Telehealth Intervention for Ostomy Self-Management

NCT06528990 | Recruiting Phase 2 DMC

• 1 other identifier: 24275
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self-Efficacy for Ostomy Self-Management

  Will be measured by the Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains: physical activity, information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management, and depression. Higher scores reflect better self-efficacy. Study arm differences at 13 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver.

  At 13 weeks post-randomization

Other Outcomes (6)

• Feasibility of the Intervention

  at baseline, 13 weeks, 26 weeks post randomization

• Patient Activation

  At 13 and 26 weeks post-randomization

• Patient and Family Caregiver Psychological Distress

  At Baseline, 13 and 26 weeks post-randomization

Study Arms (2)

Periop-OSMT Telehealth Intervention Arm

EXPERIMENTAL

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.

Behavioral: Telehealth Intervention

Standard of Care Arm

OTHER

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.

Other: Standard of care

Interventions

Telehealth Intervention BEHAVIORAL

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.

Periop-OSMT Telehealth Intervention Arm

Standard of care OTHER

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.

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

City of hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Urinary Bladder Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Virginia Sun, PhD, RN

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Sun, PhD, RN

CONTACT

626-218-3122; vsun@coh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): June 4, 2028
• Study Completion (Estimated): June 4, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)