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TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
Sponsor: University Health Network, Toronto
Summary
TOPCOP3 is a pilot factorial RCT of geriatric assessment and management, remote symptom monitoring, both interventions or neither, accompanied by an embedded process evaluation. This design is widely used to guide the evaluation of complex interventions and provides important data to aid design of larger RCTs. The trial itself falls within pilot trial goals including obtaining variance estimates for outcomes, assessment of recruitment potential, and understanding implementation issues vital to designing a larger trial. The investigators have clear feasibility objectives and an analytic plan as well as criteria to determine success and strong support from cancer advocacy and policy groups.
Official title: TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
Key Details
Gender
MALE
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2023-05-23
Completion Date
2027-02-28
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
GA+M Intervention
Typically 8 domains (cognition, comorbidities, falls risk, functional status, medication use, mood - depression, nutritional status, social support) are examined by a team consisting of a nurse and geriatrician. A GA has multiple benefits and has been recommended for all older adults considering chemotherapy by the American Society of Clinical Oncology (ASCO). For a GA to be most useful it needs to be followed by co-management of identified issues.
RSM intervention
Telephone-based, symptom management of patients with cancer
GA+RSM intervention
Combining a geriatric assessment and remote symptom control
Locations (3)
St. Michael's hospital
Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada