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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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, 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.
City of hope Medical Center
Duarte, California, United States
RECRUITINGSelf-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.
Time frame: At 13 weeks post-randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.