Clinical Trial

Telehealth Intervention for Ostomy Self-Management

Recruiting Phase 2
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Summary
Over one million individuals in the U.S. have ostomies. An ostomy is a surgical procedure that creates an opening in the abdominal wall that allows bodily waste (urinary or fecal) to pass through into an external pouch; in essence, it is the externalization of the gastrointestinal or urinary structures to the abdominal wall. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. The health-related quality of life impact of an ostomy is tremendous and greater than many other cancer treatments. The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention (Periop-OSMT) in patients with colorectal and bladder cancer and their family caregivers. Participants will receive seven group telehealth sessions before and after ostomy surgery. This pilot clinical trial will study the feasibility of the methods/interventions and determine the preliminary efficacy to support a larger confirmatory trial.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-26; most recent amendment 2026-03-03.
Status change: Not Yet Recruiting → Recruiting 2024-12-29
Trial Details
NCT Number NCT06528990
Lead Sponsor City of Hope Medical Center
Collaborators: United States Department of Defense
Conditions Colorectal Cancer, Bladder Cancer
Enrollment 150 participants
Start Date 2025-01-02
Primary Completion 2028-06-04 (estimated)
Study Completion 2028-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-05