Clinical trial · Interventional
Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer
Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study
- 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)
A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal perspective to study the cost-effectiveness of geriatric assessment and management compared to usual care will be conducted. Participants allocated to the control group will receive usual oncology care. Participants allocated to the intervention group will receive a comprehensive geriatric assessment and management in addition to their usual oncology care. The intervention will take 6 months to be completed. Total study follow-up will be 12 months for each participant.
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 |
|---|---|---|---|
| Geriatric assessment and management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- At study enrollment participants allocated to the intervention arm will complete a comprehensive geriatric assessment with the study intervention team (nurse and physician). Based on these findings a care plan tailored to the needs of the older adult with cancer will be developed and implemented. The study intervention nurse will call the participant at least monthly to follow up and evaluate the care (e.g. whether adjustments are required) and more if needed. All participants will receive a monthly healthy aging newsletter.
- interventionNames
- Other: Geriatric assessment and management
- type
- NO_INTERVENTION
- label
- Control group
- description
- The participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter.
Primary outcomes (2)
- measure
- Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 70+ with any solid tumor (excluding pancreatic) or lymphoma/myeloma referred for first/second line adjuvant/curative or palliative chemotherapy (cannot have received more than 1 cycle), * Able to speak English/French, * Have a physician-estimated life expectancy \>6 months, * Have an ECOG Performance Score 0-2 (indicating participants are ambulatory and able to complete all self-care activities), * Able to give informed consent. Exclusion Criteria: * Receiving palliative care services upon recruitment * Already participating in another psychosocial/educational intervention study (new treatment study is allowed if the participants would like to participate in 2 studies)
References
Publications (3)
- DERIVEDHabib MH, Alibhai SMH, Puts M. How representative are participants in geriatric oncology clinical trials? The case of the 5C RCT in geriatric oncology: A cross-sectional comparison to a geriatric oncology clinic. J Geriatr Oncol. 2024 Mar;15(2):101703. doi: 10.1016/j.jgo.2024.101703. Epub 2024 Jan 15. PMID 38228054
- DERIVEDPuts M, Alqurini N, Strohschein F, Koneru R, Szumacher E, Mariano C, Monette J, Hsu T, Brennenstuhl S, McLean B, Wills A, Berger A, Amir E, Romanovsky L, Li A, Mehta R, Krzyzanowska M, Elser C, Jang R, Prica A, Wan-Chow-Wah D, Pitters E, Emmenegger U, Menjak IB, Bergman S, Lemonde M, Breunis H, Beland F, Alibhai SMH. Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial. J Clin Oncol. 2023 Feb 1;41(4):847-858. doi: 10.1200/JCO.22.01007. Epub 2022 Dec 6. PMID 36473126
- DERIVEDPuts MTE, Hsu T, Mariano C, Monette J, Brennenstuhl S, Pitters E, Ray J, Wan-Chow-Wah D, Kozlowski N, Krzyzanowska M, Amir E, Elser C, Jang R, Prica A, Krahn M, Beland F, Bergman S, Koneru R, Lemonde M, Szumacher E, Zidulka J, Fung S, Li A, Emmenegger U, Mehta R, Flemming K, Breunis H, Alibhai SMH. Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial. BMJ Open. 2019 May 10;9(5):e024485. doi: 10.1136/bmjopen-2018-024485. PMID 31079079