Status:
RECRUITING
Telehealth Intervention for Ostomy Self-Management
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Colorectal Cancer
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 expe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 4 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06528990
Start Date
January 2 2025
End Date
June 4 2028
Last Update
February 25 2025
Active Locations (1)
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1
City of hope Medical Center
Duarte, California, United States, 91010