RecruitingNot ApplicableNCT05582772

TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer

TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation

Sponsor

University Health Network, Toronto

Enrollment

168 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a supportive care program for older men with metastatic prostate cancer who are starting or switching to a type of hormone therapy called an androgen receptor axis-targeted therapy (ARAT). The program focuses on helping patients manage side effects, maintain function, and improve quality of life through nurse-led telephone support. **You may be eligible if...** - You are 65 or older - You have metastatic prostate cancer (cancer spread beyond the prostate) - You are starting or recently switched to an ARAT hormone therapy - You have a working telephone **You may NOT be eligible if...** - You cannot communicate in English - You have severe depression or moderate to severe dementia - Your doctor estimates you have less than 3 months to live Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGA+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.

OTHERRSM intervention

Telephone-based, symptom management of patients with cancer

OTHERGA+RSM intervention

Combining a geriatric assessment and remote symptom control