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Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

Sponsor
University of Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03154671
Collaborator
University Health Network, Toronto (Other), The Ottawa Hospital (Other), Sir Mortimer B. Davis - Jewish General Hospital (Other), R.S. McLaughlin Durham Cancer Centre, Lakeridge Health (Other), Sunnybrook Health Sciences Centre (Other), Fraser Health (Other), Mount Sinai Hospital, Canada (Other)
351
Enrollment
2
Locations
2
Arms
35.7
Actual Duration (Months)
175.5
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Geriatric assessment and management
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
351 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessor and statistician will be blinded to group allocation
Primary Purpose:
Supportive Care
Official Title:
Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale [12 months]

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

Secondary Outcome Measures

  1. 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

  2. Functional status [6 months]

    Instrumental Activities of Daily Living (OARS IADL questionnaire)

  3. Functional status [12 months]

    Instrumental Activities of Daily Living (OARS IADL questionnaire)

  4. 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

  5. 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

  6. Unplanned health care use [6 months]

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

  7. Satisfaction with care provided [6 months]

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

  8. Satisfaction with intervention [12 months]

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

  9. Cancer treatment plan modification [3 months]

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

  10. Overall survival [12 months]

    Overall survival will be abstracted from the medical chart

  11. Intervention fidelity by treatment centre [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lakeridge Health Oshawa Ontario Canada L1G 2B9
2 Princess Margaret Cancer Centre Toronto Ontario Canada M5T 2M9

Sponsors and Collaborators

  • University of Toronto
  • 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

Investigators

  • Principal Investigator: Martine Puts, RN PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martine Puts, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier:
NCT03154671
Other Study ID Numbers:
  • 705046
First Posted:
May 16, 2017
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Martine Puts, Assistant Professor, University of Toronto
older adult;
comprehensive geriatric assessment
chemotherapy
integrated care
randomized controlled trial

Study Results

No Results Posted as of May 20, 2022