Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer.

BACKGROUND: Adolescents and young adults (AYAs) with cancer, defined as individuals aged 15-39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer. METHODS: The methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine "what to measure" (i.e., outcomes); (6) determine "how to measure" (i.e., measures); and (7) determine "case-mix" variables. CONCLUSIONS: The development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.

A patient's perspective on the side effects of tyrosine kinase inhibitors in the treatment of advanced and metastatic gastrointestinal stromal tumors.

Aim: To provide the gastrointestinal stromal tumor patient's perspective on side effects of tyrosine kinase inhibitors and compare this with that of healthcare professionals. Materials & methods: Semi-structured interviews were conducted with 19 patients with an advanced or metastatic gastrointestinal stromal tumor, as well as six healthcare professionals, and five patients participated in a focus group. Thematic analysis was used to interpret the data. Results: Most participants (n = 29) reported gastrointestinal symptoms followed by tiredness (n = 25), edema (n = 22), muscle cramps (n = 21), skin problems (n = 21), eye problems (n = 11) and trouble sleeping (n = 10). Patients, but not healthcare professionals, reported cognitive problems or symptoms of depression. Conclusion: These results underline the importance of including the patient's perspective, as there is a gap in symptom reporting between patients and healthcare professionals.

In this study, the authors report on the side effects of targeted therapies used in the treatment of gastrointestinal stromal tumors from the patient's perspective and draw comparisons with reports from healthcare professionals. The authors conducted interviews with both patients and healthcare professionals. Most participants reported gastrointestinal symptoms followed by tiredness, fluid retention, muscle cramps, skin problems, eye problems and trouble sleeping. Gastrointestinal stromal tumor patients reported cognitive problems and symptoms of depression, which were not reported by healthcare professionals. In conclusion, the authors' results highlight the importance of including the patient's perspective, as there is a gap in symptom reporting between patients and healthcare professionals.

Updating our understanding of health-related quality of life issues in children with cancer: a systematic review of patient-reported outcome measures and qualitative studies.

BACKGROUND: Health-related quality of life (HRQOL) is a key concept in pediatric oncology. This systematic review aims to update the conceptual HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), covering physical, emotional, social and general HRQOL aspects, and to present a comprehensive overview of age- and disease-specific HRQOL issues in children with cancer. METHODS: Medline, PsychINFO, the Cochrane Database for Systematic Reviews (CDSR), and the COSMIN database were searched (up to 31.12.2020) for publications using patient-reported outcome measures (PROMs) and qualitative studies in children with cancer (8-14-year) or their parents. Items and quotations were extracted and mapped onto the conceptual model for HRQOL in children with cancer mentioned above. RESULTS: Of 2038 identified studies, 221 were included for data extraction. We identified 96 PROMS with 2641 items and extracted 798 quotations from 45 qualitative studies. Most items and quotations (94.8%) could be mapped onto the conceptual model. However, some adaptations were made and the model was complemented by (sub)domains for 'treatment burden', 'treatment involvement', and 'financial issues'. Physical and psychological aspects were more frequently covered than social issues. DISCUSSION: This review provides a comprehensive overview of HRQOL issues for children with cancer. Our findings mostly support the HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), but some adaptations are suggested. This review may be considered a starting point for a refinement of our understanding of HRQOL in children with cancer. Further qualitative research will help to evaluate the comprehensiveness of the HRQOL model and the relevance of the issues it encompasses.

A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire.

PURPOSE: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. METHODS: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient). RESULTS: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68-0.92) and test-retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. CONCLUSION: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.

Systematic review of health-related quality of life (HRQoL) issues associated with gastric cancer: capturing cross-cultural differences.

The treatment landscape for gastric cancer (GC) is constantly evolving with therapies affecting all aspects of health-related quality of life (HRQoL) which need careful monitoring. While there are HRQoL measures designed specifically to capture issues relevant to patients with GC, these might be outdated and only relevant to patients in westernised cultures. This review identifies the patient-reported measures used to assess HRQoL of patients with GC and compares the HRQoL measures used across cultures including East Asia, where GC is more prevalent. We conducted a systematic review of publications between January 2001 and January 2021. A total of 267 papers were identified; the majority (66%) of studies involved patients from East Asian countries. Out of the 24 HRQoL questionnaires captured, the European Organisation for Research and Treatment of Cancer Core Cancer measure (QLQ-C30) was the most widely used (60% of all studies and 62% of those involving patients from East Asian countries), followed by its gastric cancer-specific module (QLQ-STO22, 34% of all studies and 41% from East Asia). Eight questionnaires were developed within East Asian countries and, of the 20 studies including bespoke questions, 16 were from East Asia. There were six qualitative studies. HRQoL issues captured include diarrhoea, constipation, reflux, abdominal pain and abdominal fulness or bloating, difficulty swallowing, restricted eating, and weight loss. Psychosocial issues related to these problems were also assessed. Issues relating to the compatibility of some of the westernised measures within East Asian cultures were highlighted.

'I thought I had fibroids, and now I don't': a mixed method study on health-related quality of life in uterine sarcoma patients.

BACKGROUND: Uterine sarcomas are rare subtypes of primary urogenital tumours and need tailored treatment. This study aimed to examine the impact of diagnosis and treatment on health-related quality of life (HRQoL) in patients with uterine sarcoma and measures available to assess HRQoL in this group. METHODS: Thirteen patients with uterine sarcoma and 23 health care professionals were purposively sampled from sarcoma reference centers and participated in a semi-structured interview exploring HRQoL. Patients were also asked to review the EORTC QLQ-C30 and EORTC QLQ-EN24 for relevance. Data were analysed using thematic analysis and descriptive statistics. RESULTS: The most commonly reported physical health issues were related to sexual dysfunction and urological symptoms. Hormone-related issues and gastrointestinal symptoms were also identified. Cancer-generic issues such as functional problems, fatigue, pain, and treatment-related adverse effects were also reported. Regarding mental health, fears (about having sex, of recurrence, or of death), altered body-image, and dealing with lacking knowledge regarding sarcoma had an impact on HRQoL. Social health issues were related to the impact on relationships with others, limitations in undertaking activities, loss of independence, changes in work or study capacity, and financial difficulties. Most of the items of the EORTC QLQ-C30 and EORTC QLQ-EN24 questionnaires were rated as relevant. Questions about lack of knowledge about sarcoma, shock of diagnosis, and menopausal symptoms were lacking from existing measures. CONCLUSIONS: Uterine sarcoma patients experience a variety of concerns covering the physical, mental, and social domains of HRQoL that are in the main EORTC instruments, but not all of them. Combining cancer-generic, location- and sarcoma-specific items is recommended to assess HRQoL in this patient group. Trial registration NCT04071704.

Clinical research tools in pediatric oncology: challenges and opportunities.

Survival for childhood cancers has improved significantly over the last decades. However, patient outcomes have plateaued over the last decade for difficult-to-treat diseases. With high cure rates, decreasing long-term toxicities and sequelae remains crucial. Since many advances in childhood cancer research come from the adult oncology world, one of the key areas is improving the adaptation of tools that are essential for clinical trial conduct that were developed for adults into pediatrics. These include tools to evaluate toxicity, quality of life, radiological response, statistical methodology, or indicators of cancer care quality. In this review, we present ongoing international efforts to validate and adapt these tools for children and adolescents and discuss remaining challenges. These efforts will hopefully accelerate and improve the quality of pediatric oncology research in the upcoming years.

COVID-19 and children with cancer: Parents' experiences, anxieties and support needs.

BACKGROUND: Children with cancer were designated as clinically extremely vulnerable if they were to contract SARS-CoV-2 due to immune suppression in the early phase of the COVID-19 pandemic. Our aim was to explore experiences, information and support needs, and decision making of parents with a child with cancer in response to this phase in the United Kingdom. METHODS: Parents of a child with cancer completed a survey at a time when the UK moved into a period of 'lockdown'. An online survey was developed by the research team to capture parents' experiences, information and support needs, and decision making, using closed statements and open text boxes. Descriptive quantitative analyses and qualitative thematic content analysis were undertaken. FINDINGS: One hundred seventy-one parents/caregivers completed the survey. Eighty-five percent were worried about the virus and they were vigilant about the virus (92%) or cancer symptoms (93.4%). For two-thirds (69.6%), hospital was no longer considered a safe place. Eight overarching themes were identified related to the virus: (a) risk of infection; (b) information, guidance and advice; (c) health care provision; (d) fears and anxieties; or related to lockdown/isolation: (e) psychological and social impact; (f) keeping safe under lockdown; (g) provisions and dependence; and (h) employment and income. CONCLUSIONS: This is the first study, to the best of our knowledge, to report experiences of parents of a child with cancer during the SARS-CoV-2/COVID-19 pandemic. The majority of parents were worried about SARS-CoV-2 and transmitting the virus to their child. Hospital was no longer perceived to be a safe place, and parents were worried about suboptimal cancer care. Parents described fear and anxiety and the psychological, social and economic impact of isolation.

Nutritional care in colorectal cancer-what is the state of play?

AIM: Nutrition is associated with aetiology and impacts outcomes in colorectal cancer (CRC). This study aimed to explore nutritional symptoms and concerns of patients with CRC and CRC dietetic resource across the UK. METHODS: Study 1 is a descriptive analysis of nutrition-related measures in the ColoRectal Wellbeing (CREW) study, a prospective 5-year longitudinal cohort study of a representative sample of 872 adults with non-metastatic CRC. Study 2 is a descriptive analysis of data collected using a freedom of information request to all UK trusts/boards on dietetic resources for CRC. RESULTS: Study 1 found that 31% of CREW participants wanted more diet and lifestyle advice. At 3 months post-surgery, 10% reported poor appetite. A fifth experienced weight loss and 16% had concerns regarding weight loss 9 months post-surgery. In study 2 just 3% of hospitals providing CRC services had a dedicated CRC dietitian (hepato-pancreato-biliary, 11.1%; head and neck cancer, 14.3%). There was no dietetic outpatient follow-up of CRC patients in 72% of hospitals. CONCLUSIONS: Dietetic resource for patients with CRC is scarce even though weight loss, poor appetite and unmet needs are common and persist over time. Work is needed to embed nutritional care into the management of patients with CRC.

Does age matter? A comparison of health-related quality of life issues of adolescents and young adults with cancer.

OBJECTIVE: Health-related quality of life (HRQoL) concerns of adolescents and young adults (AYAs) aged 14-25 years were compared with those of older adults (26-60 years) with cancer. METHODS: AYAs and older adults receiving curative intent treatment or supportive palliative care for cancer were recruited from eight research centres across Europe. Participants used a rating scale to score the relevance and importance of a list of 77 issues covering 10 areas of HRQoL concern: symptoms; activity restrictions; social; emotional; body image; self-appraisals; outlook on life; lifestyle; treatment-related and life beyond treatment. RESULTS: HRQoL issues were reviewed by 33 AYAs and 25 older adults. Several issues were recognised as relevant and important across all age groups: symptoms, emotional impact, outlook on life, lifestyle and treatment-related. A number of issues were more relevant or important to AYAs including interrupted education, greater motivation to achieve academic goals, increased maturity, boredom, fertility and change in living situation. CONCLUSION: While there is overlap in several of the HRQoL concerns across the age span, it is important that HRQoL measures used with AYAs capture the diverse and unique psychosocial aspects of this developmental stage.

Social support following diagnosis and treatment for colorectal cancer and associations with health-related quality of life: Results from the UK ColoREctal Wellbeing (CREW) cohort study.

OBJECTIVE: Social support is acknowledged as important in cancer survivorship, but little is known about change in support after cancer diagnosis and factors associated with this, particularly in colorectal cancer. The CREW cohort study investigated social support up to 2 years following curative intent surgery for colorectal cancer. METHODS: A total of 871 adults recruited pre-treatment from 29 UK centres 2010 to 2012 consented to follow-up. Questionnaires at baseline, 3, 9, 15, and 24 months post-surgery included assessments of social support (Medical Outcomes Study-Social Support Survey, MOS-SSS) and health-related quality of life (HRQoL). Socio-demographic, clinical and treatment details were collected. Longitudinal analyses assessed social support over follow-up, associations with participant characteristics, and HRQoL. RESULTS: Around 20% were living alone and 30% without a partner. Perceived social support declined in around 29% of participants, with 8% of these reporting very low levels overall from baseline to 2 years (mean MOS-SSS overall score < 40 on a scale from 0 to 100). Older age, female gender, greater neighbourhood deprivation, presence of co-morbidities, and rectal cancer site were significantly associated with reductions in perceived support. Poorer HRQoL outcomes (generic health/QoL, reduced wellbeing, anxiety, and depression) were significantly associated with lower levels of social support. CONCLUSIONS: Levels of social support decline following colorectal cancer diagnosis and treatment in nearly a third of patients and are an important risk factor for recovery of HRQoL. Assessment of support early on and throughout follow-up would enable targeted interventions to improve recovery, particularly in the more vulnerable patient groups at risk of poorer social support.

Systematic review of the health-related quality of life issues facing adolescents and young adults with cancer.

PURPOSE: For adolescents and young adults (AYAs), the impact of a cancer diagnosis and subsequent treatment is likely to be distinct from other age groups given the unique and complex psychosocial challenges of this developmental phase. In this review of the literature, we report the health-related quality of life (HRQoL) issues experienced by AYAs diagnosed with cancer and undergoing treatment. METHODS: MEDLINE, EMBASE, CINAHL, PsychINFO and the Cochrane Library Databases were searched for publications reporting HRQoL of AYAs. Issues generated from interviews with AYAs or from responses to patient reported outcome measures (PROMs) were extracted. RESULTS: 166 papers were reviewed in full and comprised 72 papers covering 69 primary studies, 49 measurement development or evaluation papers and 45 reviews. Of the 69 studies reviewed, 11 (16%) used interviews to elicit AYAs' descriptions of HRQoL issues. The majority of the PROMs used in the studies represent adaptations of paediatric or adult measures. HRQoL issues were organised into the following categories: physical, cognitive, restricted activities, relationships with others, fertility, emotions, body image and spirituality/outlook on life. CONCLUSION: The HRQoL issues presented within this review are likely to be informative to health care professionals and AYAs. The extensive list of issues suggests that the impact of a cancer diagnosis and treatment during adolescence and young adulthood is widespread and reflects the complexities of this developmental phase.

Systematic review of the quality of life issues associated with anal cancer and its treatment with radiochemotherapy.

PURPOSE: Radiochemotherapy is the standard of care for the treatment of anal carcinoma achieving good loco-regional control and sphincter preservation. This approach is however associated with acute and late toxicities including haematological, skin, bowel function and genito-urinary complications. This paper systematically reviews studies addressing the quality of life (QoL) implications of anal cancer and radiochemotherapy. The paper also evaluates how QoL is assessed in anal cancer. METHODS: Medline, EMBASE, CINAHL, PsycInfo, Web of Science and the Cochrane Library were searched for publications (1996-2014) reporting the effects on patients of anal cancer and radiochemotherapy. RESULTS: Of the 152 papers reporting treatment-related effects on patients, only 11 provided a formal assessment of QoL. In the absence of an anal cancer-specific measure, QoL was assessed using generic cancer instruments such as the core EORTC quality of life questionnaire (EORTC QLQ-C30) or colorectal cancer tools such as the EORTC QLQ-CR29. Bowel function, particularly diarrhoea, and sexual problems were the most commonly reported QoL concerns. The review of QoL issues of anal cancer patients treated with radiochemotherapy is limited by the QoL assessment measures used. It is argued that certain treatment-related toxicities, for example skin-induced radiation problems, are overlooked or inadequately represented in existing measures. CONCLUSIONS: This review emphasises the need to develop an anal cancer-specific QoL measure and to incorporate QoL as an outcome of future trials in anal cancer. The results of this review are informative to clinicians and patients in terms of treatment decision-making.

A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review.

BACKGROUND: With increasing survival rates in pediatric oncology, the need to monitor health-related quality of life (HRQOL) is becoming even more important. However, available patient-reported outcome measures (PROMs) have been criticized. This review aims to systematically evaluate the content validity of PROMs for HRQOL in children with cancer. METHODS: In December 2021, a systematic literature search was conducted in PubMed. PROMs were included if they were used to assess HRQOL in children with cancer and had a lower age-limit between 8 and 12 years and an upper age-limit below 21 years. The COSMIN methodology for assessing the content validity of PROMs was applied to grade evidence for relevance, comprehensiveness, and comprehensibility based on quality ratings of development studies (i.e., studies related to concept elicitation and cognitive interviews for newly developed questionnaires) and content validity studies (i.e., qualitative studies in new samples to evaluate the content validity of existing questionnaires). RESULTS: Twelve PROMs were included. Due to insufficient patient involvement and/or poor reporting, the quality of most development studies was rated 'doubtful' or 'inadequate'. Few content validity studies were available, and these were mostly 'inadequate'. Following the COSMIN methodology, evidence for content validity was 'low' or 'very low' for almost all PROMs. Only the PROMIS Pediatric Profile had 'moderate' evidence. In general, the results indicated that the PROMs covered relevant issues, while results for comprehensiveness and comprehensibility were partly inconsistent or insufficient. DISCUSSION: Following the COSMIN methodology, there is scarce evidence for the content validity of available PROMs for HRQOL in children with cancer. Most instruments were developed before the publication of milestone guidelines and therefore were not able to fulfill all requirements. Efforts are needed to catch up with methodological progress made during the last decade. Further research should adhere to recent guidelines to develop new instruments and to strengthen the evidence for existing PROMs.

Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types.

INTRODUCTION: Early guidelines for minimally important differences (MIDs) 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 enroled 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.

International Validation of the EORTC QLQ-ANL27, a Field Study to Test the Anal Cancer-Specific Health-Related Quality-of-Life Questionnaire.

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) health-related quality of life questionnaire for anal cancer (QLQ-ANL27) supplements the EORTC cancer generic measure (QLQ-C30) to measure concerns specific to people with anal cancer treated with chemoradiotherapy. This study tested the psychometric properties and acceptability of the QLQ-ANL27. METHODS AND MATERIALS: People with anal cancer were recruited from 15 countries to complete the QLQ-C30 and QLQ-ANL27 and provide feedback on the QLQ-ANL27. Item responses, scale structure (multitrait scaling, factor analysis), reliability (internal consistency and reproducibility) and sensitivity (known group comparisons and responsiveness to change) of the QLQ-ANL27 were evaluated. RESULTS: Data from 382 people were included in the analyses. The EORTC QLQ-ANL27 was acceptable, comprehensive, and easy to complete, taking an average 8 minutes to complete. Psychometric analyses supported the EORTC QLQ-ANL27 items and reliability (Cronbach's α ranging from 0.71-0.93 and test-retest coefficients above 0.7) and validity of the scales (particularly nonstoma bowel symptoms and pain/discomfort). Most scales distinguished people according to treatment phase and performance status. Bowel (nonstoma), pain/discomfort, and vaginal symptoms were sensitive to deteriorations over time. The stoma-related scales remained untested because of low numbers of people with a stoma. Revisions to the scoring and question ordering of the sexual items were proposed. CONCLUSIONS: The QLQ-ANL27 has good psychometric properties and is available in 16 languages for people treated with chemoradiotherapy for anal cancer. It is used in clinical trials and has a potential role in clinical practice.

Radiotherapy in Metastatic Urothelial Carcinoma: Rationale and Clinical Applications.

Urothelial carcinoma is the most common type of bladder cancer including upper urinary tract urothelial cell carcinoma (renal pelvis and ureters) and urethral carcinoma. It exhibits high mortality and morbidity rates and is usually diagnosed at a late, incurable stage, carrying a poor prognosis. Local symptoms in patients with metastatic urothelial carcinoma (mUC) have an adverse impact on quality of life (QoL) and are associated with frequent hospitalizations. Herein, we review the role of palliative radiotherapy in mUC as the means to ameliorate a wide range of symptoms, seeking optimum patient stratification, even though the latter should be balanced against any acute or late toxicity that may arise. For this, links to the molecular biology of mUC are explored and QoL assessments are presented. To maximize patient benefit from radiotherapy, we conclude that multi-modal datasets need to be re-visited to better inform multi-center studies where policy makers, health professionals, researchers, and patient groups meet. Radiotherapy either as a monotherapy or alongside systemic therapy may serve as an added value.

Patient-reported outcomes are under-utilised in evaluating supportive therapies in paediatric oncology - A systematic review of clinical trial registries.

BACKGROUND: Children with cancer suffer from numerous symptoms and side-effects, making supportive interventions indispensable to improve their quality of life. The gold standard for evaluating the latter is patient-reported outcome (PRO) assessment. This systematic review investigates the current practice of clinical outcome assessment (COA) in clinical trials on supportive interventions. METHODS: ClinicalTrials.gov and EudraCT were searched for trials including children and adolescents (≤21 years) with cancer receiving supportive care registered 2007-2020. The use of different types of COAs was analysed, focusing on PRO assessment and the domains measured with PRO measures (PROMs). Associations with trial characteristics were investigated using univariate and multivariable analyses. RESULTS: Of 4789 identified trials, 229 were included. Among them, 44.1 % relied on PROMs, the most commonly used COA. The proportion of trials using PROMs did not significantly differ over time. In the multivariable analysis, intervention type (higher PROM use in behavioural vs. medical interventional trials) and cancer type (higher PROM use in mixed and solid tumour samples vs. haematological samples) were significant predictors of PROM use. The majority of trials using PROMs (59.6 %) measured more than one health domain. 'Physical health' was the most frequently assessed domain (92.6 %). CONCLUSION: Less than half of registered clinical trials investigating supportive interventions for children with cancer used PROMs. This result is striking since supportive care explicitly focuses on patients' quality of life, which is best assessed using PROMs. Our systematic review underlines the need to identify barriers for PROM implementation and to improve PRO research in paediatric oncology.