Assessing Patient-reported & Patient-related Outcomes in Randomized Cancer Trials for Older Adults

NCT03676218 | Completed Results

• 1 other identifier: IB2016-DATECAN-elderly
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

Cancer; Elderly; Randomized controlled trial; Endpoint; Consensus

Outcome Measures

Primary Outcomes (1)

• Number of Domains Considered Relevant by the Panel of Experts When Assessing Treatment Efficacy in Randomized Cancer Trials for Older Patients With Cancer

  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.

  1 year after the consitution of the panel of experts

Study Arms (1)

Elderly cancer patients

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

Other: Elderly cancer patients

Interventions

Elderly cancer patients OTHER

No intervention: Panel of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.

Elderly cancer patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No patient will be included.

You may qualify if:

• Elderly patients with cancer

You may not qualify if:

• Individual patient data unavailable

Sponsors & Collaborators

• Institut Bergonié: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• International Society of Geriatric Oncology: collaborator

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

Related Publications (1)

• Galvin 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 RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Carine Bellera, PhD
• Organization: Institut Bergonié, Bordeaux Comprehensive Cancer Center

c.bellera@bordeaux.unicancer.fr

+33 5 56 33 04 95

Study Officials

• Carine Bellera, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: September 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 3, 2025
• Results First Posted: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)