Bladder or colorectal cancer patients undergoing stoma formation face a life-threatening disease, loss of an important body function, distorted body image, and require stoma appliances to contain urine or feces. Early promotion of stoma care skills is pivotal for patient adjustment to life after ostomy. However, stoma care education is not optimal due to several patient and provider factors (e.g., shorter hospital stays and staffing pressures). In addition, stoma care education following discharge is limited by the scarcity of community stoma care clinics and difficulties traveling to hospitals. Our studies to examine patients' unmet needs (R03-NCI; ACS-121193-MRSG-11-103-01-CPPB) showed significant unmet information and supportive care needs, and have resulted in the development of an intervention to facilitate post-treatment adaptation of patients with new ostomies.
The aims of this R21 study are to enhance and refine the intervention we developed (AIM 1), and to evaluate the acceptability and feasibility of the resulting Web-based program (the Mobile Ostomates REsources program; MORE;
AIM 2). The refined program will be accessible via the Internet or Android tablet. The program will include three modules: a) an educational module that provides information about stoma site selection and ostomy surgery; b) a training component that provides instructor-guided sessions on stoma care; and c) a support component that encourages psychosocial adaptation and lifestyle modification after ostomy. A multidisciplinary team, focus groups (N = 30 participants), and an iterative process of reviews and revisions, with usability testing (N = 20 participants), will be employed to refine MORE (AIM 1). We will examine the acceptability and feasibility of MORE in a randomized, two-group unbalanced design (i.e. 24 patients randomly allocated to usual care and 48 patients randomly allocated to MORE), with bladder and colorectal cancer patients scheduled for ostomy surgery (AIM 2). Patients in the intervention group will have access to MORE before and after surgery. Data will be collected one week before surgery, on the day of discharge, and four weeks thereafter. We anticipate most patients (75%) will agree to participate and that MORE will be well-accepted (AIM 2). Although this pilot study is not designed to test for group differences, we expect that, compared to patients receiving usual care, patients receiving MORE will report improved knowledge and self-care skills and reduced distress. Study results will guide further refinement of MORE for a larger experimental trial. Innovation: MORE, guided by the Individual and Family Self-Management Theory (Ryan & Sawin, 2009), utilizes cognitive, affective, and behavioral approaches to improving patients' knowledge, stoma self-care skills, and psychological adjustment. This will reduce the burden of care on the patients, family caregivers, and providers. The potential for effective dissemination of MORE via the Internet and hand-held computing devices is large. Impact: Discharging patients rapidly helps contain costs, but leaves little time for post-surgical stoma-care education. The intervention can reduce barriers to patient care and improve patient quality of life and adjustment to life after ostomy.

Public Health Relevance

There is a significant need for improving post-surgical self-care and psychosocial adaptation for the over 700,000 cancer survivors in the United States who have an ostomy (i.e., a surgically created opening in the abdomen that allows for eliminating urine or feces). In this study, we will pilot test the acceptability and feasibility of a Web-based intervention to improve stoma-related knowledge and beliefs, self-care skills, and self-regulation (e.g., distress) in bladder and colorectal cancer patients with new ostomies. The study results will guide further refinement of the ostomy education program for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21NR016518-01A1
Application #
9317866
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Matocha, Martha F
Project Start
2017-05-01
Project End
2019-04-30
Budget Start
2017-05-01
Budget End
2018-04-30
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Urology
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029