Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06528990

Telehealth Intervention for Ostomy Self-Management

Led by City of Hope Medical Center · Updated on 2026-03-05

150

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Telehealth Intervention for Ostomy Self-Management

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with bladder or colorectal cancer
  • Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary, permanent or temporary)
  • For bladder cancer, only patients with incontinent urostomies (ileal conduit) are eligible
  • Age 18 years or older
  • Ability to read and understand English for questionnaires
  • Family caregiver identified by the patient who knows the patient well and is involved in care before and after surgery
  • Family caregiver aged 18 years or older
  • Family caregiver able to read and understand English for questionnaires
  • Pregnant family caregivers are eligible
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

City of hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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Research Team

V

Virginia Sun, PhD, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Telehealth Intervention for Ostomy Self-Management | DecenTrialz