Recruiting
Phase 2

Telehealth Intervention

Sponsor:

City of Hope Medical Center

Code:

NCT06528990

Conditions

Colorectal Cancer

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telehealth Intervention

Standard of care

Study Details

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.

Conditions

Colorectal Cancer

Bladder Cancer

Study ID

NCT06528990

Start date

Jan 2, 2025

Status verified date

Mar, 2026

Completion date

Jun 4, 2028

Anticipated

Primary completion date

Jun 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Periop-OSMT Telehealth Intervention Arm

Arm 1 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. The intervention is delivered through 2 telephone and 5 telehealth sessions over a 16 week period.

other: Standard of Care Arm

Arm 2 involves 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.

Interventions

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.

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.

Primary outcome measure

  • Self-Efficacy for Ostomy Self-Management [ Time Frame: At 13 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Virginia Sun, PhD, RN

626-218-3122vsun@coh.org

Locations

City of hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Virginia Sun, PhD, RN

626-359-8111vsun@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Ostomy, colorectal cancer, bladder cancer, quality of liffffffffffffffffffffe, telehealth, family caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-03-05.