Telehealth Intervention for Ostomy Self-Management
NCT Number: NCT06528990
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer|Bladder Cancer
Interventions: BEHAVIORAL: Telehealth Intervention|OTHER: Standard of care
Sponsor: City of Hope Medical Center
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-01
Completion Date: 2027-07-31
Locations: City of hope Medical Center, Duarte, California, 91010, United States

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.

Primary Outcome Measures: 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: 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