Cancer
Conditions
Keywords
older adult;, comprehensive geriatric assessment, chemotherapy, integrated care, randomized controlled trial
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.
Interventions
OTHERGeriatric 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.
Sponsors
University Health Network, Toronto
The Ottawa Hospital
Sir Mortimer B. Davis - Jewish General Hospital
R.S. McLaughlin Durham Cancer Centre, Lakeridge Health
Sunnybrook Health Sciences Centre
Fraser Health
Mount Sinai Hospital, Canada
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor and statistician will be blinded to group allocation
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | 6 months | Instrumental Activities of Daily Living (OARS IADL questionnaire) |
| 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 |
| Unplanned health care use | 6 months | Unplanned hospitalization and emergency department visits abstracted from patient diary and 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 |
| 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 |
| Overall survival | 12 months | Overall survival 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 |
| Satisfaction with care provided | 6 months | Older adult and medical oncologists will be asked to rate their satisfaction with the intervention |
Countries
Canada
Outcome results
None listed