Telehealth Intervention for Ostomy Self-Management

Perioperative Ostomy Self-Management Telehealth Intervention for Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Bladder Cancer
• Intervention / Treatment: Behavioral: Telehealth Intervention; Other: Standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Virginia Sun, PhD, RN; Phone Number: 626-218-3122; Email: vsun@coh.org

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Virginia Sun, PhD, RN; Phone Number: 626-359-8111; Email: vsun@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	Will be measured by a) at least 60% of eligible participants enrolled, b) at least 60% of participants completing at least ≥80% of the intervention (at least one of sessions 1-2 and all of sessions 3-6), c) at least 60% of participants that complete any follow-up assessments after randomization, and d) exploring participant experience with the intervention through structured exit interviews).	at baseline, 13 weeks, 26 weeks post randomization
Patient Activation	Will be measured by the Patient Activation Measure (PAM). The measure assessed four stages: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Higher scores reflect higher activation. Study arm differences at 13 weeks and 26 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 and 26 weeks post-randomization
Patient and Family Caregiver Psychological Distress	Will be measured by the Distress Thermometer. The tool evaluates psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention. Study arm differences at 13 weeks and 26 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 Baseline, 13 and 26 weeks post-randomization
Quality of Life	Will be measured by the City of Hope-Quality of Life-Colorectal Cancer (COH-QOL-CRC). Evaluates overall HRQOL and four dimensions: physical, psychological, social, and spiritual well-being. Higher score reflect better quality of life. Study arm differences at 13 weeks and 26 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 Baseline, 13 and 26 weeks post-randomization
Family Caregiver Quality of Life	Will be measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) tool. Measures the FCG QOL in the physical, psychological, social, and spiritual well-being domains. Ordinal scale ranges from 0-10, with higher scores indicating better QOL. Study arm differences at 13 weeks and 26 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 Baseline, 13 and 26 weeks post-randomization
Colostomy Impact	Will be measured by the Colostomy Impact Score and used in patients with colorectal cancer only. Identifies patients with stoma dysfunction that impairs HRQOL by dividing patients into 'minor' and 'major' CI groups.	At Baseline, 13 and 26 weeks post-randomization

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Virginia Sun, PhD, RN, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): June 4, 2028
• Study Completion (Estimated): June 4, 2028

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ostomy, colorectal cancer, bladder cancer, quality of liffffffffffffffffffffe, telehealth, family caregivers
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Colorectal Neoplasms; Urinary Bladder Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 24275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No