Clinical trial NCT03154671: Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer
Official title: Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: older adult;
comprehensive geriatric assessment
chemotherapy
integrated care
randomized controlled trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: The Ottawa Hospital
name: Sir Mortimer B. Davis - Jewish General Hospital
name: R.S. McLaughlin Durham Cancer Centre, Lakeridge Health
name: Sunnybrook Health Sciences Centre
name: Fraser Health
name: Mount Sinai Hospital, Canada
First posted: 2017-05-16
Enrollment: 351
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
timeFrame: 6 months
measure: Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
timeFrame: 12 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 12 months
measure: Functional status
timeFrame: 6 months
measure: Functional status
timeFrame: 12 months
measure: The number of geriatric issues successfully addressed for participants in intervention group
timeFrame: 6 months
measure: Treatment toxicity
timeFrame: 6 months
measure: Unplanned health care use
timeFrame: 6 months
measure: Satisfaction with care provided
timeFrame: 6 months
measure: Satisfaction with intervention
timeFrame: 12 months
measure: Cancer treatment plan modification
timeFrame: 3 months
measure: Overall survival
timeFrame: 12 months
measure: Intervention fidelity by treatment centre
timeFrame: 12 months
Other outcomes:
Locations:
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Martine Puts, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.