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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| The Ottawa Hospital | OTHER |
| Sir Mortimer B. Davis - Jewish General Hospital | OTHER |
| R.S. McLaughlin Durham Cancer Centre, Lakeridge Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | No Intervention | The participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric assessment and management | Other | Each participant will receive a comprehensive geriatric assessment at baseline. Based on the issues identified, a tailored care plan will be developed with the participant to address the issues identified. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale | Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale | 6 months |
| Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale | Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost-effectiveness will be determined alongside the clinical trial following standard guidelines. 2 methods to collect data needed for the cost-effectiveness analyses: 1) EQ-5D-5L and 2) patient health care use diaries | 12 months |
| Functional status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Puts, RN PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada | ||
| Princess Margaret Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38228054 | Derived | Habib 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. | |
| 36473126 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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| UNKNOWN |
| Sunnybrook Health Sciences Centre | OTHER |
| Fraser Health | OTHER |
| Mount Sinai Hospital, Canada | OTHER |
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The outcome assessor and statistician will be blinded to group allocation
Instrumental Activities of Daily Living (OARS IADL questionnaire) |
| 6 months |
| Functional status | Instrumental Activities of Daily Living (OARS IADL questionnaire) | 12 months |
| The number of geriatric issues successfully addressed for participants in intervention group | The number of referrals/recommendations made to the participant and the number implemented by the participant | 6 months |
| Treatment toxicity | Grade 3-5 chemotherapy treatment toxicity using the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)[12] and treatment completion rate (number of cycles received) will be abstracted from the medical chart | 6 months |
| Unplanned health care use | Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart | 6 months |
| Satisfaction with care provided | Older adult and medical oncologists will be asked to rate their satisfaction with the intervention | 6 months |
| Satisfaction with intervention | Older adult and medical oncologists will be asked to rate their satisfaction with the intervention | 12 months |
| Cancer treatment plan modification | Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results | 3 months |
| Overall survival | Overall survival will be abstracted from the medical chart | 12 months |
| Intervention fidelity by treatment centre | A detailed process evaluation looking at the implementation of the intervention by centre will be conducted | 12 months |
| Toronto |
| Ontario |
| M5T 2M9 |
| Canada |
| Puts 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. |
| 31079079 | Derived | Puts 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. |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |