RECRUITINGPhase 2INTERVENTIONAL

Telehealth Intervention for Ostomy Self-Management

Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors

About This Trial

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.

Who May Be Eligible (Plain English)

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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Telehealth Intervention

This includes the following key components: 1) assignment to a peer ostomate; 2) ostomy self-management skills building delivered through group telehealth sessions and led by trained ostomy nurses and peer ostomates; 3) intervention resource manual.

OTHER

Standard of care

standard of care, where patients and family caregivers are managed by the oncology care team. Care may include clinic visits for follow-up, cancer directed treatments, referrals to other medical specialties as needed, and institutional ostomy nurse support before and after surgery as needed.

Locations (1)

City of hope Medical Center

Duarte, California, United States