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Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

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ClinicalTrials.gov Identifier: NCT03154671
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Martine Puts, University of Toronto

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
Cancer Other: Geriatric assessment and management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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 : April 10, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
    Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

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


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 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 [ Time Frame: 6 months ]
    Instrumental Activities of Daily Living (OARS IADL questionnaire)

  3. Functional status [ Time Frame: 12 months ]
    Instrumental Activities of Daily Living (OARS IADL questionnaire)

  4. The number of geriatric issues successfully addressed for participants in intervention group [ Time Frame: 6 months ]
    The number of referrals/recommendations made to the participant and the number implemented by the participant

  5. Treatment toxicity [ Time Frame: 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 [ Time Frame: 6 months ]
    Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart

  7. Satisfaction [ Time Frame: 6 months ]
    Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

  8. Satisfaction [ Time Frame: 12 months ]
    Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

  9. Cancer treatment plan modification [ Time Frame: 3 months ]
    Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results

  10. Overall survival [ Time Frame: 12 months ]
    Overall survival will be abstracted from the medical chart

  11. Intervention fidelity by treatment centre [ Time Frame: 12 months ]
    A detailed process evaluation looking at the implementation of the intervention by centre will be conducted



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154671


Contacts
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Contact: Martine Puts, RN PhD + 1 416-9786059 Martine.puts@utoronto.ca
Contact: Shabbir Alibhai, MD MSc +1 416-340-5125 shabbir.alibhai@uhn.ca

Locations
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Canada, Ontario
Lakeridge Health Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Natascha Kozlowski, MSc    9055768711    nakozlowski@lakeridgehealth.on.ca   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5T 2M9
Principal Investigator: Shabbir M Alibhai, MD MSc         
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
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Principal Investigator: Martine Puts, RN PhD University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martine Puts, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03154671     History of Changes
Other Study ID Numbers: 705046
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martine Puts, University of Toronto:
older adult;
comprehensive geriatric assessment
chemotherapy
integrated care
randomized controlled trial