Clinical trial · Observational
Assessing Patient-reported & Patient-related Outcomes in Randomized Cancer Trials for Older Adults
Assessing Patient-reported Outcomes (PROs) and Patient-related Outcomes in Randomized Cancer Clinical Trials for Older Adults: the DATECAN-ELDERLY Initiative
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
As older adults with cancer are underrepresented in randomized clinical trials (RCT), there is limited evidence on which to rely for treatment decisions for this population. Commonly used RCT endpoints for the assessment of treatment efficacy are more often tumor-centered (e.g., progression-free survival). These endpoints may not be as relevant for the older patients who present more often with comorbidities, non-cancer-related deaths, and treatment toxicity. Moreover, their expectation and preferences are likely to differ from younger adults. The DATECAN-ELDERLY initiative combines a broad expertise, in geriatric oncology and clinical research, with interest in cancer RCT that include older patients with cancer. In order to guide researchers and clinicians coordinating cancer RCT involving older patients with cancer, the experts reviewed the literature on relevant domains to assess using patient-reported outcomes (PRO) and patient-related outcomes, as well as available tools related to these domains. Domains considered relevant by the panel of experts when assessing treatment efficacy in RCT for older patients with cancer included functional autonomy, cognition, depression and nutrition. These were based on published guidelines from international societies and from regulatory authorities as well as minimum datasets recommended to collect in RCT including older adults with cancer. In addition, health-related quality of life, patients' symptoms, and satisfaction were also considered by the panel. With regards to tools for the assessment of these domains, we highlighted that each tool has its own strengths and limitations, and very few had been validated in older adults with cancer. Further studies are thus needed to validate these tools in this specific population and define the minimum clinically important difference to use when developing RCTs in this
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elderly cancer patients | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Elderly cancer patients
- description
- Experts involved in the experts' panel for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for older patients with cancer
- interventionNames
- Other: Elderly cancer patients
Primary outcomes (1)
- measure
- Number of Domains Considered Relevant by the Panel of Experts When Assessing Treatment Efficacy in Randomized Cancer Trials for Older Patients With Cancer
- timeFrame
- 1 year after the consitution of the panel of experts
- description
- The domains were selected by the panel of experts based on the published guidelines (scientific societies, regulatory authorities, minimum datasets). Domains included functional autonomy, cognition, depression and nutrition. In addition, health-related quality of life, patients' symptoms, and satisfaction were also considered by the panel.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Elderly patients with cancer Exclusion Criteria: * Individual patient data unavailable
References
Publications (1)
- RESULTGalvin A, Soubeyran P, Brain E, Cheung KL, Hamaker ME, Kanesvaran R, Mauer M, Mohile S, Montroni I, Puts M, Rostoft S, Wildiers H, Mathoulin-Pelissier S, Bellera C. Assessing patient-reported outcomes (PROs) and patient-related outcomes in randomized cancer clinical trials for older adults: Results of DATECAN-ELDERLY initiative. J Geriatr Oncol. 2024 Jan;15(1):101611. doi: 10.1016/j.jgo.2023.101611. Epub 2023 Sep 9. PMID 37679204