Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer
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|ClinicalTrials.gov Identifier: NCT03154671|
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : June 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Geriatric assessment and management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor and statistician will be blinded to group allocation|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Intervention group
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.
Other: Geriatric assessment and management
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.
No Intervention: Control group
The participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter.
- Quality of life [ Time Frame: 6 months ]Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
- Quality of Life [ Time Frame: 12 months ]Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
- Cost-effectiveness [ Time Frame: 12 months ]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
- Functional status [ Time Frame: 6 months ]Instrumental Activities of Daily Living (OARS IADL questionnaire)
- Functional status [ Time Frame: 12 months ]Instrumental Activities of Daily Living (OARS IADL questionnaire)
- The number of geriatric issues successfully addressed for participants in intervention group [ Time Frame: 6 months ]The number of referrals/recommendations made to the participant and the number implemented by the participant
- Treatment toxicity [ Time Frame: 6 months ]Grade 3-5 chemotherapy treatment toxicity using the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) and treatment completion rate (number of cycles received) will be abstracted from the medical chart
- Unplanned health care use [ Time Frame: 6 months ]Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart
- Satisfaction [ Time Frame: 6 months ]Older adult and medical oncologists will be asked to rate their satisfaction with the intervention
- Satisfaction [ Time Frame: 12 months ]Older adult and medical oncologists will be asked to rate their satisfaction with the intervention
- Cancer treatment plan modification [ Time Frame: 3 months ]Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results
- Overall survival [ Time Frame: 12 months ]Overall survival will be abstracted from the medical chart
- Intervention fidelity by treatment centre [ Time Frame: 12 months ]A detailed process evaluation looking at the implementation of the intervention by centre will be conducted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154671
|Contact: Martine Puts, RN PhD||+ 1 416-9786059||Martine.firstname.lastname@example.org|
|Contact: Shabbir Alibhai, MD MSc||+1 email@example.com|
|Oshawa, Ontario, Canada, L1G 2B9|
|Contact: Natascha Kozlowski, MSc 9055768711 firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5T 2M9|
|Principal Investigator: Shabbir M Alibhai, MD MSc|
|Principal Investigator:||Martine Puts, RN PhD||University of Toronto|