NCT06528990 Telehealth Intervention for Ostomy Self-Management
| NCT ID | NCT06528990 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | City of Hope Medical Center |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2028-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-01-02 with a primary completion date of 2028-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Virginia Sun, PhD, RN
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT06528990 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06528990 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06528990 currently recruiting?
Yes, NCT06528990 is actively recruiting participants. Contact the research team at vsun@coh.org for enrollment information.
Where is the NCT06528990 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT06528990 clinical trial?
NCT06528990 is sponsored by City of Hope Medical Center. The principal investigator is Virginia Sun, PhD, RN at City of Hope Medical Center. The trial plans to enroll 150 participants.
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