NCT06528990RecruitingPhase 2
Telehealth Intervention for Ostomy Self-Management
Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- 2 Jan 2025
- Primary completion date
- 4 Jun 2028
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Bladder cancer, Colorectal cancer
- NCT number
- NCT06528990
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 2 Jan 2025 to the primary completion date, 4 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient Eligibility Criteria:
- 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
- Ability to read and understand English for Questionnaires
- Family Caregiver Eligibility Criteria:
- A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's care before and after surgery
- Age: ≥ 18 years
- Ability to read and understand English for Questionnaires
- Pregnant FCGs are eligible for participation. Participation in this behavioral/educational intervention should not impact the pregnancy/fetus.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.