Telehealth support for managing ostomies in cancer patients
Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors
This study is testing a telehealth program to help people with colorectal and bladder cancer manage their ostomies better before and after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06528990 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate a telehealth intervention designed to assist patients with colorectal and bladder cancer in managing their ostomies. Participants will engage in seven group telehealth sessions before and after their ostomy surgery, focusing on self-management techniques and addressing common challenges faced by ostomy patients. The study will assess the feasibility and preliminary efficacy of this intervention compared to standard care, with the goal of improving health-related quality of life for both patients and their family caregivers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with bladder or colorectal cancer who are scheduled for surgery involving the creation of an intestinal stoma.
Not a fit: Patients who do not have bladder or colorectal cancer or those not undergoing ostomy surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients with ostomies and their caregivers by providing effective self-management strategies.
How similar studies have performed: While telehealth interventions for chronic conditions have shown promise, this specific approach for ostomy management in cancer patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California
- City of hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Virginia Sun, PhD, RN — City of Hope Medical Center
- Study coordinator: Virginia Sun, PhD, RN
- Email: vsun@coh.org
- Phone: 626-218-3122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.