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

NCT05582772 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

RSM intervention

Telephone-based, symptom management of patients with cancer

OTHER

GA+RSM intervention

Combining a geriatric assessment and remote symptom control

Sponsors & Collaborators

  • Rising Tide Foundation

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Shabbir Alibhai, MD · UHN - Princess Margaret Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582772 on ClinicalTrials.gov