43.2% of these readmissions. "Rescue tube feeding" was required by 8.5% of the non-jejunostomy group within the first postoperative year, including 6.4% within 90 days of surgery.ConclusionsUse of short-term supplementary jejunal feeding in addition to oral intake after hospital discharge is beneficial for maintaining weight after oesophagectomy. We suggest a future randomised-controlled trial to confirm these findings. A retrospective service evaluation compared nutritional and clinical outcomes for patients who received jejunostomy feeding after oesophagectomy versus those who did not. Patients with feeding jejunostomy lost significantly less weight at both 6 and 12 months postoperatively and jejunostomy feeding prevented the need for readmissions with nutritional failure.image Malnutrition is prevalent in patients diagnosed with oesophageal cancer and nutritional status is further compromised following oesophagectomy. There is currently nationwide variation in the use of feeding jejunostomy tubes after oesophagectomy.This study compared clinical and nutritional outcomes to 12 months postoperatively in a cohort of patients who received feeding jejunostomy tubes (n = 24) with those who did not (n = 141).Patients with feeding jejunostomy lost significantly less weight at both 6 and 12 months postoperatively compared to those without jejunostomy (p & LE; 0.001 and p = 0.001, respectively).We suggest a future randomised-controlled trial to confirm our finding that feeding jejunostomy was beneficial for maintaining weight after oesophagectomy, in addition to evaluating its effect on quality of life and body composition.

Objective Shared decision making is important when decisions are preference sensitive, as in incurable cancer. A prerequisite for shared decision making is health literacy, which is essential to facilitate good understanding of an individual's current situation, the decision to be made, and the options available to them. This study sought to learn about the challenges for shared decision making faced by patients with incurable cancer and health literacy difficulties.Methods Semi-structured telephone and video interviews were used to collect data on participants' experiences, decision making, and challenges faced. Study procedures followed health literacy principles, with information offered in various formats to suit individuals' preferences, the use of a verbal consent process, and flexibility in whether interviews were conducted over telephone or video call. Data were analysed using Framework Analysis (Ritchie et al. 2003), with initial verbatim transcription of interviews, iterative development of the analysis framework, indexing using Nvivo 12 software and summarising of the data before systematic categorisation and development of final themes.Results Twenty participants (aged 31-80, of whom 13 male) with a variety of cancers (including breast, central nervous system, gastrointestinal, gynaecological, lung, head and neck, and urological) and experience of a range of treatments were interviewed. Seven themes were identified, including: supportive staff in an imperfect system, additional pressure from COVID-19, in the expert's hands, treatment not so bad, emotional hurdles, accessing information to further understanding and wanting to be a good patient.Conclusion In order to support patients with incurable cancer and health literacy difficulties to become involved in decisions about their care, we must address the emotional, social and informational challenges they face. Recommendations for achieving this include addressing peoples' emotional needs, facilitating control over information, developing a partnership, involving others, and organisational changes.

BACKGROUND:The androgen receptor is a tumour suppressor in oestrogen receptor-positive breast cancer. The activity and safety of enobosarm, an oral selective androgen receptor modulator, was evaluated in women with oestrogen receptor (ER)-positive, HER2-negative, and androgen receptor (AR)-positive disease. METHODS:Women who were postmenopausal (aged ≥18 years) with previously treated ER-positive, HER2-negative, locally advanced or metastatic breast cancer with an Eastern Cooperative Oncology Group performance status of 0-2 were enrolled in a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial done at 35 cancer treatment centres in nine countries. Participants were stratified on the setting of immediately preceding endocrine therapy and the presence of bone-only metastasis and randomly assigned (1:1) to 9 mg or 18 mg oral enobosarm daily using an interactive web response system. The primary endpoint was clinical benefit rate at 24 weeks in those with centrally confirmed AR-positive disease (ie, the evaluable population). This trial is registered with ClinicalTrials.gov (NCT02463032). FINDINGS:Between Sept 10, 2015, and Nov 28, 2017, 136 (79%) of 172 patients deemed eligible were randomly assigned to 9 mg (n=72) or 18 mg (n=64) oral enobosarm daily. Of these 136 patients, 102 (75%) patients formed the evaluable population (9 mg, n=50; 18 mg, n=52). The median age was 60·5 years (IQR 52·3-69·3) in the 9 mg group and 62·5 years (54·0-69·3) in the 18 mg group. The median follow-up was 7·5 months (IQR 2·9-14·1). At 24 weeks, 16 (32%, 95% CI 20-47) of 50 in the 9 mg group and 15 (29%, 17-43) of 52 in the 18 mg group had clinical benefit. Six (8%) of 75 patients who received 9 mg and ten (16%) of 61 patients who received 18 mg had grade 3 or grade 4 drug-related adverse events, most frequently increased hepatic transaminases (three [4%] of 75 in the 9 mg group and two [3%] of 61 in the 18 mg group), hypercalcaemia (two [3%] and two [3%]), and fatigue (one [1%] and two [3%]). Four deaths (one in the 9 mg group and three in the 18 mg group) were deemed unrelated to the study drug. INTERPRETATION:Enobosarm has anti-tumour activity in patients with ER-positive, HER2-negative advanced breast cancer, showing that AR activation can result in clinical benefit, supporting further clinical investigation of selective AR activation strategies for the treatment of AR-positive, ER-positive, HER2-negative advanced breast cancer. FUNDING:GTx.

AIM:Colorectal cancer (CRC) patients need CRC-specific dietary guidance, but often lack access to adequate nutritional information and support. This scoping review identified study interventions, online resources, which have been produced to support nutritional care self-management for CRC patients from diagnosis, through treatment and into survivorship and guidelines to underpin these. METHODS:The review was carried out in accordance with the JBI method for Scoping Reviews. Study interventions, online resources that support the self-management of nutrition and diet in CRC patients were eligible for inclusion, along with CRC-specific guidelines. Searches up to February 2023, were carried out via MEDLINE, CINAHL, PsycInfo, Embase, and Web of Science for published literature and ProQuest Dissertations, Theses Global, TRIP Medical Database, and Google search engines for grey literature. Two reviewers independently screened titles and abstracts, and relevant full texts for inclusion. Data were analysed descriptively. RESULTS:Eight study interventions, 74 online resources and three guidelines specifically aimed at CRC patients were included in the review. Study interventions were heterogenous with respect to duration, whether it was personalized, who supported delivery and which guidelines underpinned the intervention. Three study interventions resulted in improved quality of life and one lengthened survival. A total of 36 (48.6%) online resources were produced by UK charity organizations. Most of the included information was for patients after completing treatment. Specific advice for patients with a stoma was lacking. Some of the online resources provided conflicting advice. The three guidelines explained how dietary adjustments can help address symptoms related to cancer or treatment and two provided more specific guidance on making dietary changes, with specific examples of how to tailor dietary advice to patient needs. CONCLUSION:This scoping review of study interventions, online resources, and guidelines highlighted the need for reliable, detailed, and personalized information to help CRC patients to self-manage their nutritional care.

Purpose The purpose of this systematic review is to better understand access to, acceptance of and adherence to cancer prehabilitation. Methods MEDLINE, CINAHL, PsychINFO, Embase, Physiotherapy Evidence Database, ProQuest Medical Library, Cochrane Library, Web of Science and grey literature were systematically searched for quantitative, qualitative and mixed-methods studies published in English between January 2017 and June 2023. Screening, data extraction and critical appraisal were conducted by two reviewers independently using Covidence™ systematic review software. Data were analysed and synthesised thematically to address the question ‘What do we know about access, acceptance and adherence to cancer prehabilitation, particularly among socially deprived and minority ethnic groups?’ The protocol is published on PROSPERO CRD42023403776 Results Searches identified 11,715 records, and 56 studies of variable methodological quality were included: 32 quantitative, 15 qualitative and nine mixed-methods. Analysis identified facilitators and barriers at individual and structural levels, and with interpersonal connections important for prehabilitation access, acceptance and adherence. No study reported analysis of facilitators and barriers to prehabilitation specific to people from ethnic minority communities. One study described health literacy as a barrier to access for people from socioeconomically deprived communities. Conclusions There is limited empirical research of barriers and facilitators to inform improvement in equity of access to cancer prehabilitation. Implications for Cancer Survivors To enhance the inclusivity of cancer prehabilitation, adjustments may be needed to accommodate individual characteristics and attention given to structural factors, such as staff training. Interpersonal connections are proposed as a fundamental ingredient for successful prehabilitation.

Background The present study aims to summarise current knowledge and identify gaps in knowledge and research regarding experience, decision-making and information needs around parenteral nutrition, among people with advanced cancer, and their carers. Methods This review was informed by previous methods and guidance on conducting and reporting scoping reviews. A literature search was conducted in March 2021 using Embase, Medline, CINAHL, Google and Web of Science to identify studies that examined the experience, decision-making process and information needs of adults with advanced cancer, and their carers, who were making decisions around commencing and discontinuing parenteral nutrition. There were no date limitations, although only papers published in English were included. Results Of the 588 papers identified, 12 papers, all qualitative, met the eligibility criteria. Despite the reported negative aspects of home parenteral nutrition, patients and carers felt the benefits outweighed these. There was variability in whether patients and carers felt involved in decisions around commencing parenteral nutrition. No studies specifically addressed information needs. Conclusions Research is required to explore the information that patients with advanced cancer, and their carers, need to facilitate their decision-making around commencing and discontinuing parenteral nutrition. We recommend the development of processes for obtaining written informed consent from patients commencing parenteral nutrition to ensure that core topics are discussed on initiation, enabling patients and carers to make informed decisions. Additionally, we recommend development of a national framework to inform patients and carers of the whole discharge process on PN from decision-making to discontinuing PN.

Background The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented. Methods Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews. Results Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference. Conclusions Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials. Trial registration ISRCTN27544579, prospectively registered on 22 May 2014

Introduction A gastrostomy tube (GT) may be offered to people living with motor neurone disease (plwMND) to administer food, fluids and medication when eating and drinking become difficult. However, the evidence base for GT benefit is lacking. Patient decision aids (DA) support shared decision making by providing evidence-based information, elucidating personal preferences and checking understanding.1 Methods The three-phased DiAMoND study aimed to co-produce and pilot test a web-based DA to support people with MND deciding whether to have a GT. Participants included plwMND, carers and healthcare professionals (HCPs). In Phase 1, the content and design of the DA was informed by semi-structured interviews, literature reviews and prioritisation survey. In Phase 2, the prototype DA was tested with users and developed iteratively with feedback from surveys and 'think-aloud' interviews. In Phase 3 the DA was evaluated using validated questionnaires.2–5 Results In total, 16 plwMND, 16 carers and 25 HCPs took part in Phases 1 and 2. Interviews and the literature review generated a prioritisation survey with 82 content items. Seventy-seven percent (63/82) of the content of the DA was retained. A prototype DA, which conforms to international DA standards1, was produced and improved during Phase 2. In Phase 3, 17 plwMND completed questionnaires after using the DA. Most plwMND (94%) found the DA completely acceptable and would recommend it to others in their position, had no decisional conflict (88%), and were well prepared (82%) and satisfied with their decision making (100%). Conclusion Gastrostomy Tube Is it for me? was co-produced with stakeholders and found to be acceptable, practical and useful to plwMND. It is freely available from the MND Association website. The DA is a valuable tool to support plwMND and HCPs through the GT shared decision making process. References International Patient Decision Aid Standards (IPDAS) (Accessed June 23, 2022, at www.ipdas.ohri.ca.) O'Connor A. User Manual – Stage of Decision Making 2000 [updated 2003] [Available from: https://decisionaid.ohri.ca/docs/develop/user_manuals/um_stage_decision_making.pdf]. Ferron Parayre A, Labrecque M, Rousseau M, Turcotte S, Légaré F. Validation of SURE, a four-item clinical checklist for detecting decisional conflict in patients. Medical Decision Making : An International Journal Of The Society For Medical Decision Making. 2014;34(1):54–62. C Bennett, ID Graham, E Kristjansson, SA Kearing, KF Clay, O'Connor A. Validation of a preparation for decision making scale. Patient Educ Couns. 2010;78(1):130–3. Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, et al. patient satisfaction with health care decisions:the satisfaction with decision scale. Medical Decision Making. 1996;16(1):58–64.

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, sideeffects 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. (c) 2022 The Authors. Published by Elsevier Ltd.

Domestic abuse is a worldwide public health and social issue which impacts the health and wellbeing of those experiencing abuse and their families. People living with a life-limiting illness are at increased risk of domestic abuse because they are often frail, isolated, and dependent on others. Little is known about domestic abuse and the coexistence of life-limiting illness and existing support for those experiencing or at risk of abuse. A scoping review was conducted to identify factors that shape and characterise experiences of adults with a life-limiting illness affected by domestic abuse and the health and social care practitioners and other organisations that support them. The Joanna Briggs Institute (JBI) methodology and checklist for Preferred Reporting Items for Systematic Reviews and Meta Analyses-Extension for Scoping Reviews (PRISMA-ScR) were applied. Five databases were systematically searched from 2000 to 2021: MEDLINE; CINAHL; PsycINFO; Social Sciences Citation Index (Web of Science); and ProQuest Dissertations and Global. Twenty-one papers met the inclusion criteria. Most studies were conducted in North America, with female participants living with cancer, and conducted in health and community settings. There were no studies involving third sector organisations. A range of abusive behaviours was reported resulting in missed medical appointments, delays in screening leading to late diagnosis, and palliative rather than curable treatment. Abuse also impacted on the physical, emotional, and psychological wellbeing of the person experiencing the abuse, which increased stress levels and could have a detrimental effect on their health. Identifying domestic abuse within the context of life-limiting illness was reported to be challenging for health and social care professionals, as was responding to and managing a disclosure. Further research is needed to address existing knowledge in order to inform policy and practice to identify and manage domestic abuse where it coexists with life-limiting illness.

Patients with incurable cancer often face difficult decisions about their care. Shared decision making (SDM) can help people make the decisions that are right for them, by supporting understanding and ensuring their priorities are considered. Essential for this is health literacy (HL) - the personal competencies and situational resources needed for people to process information to make decisions. This study sought to understand the barriers to SDM in the context of HL from the perspective of patients and clinicians, and consider how they may be overcome. This mixed methods study comprised: 1) semi-structured interviews with patients with incurable cancer and suspected HL difficulties, identified by clinicians from 2 district hospitals; and 2) an online survey of NHS healthcare professionals caring for patients with incurable cancer. Interview data were analysed using the Framework Approach to identify important and recurrent themes. For the survey, a descriptive analysis was carried out for the quantitative data, and thematic analysis for the qualitative data. Twenty-one interviews were conducted. Patients had a range of diagnoses and had received various treatments. Themes related to experiences (supportive staff in an imperfect system, additional pressure from COVID-19, in the expert’s hands, treatment not so bad) and barriers to SDM (emotional hurdles, accessing and understanding information, wanting to be a good patient). Survey participants (N=70) included doctors, nurses, and a pharmacist. Views towards SDM ranged from those who aim to ‘always’ use it, to those who feel its use should be limited. Patient, clinician, and situational barriers were identified. Key challenges for SDM include the persistence of paternalistic clinician-patient roles, dealing with emotional hurdles, and practical issues. There are socio-cultural, emotional and system barriers to SDM in incurable cancer for those with HL difficulties. Addressing this combination of issues will be important to fully embed its use in practice. Recommendations to improve SDM range from large scale policy changes to provision of easily accessible and understandable patient information and decision aids in a variety of formats.

Background We aimed to create a questionnaire to assess the health-related quality of life including functioning, symptoms, and general health status of adult patients with current or previous COVID-19. Here, we report on Phase I and II of the development. Methods Internationally recognized methodology for questionnaire development was followed. In Phase I, a comprehensive literature review was performed to identify relevant COVID-19 issues. Decisions for inclusion, exclusion, and data extraction were completed independently in teams of two and then compared. The resulting issues were discussed with health care professionals (HCPs) and current and former COVID-19 patients. The input of HCPs and patients was carefully considered, and the list of issues updated. In Phase II, this updated list was operationalized into items/questions. Results The literature review yielded 3342 publications, 339 of which were selected for full-text review, and 75 issues were identified. Discussions with 44 HCPs from seven countries and 52 patients from six countries showed that psychological symptoms, worries, and reduced functioning lasted the longest for patients, and there were considerable discrepancies between HCPs and patients concerning the importance of some of the symptoms. The final list included 73 issues, which were operationalized into an 80-item questionnaire. Conclusion The resulting COVID-19 questionnaire covers health-related quality of life issues relevant to COVID-19 patients and is available in several languages. The next steps include testing of the applicability and patients' acceptability of the questionnaire (Phase IIIA) and preliminary psychometric testing (Phase IIIB).

Background: 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 (PROMs) 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: This study included adults undergoing cancer treatment in Europe and the USA. Patients participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side effects, and impacts on health-related quality of life (HRQoL). Thematic analysis of interview transcripts was conducted, and similarities across cancer types, disease stages and countries or languages were explored. Findings: Interviews with 113 cancer patients (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. Interpretation: In this diverse and contemporary patient sample, QLQ-C30 items were widely understood across language versions and relevant to patients across cancer types and disease stages. Evidence of content validity is in relation to context of use; users should consider if assessment of additional concepts is warranted. The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden, and HRQoL in patients with localised-to-advanced cancer.Funding Information: This work was supported by the EORTC Quality of Life Group [Grant number 006-2015]. Declaration of Interests: The following authors declare no competing interests: Andrew Bottomley, Neil K Aaronson, Deborah Fitzsimmons, Mogens Groenvold, and Sally Wheelwright . Authors Colin Johnson, Krzysztof Tomaszewski, Michael Koller, Monica Pinto, Simone Oerlemans, and Heike Schmidt’s respective institutions were provided funding from the EORTC Quality of Life Group to conduct the research described in this manuscript. Authors Jane R Wells, Chelsea Finbow, Elizabeth Exall, Chloe Tolley, and Laura Grant are or were at the time of the study employees of Adelphi Values Ltd. Adelphi Values Ltd was provided a grant from the EORTC Quality of Life Group to conduct the research described in this manuscript and to develop this manuscript. Adelphi Values Ltd provides consultancy for a variety of pharmaceutical companies. Author Kim Cocks is an employee of Adelphi Values Ltd. However, the role of Principal Investigator on this study was not funded through the EORTC Quality of Life Group grant. Kim Cocks has received consulting fees from Endomag Ltd. Author Galina Velikova’s institution was provided funding from the EORTC Quality of Life Group to conduct the research described in this manuscript and other research. Galina Velikova also declares that her institution has grants/contracts with Breast Cancer Now, Pfizer, and IQVIA. Galina Velikova discloses relationships with Novartis, Eisai, Seattle Genetics, Sanofi Advisory Board, and Roche Ester Steering Committee.Ethics Approvals: Ethical approval in the US was obtained from Copernicus Independent Review Board (IRB), approval was granted before any research activities began and the IRB tracking number is: ADE1-18-151. UK: Ethical approval in the UK was obtained from the Integrated Research Application System (IRAS) and the Health Research Authority (HRA), approval was granted before any research activities began and the IRAS project ID is: 211835 and Research Ethics Committee (REC) reference is: 17/SC/0305. Italy: Ethical approval in Italy was obtained from Comitao Etico IRCCS Pascale at the Istituto Nazionale per lo Studio e la Cura dei Tumori and approval was obtained before the study began. Germany:The ethical approval was applied for at the ethics commitee of the Medical Faculty of the Martin Luther University Halle Wittenberg.The final ethical approval was received Nov. 22 2018; Identification number: 2018-143Ethical approval in Germany (site Regensburg) was obtained from Ethikkommission an der Universität Regensburg and approval was obtained before the study began. Poland: Ethical approval in Poland was obtained from the Jagiellonian University Medical College Bioethical Commission and approval was obtained before the study began. The registry number for the approval was: KBET/187/B/2017.

ObjectivePersonalised care requires the identification of modifiable risk factors so that interventions can be implemented rapidly following a gynaecological cancer diagnosis. Our objective was to determine what pre-treatment factors are associated with quality of life (QOL) at baseline (pre-treatment) and 12 months.Methods1222 women with a confirmed diagnosis of endometrial, ovarian, cervical or vulvar cancer from 82 UK NHS hospitals agreed to complete questionnaires at baseline, three and 12 months. Questionnaires included measures of QOL, health, lifestyle, support and self-management. The primary outcome measure was QOL as measured by Quality of Life in Adult Cancer Survivors (QLACS). Sites provided clinical data at baseline, six and 12 months. Linear regression models were constructed to examine the association between baseline characteristics and QOL outcomes.ResultsQOL declined between baseline and 3 months, followed by an improvement at 12 months. Baseline (pre-treatment) factors associated with worse QOL at both baseline and 12 months were depression, anxiety, living in a more deprived area and comorbidities which limit daily activities, whereas higher self-efficacy and age of 50+ years were associated with better QOL.ConclusionsDepression, anxiety and self-efficacy are modifiable risk factors that can impact on QOL. Screening for these, and assessment of whether comorbidities limit daily activities, should be incorporated in a holistic needs assessment and interventions to improve self-efficacy should be made available. Care can then be personalised from the outset to enable all women with a gynaecological cancer the opportunity to have the best QOL.

Aim Depression experienced by people with colorectal cancer (CRC) is an important clinical problem affecting quality of life. Recognition of depression at key points in the pathway enables timely referral to support. This study aimed to examine depression before and 5 years after surgery to examine its prevalence and identify determinants. Method The ColoREctal Wellbeing (CREW) study is a prospective UK cohort study involving 872 adults with nonmetastatic CRC recruited before surgery with curative intent. Questionnaires completed before surgery and 3, 9, 15, 24, 36, 48 and 60 months after surgery captured socio-demographics and assessed depression (Centre for Epidemiologic Studies Depression Scale, CES-D) and other psychosocial factors. Clinical details were also gathered. We present the prevalence of clinically significant depression (CES-D >= 20) over time and its predictors assessed before and 2 years after surgery. Results Before surgery, 21.0% of the cohort reported CES-D >= 20 reducing to 14.7% 5 years after surgery. Presurgery risk factors predicting subsequent depression were clinically significant depression and anxiety, previous mental health service use, low self-efficacy, poor health, having neoadjuvant treatment and low social support. Postsurgery risk factors at 2 years predicting subsequent depression were clinically significant depression, negative affect, cognitive dysfunction, accommodation type and poor health. Conclusion Depression is highly pervasive in people with CRC, exceeding prevalence in the general population across follow-up. Our findings emphasize the need to screen and treat depression across the pathway. Our novel data highlight key risk factors of later depression at important and opportune time points: before surgery and at the end of routine surveillance. Early recognition and timely referral to appropriate support is vital to improve long-term psychological outcomes.