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NCT Number: NCT03154671

Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeridge Health, Oshawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Geriatric assessment and management

Other

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.

Primary outcomes

  1. 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

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

    Time frame: 12 months

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

Secondary outcomes

  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 with care provided

    Time frame: 6 months

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

  8. Satisfaction with intervention

    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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Fraser Health
  • Mount Sinai Hospital, Canada
  • R.S. McLaughlin Durham Cancer Centre, Lakeridge Health
  • Sir Mortimer B. Davis - Jewish General Hospital
  • Sunnybrook Health Sciences Centre
  • The Ottawa Hospital
  • University Health Network, Toronto

Registry information

Official study title

Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 16, 2017
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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