The European Organisation for Research and Treatment of Cancer (EORTC) questionnaires are some of the most widely used patient-reported outcome measures (PROMs) for health-related quality of life assessment in oncology. The EORTC Item Library is an online platform comprising all EORTC PROMs that enables the creation of customised questionnaires (item lists). To characterise and better understand the breadth of functioning, disability and health coverage within the EORTC Item Library, this study aimed to link and analyse its content using the International Classification of Functioning, Disability and Health (ICF). A team of reviewers applied the most recent ICF linking rules to map the items currently included in the EORTC Item Library. Descriptive analysis was used to summarise the content covered in ICF categories and concepts coded as not covered or not definable. The 1076 EORTC items covered 1860 concepts overall, with most (n = 1641, 88.2

There is a need for a comprehensive summary of qualitative research on the health-related quality of life (HRQoL) of people with advanced cancer requiring palliative care. We aim to systematically review qualitative studies on outcomes, needs, experiences, preferences, concerns and HRQoL of people in Europe with advanced cancer requiring palliative care over the last decade. Protocol registered ( www.crd.york.ac.uk/PROSPERO , CRD42024575065). The search was conducted in PubMed and Scopus, from 2013 onward. Inclusion criteria: qualitative studies addressing constructs related to the HRQoL of adults with cancer requiring palliative care in Europe. Abstracts and full texts were reviewed, data extracted, and risk of bias assessed independently by two researchers. A thematic analysis stratified by study objective was performed, grouping the emerging themes into categories (primary outcome). Of 18,256 articles identified, 20 fulfilled the inclusion criteria: 10 studies with a generic objective (whole palliative process or end-of-life phase), and 10 with specific focuses. Five categories (35 themes) emerged from the studies with generic focuses: ‘Psychological Function’ (n = 15), ‘Clinical Management’ (n = 8), ‘Symptoms and Physical Function’ (n = 6), ‘Social Function’ (n = 5), and ‘End-of-life’ (n = 1). Themes from the 7 studies focusing on treatment, services, and self-management also fitted into these categories, adding ‘Spiritual Well-being’. These findings emphasise the predominance of the psychological function domain in cancer patients requiring palliative care, including cancer-related anxiety and distress, coping mechanisms, control and decision-making, and fearing and expecting death. Additionally, clinical management unmet needs were identified in health care, information and communication, and end-of-life settings (home vs. hospital). Differences across Europe in access to palliative care can affect the symptoms suffered by patients with advanced cancer. Many questionnaires measuring quality of life among oncology patients in palliative care failed to address the whole range of their concerns. Through a systematic review of the literature, we identified 20 studies where these patients express their needs, experiences, preferences, and the impact on their quality of life. Beyond the traditional physical dimension, our results highlight the predominance of the psychological and spiritual dimensions among people in Europe with advanced cancer requiring palliative care over the last decade. Also, these patients often comment the importance of clinical management, which usually is not included in quality of life instruments, to consider the way the healthcare professionals address and inform them of each step, and to support shared decision-making, including where to spend their end-of-life stage: at home or in a hospital. New questionnaires to measure correctly the many dimensions identified by patients with advanced cancer will allow the healthcare systems in European countries improve their understanding and allow for policy changes to better support them at this last stage of their lives.

Cancer remains a leading cause of morbidity and mortality worldwide. Given its substantial burden, quality of life has become a key outcome in cancer care and research. Patient-reported outcome measures (PROMs) are commonly used to assess quality of life. Although qualitative research is essential for establishing PROM content validity, patient narratives are less often collected and analysed systematically once PROMs are implemented. Adding open-ended responses to quantitative PROM data may provide policy-relevant insights into what patients themselves prioritise. This study has aimed to identify the factors that people living with or beyond cancer across Europe perceive as having the greatest impact on their quality of life. Following a pan-European validation study of the newly developed EUonQoL-Kit – a set of questionnaires designed to assess the quality of life of people living with or beyond cancer in Europe – the responses to the final open-ended question “Having completed the questionnaire, what do you feel most impacts your quality of life?” were collected. Responses underwent qualitative thematic analysis using a coding framework iteratively developed and interpreted by researchers and people with lived experience of cancer involved as ‘co-researchers’. Of the 4,284 cancer patients and survivors participating in the EUonQoL-Kit validation study, 3,350 (78.2%) provided a response to the final open-ended question. Factors perceived as having the greatest impact on quality of life were categorised into 23 distinct themes, covering six overarching domains: Physical health, Psychological wellbeing, Social health, Overall health, Healthcare experience and Environment. The most frequently reported factors included physical symptoms, overall health, relationships and connectivity, emotions and feelings, and impact of care pathway. This study provides a comprehensive overview of the factors that impact quality of life most in people living with or beyond cancer across Europe. Combining structured PROMs with open-ended patient input may support more patient-centred quality of life measurement and interpretation and help align care and policy priorities with what matters most to patients.

BACKGROUND/OBJECTIVES:Simple frailty assessments, such as the clinical frailty scale (CFS), are prognostic for worse outcomes in older adults with cancer and could support treatment decision-making. This interview study aims to explore clinicians' experiences of using simple frailty assessments in oncology, including the impacts on patient care and barriers and facilitators to successful implementation. METHODS:Semi-structured individual interviews were conducted with clinicians at three UK sites that had implemented CFS screening in lung cancer clinics as part of a national pilot, to explore how frailty assessments are applied and are impacting care. Purposive sampling targeted a range of professionals involved in assessing frailty and making treatment decisions. Recordings were transcribed verbatim and analysed thematically. RESULTS:Ten clinicians participated, and four main themes were identified. 'Assessing fitness and frailty' explores the central role of performance status (PS), as well as its limitations, and what frailty assessments add. 'Scoring and interpreting CFS' describes the ease and relative yield of CFS use, particularly for patients with 'borderline' PS scores (e.g., PS 1-2 or 2-3), and the importance of contextual interpretation. 'Role of frailty and impacts of assessment' highlights how frailty assessments can enhance patient-centered care and support, and clinical and shared decision-making, with potential for streamlined care and system-level benefits. 'Barriers and facilitators to implementation' are described, including time, culture, guidance, and training, with recommendations provided. CONCLUSIONS:Assessing frailty has wide-ranging potential benefits for patients, oncology teams, and the wider system, but barriers must be overcome. Specific recommendations are provided to support the routine implementation of frailty assessments, which is a key step towards the benefits of frailty-informed care being realised at scale.

BACKGROUND:Patient-reported outcome (PRO) item libraries support flexible PRO assessment in cancer research by facilitating the development of customized item lists. However, little is known about the use of item lists in clinical research. This systematic review addresses this by assessing utilization of PRO item libraries and lists in oncology research. METHODS:A systematic review of MEDLINE, Embase, and CINAHL identified cancer studies using PRO item libraries to develop item lists, regardless of study design, published between October 2021 and September 2025. Key features of item library usage were extracted and analyzed descriptively. RESULTS:A total of 78 studies were included (25 trials and feasibility, 53 observational). The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events system was frequently used (49 of 78), and symptom assessment was the most common application (63 of 78). Item lists were implemented across different settings including novel treatments (19 of 78) and rare cancers (15 of 78). Most item lists were derived from a single PRO item library (72 of 78). In some studies, there was additional customization such as item wording changes (5 of 78) or addition of items adapted from the item library (9 of 78). Item selection methods included literature (32 of 78), patient involvement (8 of 78) and consultation with health-care professionals (11 of 78). Many studies (40 of 78) did not report methods used. CONCLUSIONS:PRO item libraries are increasingly used to create customized item lists in oncology research, primarily for symptom assessment. However, reporting practices for methods used are inconsistent, highlighting the need for standardized guidelines for reporting PRO item lists in clinical trials and routine care to improve transparency, reproducibility, and quality.

1 Background: The optimal dose of radiotherapy (RT) in advanced anal squamous cell carcinoma (ASCC) is uncertain. Cure rates need to improve, but higher dose RT may result in significant morbidity. Methods: PLATO ACT5 is a seamless pilot/phII/phIII prospective, multi-centre, 3-arm RCT investigating dose-escalated intensity modulated radiotherapy (de-IMRT) with chemotherapy in patients (pts) with T3/4N0 and TanyN+ ASCC. Primary outcome is 3-year locoregional failure (LRF). We report planned 6-month endpoints: acute toxicity (CTCAEv5), treatment compliance, radiological and clinical complete response rates (cCR) and patient reported outcomes (PROs; EORTC-QLQ C30 and ANL27). Pts were randomised 1:1:1 in 28 fractions to standard dose IMRT (sd-IMRT; 53.2Gy), de1-IMRT (58.8Gy) or de2-IMRT (61.6 Gy) with concurrent mitomycin 12mg/m2 day (D) 1 & capecitabine (CAP) 825mg/m2 BD on RT days or 5FU 1000mg/m2 D1-4 & D29-32. 459 pts including 10% drop out were required to compare each experimental arm against sd-IMRT for 3-year LRF-free survival. Results: 463 pts were recruited from 34 UK sites (sd-IMRT n=154; de1-IMRT n=155; de2-IMRT n=154) between Feb 2017 – Aug 2023. 82% received CAP RT and 18% received 5FU RT. Pts characteristics were balanced across 3 arms: Overall median age was 62 years (range 29-81); 73% ECOG 0; 73% female; 30% T4; 45%/18%/21% N1/2/3 respectively; 21% required pre-RT stoma; 1.5% HIV positive. ≥G3 acute toxicity was reported in 57% (sd-IMRT; n=90), 56% (de1-IMRT n=86) and 58, and at 6 mo 19 patients (5/5/9 respectively) reported ≥G3. 460 completed per protocol RT. RT interruptions: sd-IMRT n=40 (26.1%), de1-IMRT n=33 (21.4%), de2-IMRT n=39 (25.7%) of which 25% were due toxicity. 70 (36%) had CAP reduction/omission (sd-IMRT n=13/50; de1-IMRT n=12/47 de2-IMRT n=39/9 respectively); the majority were due to toxicity (46-58%). 6 mo cCR: (MRI TRG 1&2 with no visible T2 weighted pelvic lymph nodes) are: sd-IMRT =100 (65%); de1-IMRT =103 (67%); de2-IMRT= 101 (66%). For PROs, there was a similar large deterioration in pain, fatigue, bowel function, quality of life, physical, role and social function at the end of CRT across all arms which resolved to baseline by 6 months in all arms. Conclusions: Dose escalation has similar toxicity, but does not improve early outcomes. Further stage stratification and novel biology approaches for personalisation are needed. Clinical trial information: ISRCTN88455282.

To identify and synthesize evidence from European qualitative studies on cancer-related quality of life outcomes, needs, experiences, preferences, and concerns of people undergoing cancer treatment in the last decade. Systematic review ( https://www.crd.york.ac.uk/PROSPERO , CRD42024575065) of European studies using qualitative methodology, assessing constructs related to HRQoL, and involving adults receiving cancer treatment. The search was performed in PubMed and Scopus from January 2013 to July 2024. Titles, abstracts, and full texts screening, data extraction and risk of bias assessment were conducted independently by two researchers. The main outcomes were the themes reported in each study. The thematic analysis was performed by organizing the themes of the studies into categories. Out of 18,256 articles initially identified, 36 met the inclusion criteria: 21 with generic and 15 with specific objectives. Five categories encompassing 110 themes were identified from the generic studies: Psychological Function (n = 41), Clinical Management (n = 26), Symptoms and Physical Function (n = 18), Social Function (n = 16), and Life Disruption (n = 9). Eleven studies with specific objectives focused on clinical management with all their themes fitting within the categories identified in the generic studies. Results showed the predominance of psychological function and clinical management themes. Symptoms and physical function, social function, and life disruption maintained their importance within the classical HRQoL framework. The emergence of clinical management is consistent with the growing patient-centered care approach, suggesting the need to integrate this content into the evaluation of patients undergoing cancer treatment. Limitations: most European countries were not represented, and publication bias could hide traditional domains.

Background Cancer is a leading cause of death in Europe, and it has a major impact on the quality of life of those affected by it. Quality of life is a multifaceted concept affected by a range of factors, namely individual, organisational, and national health system factors. Despite existing research on individual and organisational aspects, little is known about the association between health system factors and quality of life. Therefore, the aim of this study is to explore the health system factors that relate to the quality of life of people with (a history of) cancer and to identify potential gaps in literature.Methods We conducted a rapid review to gain insight into what is known in scientific literature regarding health system factors that are related to the quality of life of people with (a history of) cancer. We complemented our findings with a broad search in various grey literature databases.Results The rapid review included 31 studies, which were supplemented by six health policy reports and one book chapter. Based on the review of scientific and grey literature, we constructed a list of ten health system factors that may relate to the quality of life of people with (a history of) cancer.Conclusions We compiled a list of ten health system factors that may relate to the quality of life of people with (a history of) cancer. Seven factors were identified from and described in scientific literature. Three factors, namely 'policy and vision', 'research and innovation', and 'quality of care delivery', were identified in grey literature. The relation of these health system factors needs to be studied further to better understand what may impact on the quality of life of people with (a history of) cancer.

The global cancer burden is expected to increase dramatically in the coming years, providing considerable difficulties to healthcare systems around the world. While clinical practice frequently focuses on physical symptoms, there is a growing awareness that integrated, patient-centered care, particularly for patients at the end of life (EoL), can be critical for their wellbeing by addressing all aspects of their individual needs. This paper focuses on the essential role of spirituality as a component of quality of life across the EoL trajectory. Assessment of spiritual needs may have clinical value by providing patients with greater self-understanding and autonomy, allowing clinicians to propose humanized and targeted interventions, and guiding healthcare systems in optimizing resource allocation and economic sustainability. Despite its relevance, spiritual care is under-integrated into standard practices due to institutional barriers such as workload, insufficient staff training, and cultural values. To address these gaps, this paper presents the EUonQoL project as a model for developing culturally adapted, patient-centered assessment toolkits. This perspective argues that a comprehensive evaluation of spiritual wellbeing might be regarded as a therapeutic goal to ensure that end-of-life treatment matches with the individual's real priorities and needs.

Introduction Approximately 5-10% of rectal cancer diagnoses are locally advanced (LARC) at presentation and between 4 and 8% recur locally after initial treatment, locally recurrent rectal cancer (LRRC). For patients diagnosed with LARC/LRRC pelvic exenteration (PE) may be potentially curative, but is likely to impact on subsequent quality of life (QoL). To make optimal decisions about their treatment options patients need high quality detailed comprehensible information. To date there are no validated patient decision aids (PtDA) to facilitate the process of shared decision making (SDM) for PE patients. The aim of this study was to develop a PtDA in line with international minimum standards. Methods and analysis A national, multi-centre mixed methods study was designed in keeping with guidance from the International Patient Decision Aids Standard (IPDAS). Ethical approval was obtained. A PtDA was developed by a multidisciplinary committee of clinicians and patient advocates using Agile Cycle Development (ADM). Content was informed by literature review and qualitative patient and clinician interviews. Face validity and field testing were undertaken using mixed-methods of interviews and questionnaires; QQ-10, EORTC PATSAT-C33 and Preparation for Decision-Making Scale (Prep-DM). Results Six sprint cycles were used to develop the content of the PtDA. Qualitative interviews were undertaken with 19 patients and 9 clinicians resulting in 50 changes. Mean scores for value and burden were 89% (SD=12.1) and 8% (SD=8.5), respectively, suggesting high value and low burden for most patients. PtDA use resulted in improved satisfaction in all domains (p<0.05). Pre and post implementation Prep-DM score was 66.8% (SD=11.8) and 91.5% (SD=8.9%), respectively (p<0.001). Discussion This validated PtDA supports SDM for patients considering PE. A future study on implementation once the PtDA is used in routine practice will determine any further barriers to implementation.

Precision oncology relies on access to high-quality data for increasingly smaller patient subgroups. The international atomCAT consortium investigates the potential of federated learning to support this, using anal cancer as a rare cancer exemplar. Here, we show that federated multivariable Cox models trained across 14 centres (1428 patients) and externally validated in two additional centres (277 patients) achieve consistent calibration and discrimination during leave-one-centre-out and external validation (c-indices 0.68-0.79). Lower T stage, absence of nodal involvement, smaller tumour volume, female sex, younger age, and mitomycin- or cisplatin-based chemotherapy are associated with improved overall survival. Lower T stage, smaller tumour volume, and female sex are associated with improved locoregional control, while absence of nodal involvement and smaller tumour volume are associated with better freedom from distant metastases. These findings demonstrate that federated learning enables robust, privacy-preserving prognostic modelling for rare cancers using real-world data, supporting international collaboration without data sharing.

Purpose The European Oncology Quality of Life (EUonQoL) project aims to develop a questionnaire toolkit (EUonQoL-Kit) to assess the quality of life (QoL) of cancer patients and survivors across Europe. Methods The EUonQoL-Kit development used mixed-methods and a co-design approach. Data was collected in six countries (Denmark, France, Germany, Italy, Netherlands and UK). The target populations were patients in active treatment (A), survivors (B) and patients requiring palliative care (C). A review of existing QoL theoretical models produced an initial EUonQoL conceptual framework. Semi-structured interviews and a Delphi survey evaluated/modified the framework. Existing validated items were used to construct the toolkit, including Computer Adaptive Testing (CAT), where available. A usability study evaluated EUonQoL-Kit.v1. Data triangulation and consensus methodology guided EUonQoL-Kit.v2. Results The initial conceptual framework covered four multi-dimensional domains: physical, social and overall health, and psychological wellbeing. The interviews and Delphi survey included 75 and 155 participants, respectively. The domain ‘healthcare experience’ was identified and included in the framework. EUonQoL-Kit.v1 resulted in three static questionnaires, one for each target population (n items- A=75; B=67; C=79). Following usability testing with 53 participants, EUonQoL-Kit.v2 was produced via a multi-stakeholder consensus development panel, creating a shortened version (n items- A=50; B=50; C=44). Dynamic versions of these questionnaires were developed using the EORTC CAT Core system. Conclusions EUonQoL-Kit is a novel toolkit developed to assess QoL across the cancer continuum and inform health policy within Europe. Its psychometric properties are currently being evaluated using data collected on more than 4200 patients across 32 countries.

INTRODUCTION:Despite advancements in adverse events (AEs) reporting, discrepancies often arise between clinician-assessed and patient-reported symptomatic AEs, including in non-small cell lung cancer (NSCLC) trials. This study investigates the extent to which patient-reported questionnaires, particularly the EORTC Questionnaire - Core (QLQ-C30) and the lung cancer-specific module (QLQ-LC29) capture patient-reported symptomatic AEs in systemic treatments for NSCLC. METHODS:A systematic comparison was conducted between symptomatic AEs reported in publicly available Summary of Product Characteristics (SmPC) of systemic NSCLC treatments and patient-reported outcomes captured by the EORTC QLQ-C30 and QLQ-LC29. AEs classified as very common (≥10%) or common (1%-10%) were included. A structured mapping exercise was undertaken to identify overlaps and gaps between symptomatic AEs captured by SmPC and EORTC questionnaires. RESULTS:We analysed 38 systemic treatments and found that the EORTC QLQ-C30 and QLQ-LC29 effectively capture (very) common symptomatic AEs such as diarrhea, nausea and vomiting, pain and skin problems, which are reported in over 75% of SmPCs. A total of 62 symptomatic AEs identified were not captured by the EORTC measures. The majority (58.1%) of these were only reported once and only two symptomatic AEs were reported in >50% of SmPCs: oedema(65.8%) andpyrexia(57.9%). These AEs are well-covered in the EORTC item library. CONCLUSIONS:This study highlights the need for a dual approach to AE reporting in clinical trials that combines clinician assessments with patient-reported outcomes. It also demonstrates the ability of the EORTC QLQ-C30 and QLQ-LC29 questionnaires to capture patient-reported common symptomatic AEs, with the addition of an item list from the EORTC Item Library to capture missing symptomatic AEs. Future research should concentrate on optimizing the integration of these tools to ensure that a broad spectrum of symptomatic AEs is captured, ultimately supporting the understanding of treatment impact on patient health and quality of life.

PURPOSE:The Personalising Radiotherapy Dose in Anal Cancer (PLATO) platform was designed to evaluate risk‑adapted dose optimisation for anal squamous cell carcinoma (ASCC). A key secondary objective was to assess the impact of tailored treatment on patient‑reported outcomes (PROs), using the EORTC QLQ‑ANL27, the first anal cancer-specific validated PRO. METHODS:PLATO comprises three integrated trials: ACT3 (adjuvant chemoradiotherapy vs observation following local excision of T1N0/x anal margin tumours), ACT4 (reduced‑ vs standard‑dose chemoradiotherapy for T1/2 ≤ 4 cmN0/x ASCC), and ACT5 (three dose‑escalated chemoradiotherapy regimens for T3/4 or TanyN + disease). PROs (EORTC QLQ‑C30, QLQ-ANL27) were collected at baseline, end of treatment, 6-weeks, 6, 12, 24 and 36-months. Descriptive analyses to 6-months defined clinically relevant change as > 10‑point differences in mean scores. RESULTS:Between 1/2/2017-31/8/2023, 709 patients were recruited across 36 UK sites; 706 formed the mITT population (PRO consent 98.9 %; 86.0 % completion at 6-months). ACT5 patients reported markedly worse function and symptom scores at baseline than ACT3 and ACT4. All treated groups showed large declines at end of treatment, with improvement to baseline by 6-months for most issues; however, ACT5 participants continued to report residual deficits for bowel function compared with ACT3/4 cohorts. Poorer sexual function was reported in the ACT4 standard‑dose and ACT5 arms at 6-months, with interpretation of ACT3 sexual function limited by small numbers. CONCLUSION:PLATO demonstrates the feasibility of risk‑adapted radiotherapy dosing, with excellent PRO compliance. Most quality-of-life deficits improved by 6-months, although persistent impairments remained in ACT5 patients. Follow‑up to 36-months will further define late effects.

BACKGROUND:Total mesorectal excision (TME) is the standard treatment for most early-stage and intermediate-stage rectal cancer but can cause substantial perioperative morbidity, functional impairment, and reduced quality of life. We assessed whether long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT) could increase organ preservation and reduce surgery, toxicity, and quality-of-life harms without compromising oncological outcomes. METHODS:STAR-TREC is an international, multicentre, open-label, parallel-group, randomised, phase 2/3 trial in five European countries. Eligible patients were aged 16 years or older in the UK or aged 18 years or older elsewhere, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and rectal adenocarcinoma (≤40 mm staged as mrT1-T3bN0). In phase 2, participants were randomly assigned (1:1:1) to LCCRT-based organ preservation (LCCRT-OP; 50 Gy in 25 fractions plus oral capecitabine 825 mg/m2 twice daily), SCRT-based organ preservation (SCRT-OP; 25 Gy in five fractions), or primary TME. Phase 2 assessed feasibility, with recruitment at months 12 and 24 as the primary endpoint and feasibility thresholds of four or more and six or more randomisations per month, respectively. Phase 3 adopted a partially randomised patient-preference design, allowing participants to choose either organ preservation or TME. Participants that chose organ preservation were randomly assigned (1:1) to receive LCCRT-OP or SCRT-OP using centralised, computer-generated assignment, with stratification by country and MRI T category (≤T3a vs T3b) using minimisation. The phase 3 primary endpoint was organ-preservation 30 months after treatment initiation, defined as absence of TME, stoma, or local recurrence, which was assessed in the modified intention-to-treat population, which included participants in phase 2 and phase 3. After a planned interim analysis of unmasked phase 2 data, the trial steering committee and independent data monitoring committee recommended reporting a 12-month, modified intention-to-treat analysis of implementation outcomes for participants recruited before Aug 8, 2023. This study is registered with ISRCTN (14240288) and is closed. FINDINGS:Between June 14, 2017, and April 8, 2024, 503 participants were enrolled at 37 sites. Phase 2 enrolled 120 participants, with recruitment rates of three and six participants per month at months 12 and 24, respectively. Overall, 12-month TME-free survival was 60% (47 of 78 participants). After phase 3 recruitment ended, interim analysis of unmasked phase 2 data showed an early TME-free survival benefit with LCCRT versus SCRT (12-month median TME-free survival not reached [95% CI not reached-not reached] vs 7·6 months [95% CI 6·4-not reached]; hazard ratio [HR] 3·7 [95% CI 1·7-8·0]; posterior probability of superiority >99·5%). The trial steering committee and independent data monitoring committee therefore recommended expanded analysis of 426 participants recruited before Aug 8, 2023: 120 from phase 2 and 306 from phase 3. 17 participants withdrew before treatment, leaving 409 in the modified intention-to-treat population: 163 allocated to LCCRT, 168 to SCRT, and 78 to primary TME. 116 (28%) participants were female and 293 (72%) were male. Among participants who opted for organ preservation, 12-month TME-free survival was 78·5% (95% CI 72·4-85·1) with LCCRT and 60·6% (53·6-68·4) with SCRT (HR 1·90 [95% CI 1·29-2·81]). The most common grade 3-4 serious adverse events were gastrointestinal disorders (four [2%] with LCCRT vs six [4%] with SCRT vs six [8%] with TME) and procedural complications (three [2%] with LCCRT vs five [3%] with SCRT vs five [6%] with TME). One participant allocated to primary TME died after an anastomotic leak. INTERPRETATION:These early results support a response-adapted organ-preservation approach, with LCCRT appearing more effective than SCRT at 12 months. Organ-preservation might also reduce treatment-related toxicity compared with primary TME. Longer follow-up is needed for the prespecified 30-month endpoint and definitive functional and oncological outcomes. FUNDING:Cancer Research UK, Stand Up to Cancer, Dutch Cancer Society, Danish Cancer Society, Kom Op Tegen Kanker, Cancerfonden, ALF Region Stockholm, RCC Region Stockholm.

Cancer and cancer treatment have a major impact on health related quality of life (HRQoL). To improve the assessment of HRQoL in patients with cancer and evaluate the impact of policy interventions, the European Oncology Quality of Life (EUonQoL) project aims at developing a digital, patient centred system to assess HRQoL based on evaluations and preferences of cancer patients and survivors: the EUonQoL-kit. Patients across the cancer care continuum, healthcare professionals and researchers from six European countries (Denmark, France, Germany, Italy, The Netherlands and United Kingdom) were asked to rate the importance of 44 pre-selected HRQoL subdomains over a maximum of three Delphi survey rounds. We evaluated the importance of HRQoL subdomains for three target populations: patients undergoing active treatment, cancer survivors and patients receiving palliative care. The results were discussed during a consensus meeting. 96 patients and 59 healthcare professionals participated in the Delphi study. After three rounds, consensus was reached for 20 subdomains: ability to work, communication with healthcare professionals, diarrhoea, fatigue, fear of recurrence, global health status, impact of treatment side effects, impact on children/family, insomnia, instrumental activities of daily living, maintaining independence, mobility, nausea, overall quality of life, pain, partner relationship, social activity limitations, social isolation, symptom awareness and uncertain prognosis. The subdomains pain and fear of recurrence were rated as important for all three target populations. Subdomains that were considered important for the assessment of HRQoL in patients with cancer can be summarised into: physical symptoms, mobility activity, future outlook, social roles activities, family relationships, social isolation, self-efficacy, overall HRQoL, and healthcare experience. The importance of the subdomains differed for patients in different phases of the cancer care continuum. These findings were used for the creation of the first version of the EUonQoL-Kit, as a base for its further development.

Cancer treatment greatly impacts physical and psychological functioning of cancer patients, negatively affecting their quality of life (QoL). This Umbrella Review (UR) aims to systematically summarize psychological and social factors positively or negatively associated with QoL in cancer patients undergoing treatment. Four scientific databases (PubMed, Embase, Scopus, and PsycInfo) were searched to identify systematic reviews between 2012 and 2023 analyzing the relationship between QoL and psychosocial factors in cancer patients in treatment. The UR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Joanna Briggs Institute (JBI) review guidelines. The methodological quality of the included studies was evaluated using Assessment of Multiple Systematic Reviews 2 (AMSTAR2). Eighteen systematic reviews were included. The major psychological factors influencing QoL are depression, coping strategies, anxiety, and distress. Results also demonstrate the significant impact of social factors on QoL: perceived social support has a positive influence on QoL of cancer patients, while lowered social support, impaired social functioning, interactions, and role limitations worsen their QoL and overall well-being. This UR provides a comprehensive overview of the psychosocial factors impacting QoL of cancer patients and serves as a prominent base for developing questionnaires and policies aimed at measuring QoL in cancer patients undergoing treatment. Moreover, the findings of the study can guide future research or the development of personalized clinical interventions aimed at improving QoL for this cancer population group.

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.