Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

University of Toronto351 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

351

Conditions

Cancer

Interventions

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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)

Locations (2)

Lakeridge Health

Oshawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

Time frame: 6 months

Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Functional status

Instrumental Activities of Daily Living (OARS IADL questionnaire)

Time frame: 6 months

Functional status

Instrumental Activities of Daily Living (OARS IADL questionnaire)

Time frame: 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

Time frame: 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

Time frame: 6 months

Unplanned health care use

Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart

Time frame: 6 months

Satisfaction with care provided

Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

Time frame: 6 months

Satisfaction with intervention

Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

Time frame: 12 months

Cancer treatment plan modification

Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results

Time frame: 3 months

Overall survival

Overall survival will be abstracted from the medical chart

Time frame: 12 months

Intervention fidelity by treatment centre

A detailed process evaluation looking at the implementation of the intervention by centre will be conducted

Time frame: 12 months