Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154671
• Other study ID #: 705046
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2022
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Lakeridge Health	Oshawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
University of Toronto	Fraser Health, Mount Sinai Hospital, Canada, R.S. McLaughlin Durham Cancer Centre, Lakeridge Health, Sir Mortimer B. Davis - Jewish General Hospital, Sunnybrook Health Sciences Centre, The Ottawa Hospital, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Functional status	Instrumental Activities of Daily Living (OARS IADL questionnaire)	6 months
Secondary	Functional status	Instrumental Activities of Daily Living (OARS IADL questionnaire)	12 months
Secondary	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
Secondary	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
Secondary	Unplanned health care use	Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart	6 months
Secondary	Satisfaction with care provided	Older adult and medical oncologists will be asked to rate their satisfaction with the intervention	6 months
Secondary	Satisfaction with intervention	Older adult and medical oncologists will be asked to rate their satisfaction with the intervention	12 months
Secondary	Cancer treatment plan modification	Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results	3 months
Secondary	Overall survival	Overall survival will be abstracted from the medical chart	12 months
Secondary	Intervention fidelity by treatment centre	A detailed process evaluation looking at the implementation of the intervention by centre will be conducted	12 months