Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Geriatric assessment and management

• Registration Number: NCT03154671
• Lead Sponsor: University of Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2018-04-10
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Geriatric assessment and management	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale	12 months	Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

Secondary Outcome Measures

Name	Time	Method
Functional status	12 months	Instrumental Activities of Daily Living (OARS IADL questionnaire)
Satisfaction with care provided	6 months	Older adult and medical oncologists will be asked to rate their satisfaction with the intervention
Overall survival	12 months	Overall survival will be abstracted from the medical chart
Cost-effectiveness	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
Unplanned health care use	6 months	Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart
Satisfaction with intervention	12 months	Older adult and medical oncologists will be asked to rate their satisfaction with the intervention
Cancer treatment plan modification	3 months	Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results
The number of geriatric issues successfully addressed for participants in intervention group	6 months	The number of referrals/recommendations made to the participant and the number implemented by the participant
Treatment toxicity	6 months	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
Intervention fidelity by treatment centre	12 months	A detailed process evaluation looking at the implementation of the intervention by centre will be conducted

Trial Locations

Locations (2)

Lakeridge Health; 🇨🇦 Oshawa, Ontario, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada