Telehealth Intervention for Ostomy Self-Management

Trial Title: Telehealth Intervention for Ostomy Self-Management

NCT ID: NCT06528990

Condition: Colorectal Cancer
Bladder Cancer

Conditions: Official terms:
Colorectal Neoplasms
Urinary Bladder Neoplasms

Conditions: Keywords:
Ostomy, colorectal cancer, bladder cancer, quality of liffffffffffffffffffffe, telehealth, family caregivers

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Telehealth Intervention
Description: 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.
Arm group label: Periop-OSMT Telehealth Intervention Arm

Intervention type: Other
Intervention name: Standard of care
Description: 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.
Arm group label: Standard of Care Arm

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.

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 experience stoma-related challenges such as pain, troublesome odor, skin problems around the stoma, and leakage. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality, psychological problems, and interference with work, and recreation and sporting activities. The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention (Periop-OSMT) and to determine the preliminary efficacy of the intervention on participant-reported outcomes, compared to the usual care arm. We hypothesize that the intervention will be feasible, acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of hope Medical Center

Address:
City: Duarte
Zip: 91010
Country: United States

Contact:
Last name: Virginia Sun, PhD, RN

Phone: 626-359-8111
Email: vsun@coh.org

Start date: December 1, 2024

Completion date: July 31, 2027

Lead sponsor:
Agency: City of Hope Medical Center
Agency class: Other

Collaborator:
Agency: United States Department of Defense
Agency class: U.S. Fed

Source: City of Hope Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06528990