Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Geriatric assessment and management

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health
    • Toronto, Ontario, Canada, M5T 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: University Health Network, Toronto; Sunnybrook Health Sciences Centre; The Ottawa Hospital; Fraser Health; Mount Sinai Hospital, Canada; Sir Mortimer B. Davis - Jewish General Hospital; R.S. McLaughlin Durham Cancer Centre, Lakeridge Health
• Investigators: Principal Investigator: Martine Puts, RN PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; chemotherapy; comprehensive geriatric assessment; older adult;; integrated care
• Other Study ID Numbers: 705046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No