Brief Title: Telehealth Intervention for Ostomy Self-Management

INTRODUCTION

• Org Study ID: 24275
• Secondary ID: N/A
• NCT ID: NCT06528990
• Sponsor: City of Hope Medical Center

BRIEF 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.

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DETAILED DESCRIPTION

An ostomy is a disability that adversely affects the HRQOL of cancer survivors and their support persons/family caregivers (FCGs) at all phases of cancer survivorship. More than half of survivors experience stoma-related challenges such as pain, troublesome odor, skin problems around the stoma, and leakage. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality, psychological problems, and interference with work, and recreation and sporting activities. The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention (Periop-OSMT) and to determine the preliminary efficacy of the intervention on participant-reported outcomes, compared to the usual care arm. We hypothesize that the intervention will be feasible, acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm.

• Overall Status
  Recruiting
• Start Date
  January 30, 2025
• Phase
  Phase 2
• Study Type
  Interventional