TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer
Recruiting now · Not applicable
Conditions studied: Metastatic Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05582772
- Run by
- University Health Network, Toronto
- People needed
- 168
- Starts
- 2023-05-23
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2025-07-03
Who can join
Age: 65 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Starting an ARAT or started an ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
- Diagnosed with mPC (castration-sensitive or resistant) or nmCRPC (non-metastatic castration-resistant prostate cancer)
- At least 65 years old
- Able to provide written informed consent
- Has a working telephone
You may not qualify if…
- Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
- Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia)
- Life expectancy <3 months as estimated by the oncologist
Where it is running
- St. Michael's hospital — Toronto, Ontario, Canada (enrolling)
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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