Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study

Conditions
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Cancer

Intervention / Treatment
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* Other: Geriatric assessment and management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>The participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older adult;, comprehensive geriatric assessment, chemotherapy, integrated care, randomized controlled trial