Colostomy Stoma Clinical Trial
The purpose of this study is to test the benefits of an educational program, the Ostomy
Self-Management Training (OSMT) program, for improving patient activation (preparedness to do
self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy
self-care, quality of life, mood, use of medical services, and financial burden in patients
with ostomies. The study will compare patients in the intervention (training) group and
patients in the usual care group.
Subjects' participation in this study is expected to last about 7 months. The PI plans to
enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School
of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be
coordinated by the University of Arizona in Tucson, Arizona.
Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates
39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of
these, at least 30,000 will receive ostomies, and an additional unknown number due to
gynecologic, other gastrointestinal tumors. The HRQOL impact is tremendous and greater than
with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling
problem for cancer survivors. The adaptation period is quite variable. 18% of participants
took at least one year, or never felt comfortable, in their ostomy care. Importantly, many
patients cannot attend selfmanagement programs or patient groups for a myriad of reasons,
including distance to travel, monetary outlays, comorbidities making travel difficult, or
lack of access to transportation. In addition, a national shortage of OCNs means patients
with an ostomy, whether newly placed or a long-term issue, receive little help.
It is imperative to study interventions for these cancer survivors aimed to limit family
financial burdens, decrease medical care use, and improve well-being. This study has the
potential to improve health care outcomes for cancer survivors with ostomies by enhancing
their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving
the ability to communicate an established educational curriculum developed based on patient
needs and desires and refined via a pilot study.
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