Clinical trial NCT02974634: Ostomy Telehealth For Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Keywords: Ileostomy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: City of Hope Medical Center
name: Yale University
name: University of Arizona
First posted: 2016-11-28
Enrollment: 216
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All cancer survivors over 21 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary).

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.
timeFrame: baseline, on completion of session ( 5 weeks) and 6 month follow up
Secondary outcomes:
measure: Self-Efficacy to Perform Ostomy Self-Management Behaviors
timeFrame: baseline, on completion of session ( 5 weeks) and 6 month follow up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert Krouse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.
citation: Sun V, Bojorquez O, Grant M, Wendel CS, Weinstein R, Krouse RS. Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis. Support Care Cancer. 2020 Apr;28(4):1551-1554. doi: 10.1007/s00520-019-05156-7. Epub 2019 Nov 13.
citation: Grant M, Sun V, Tallman NJ, Wendel CS, McCorkle R, Ercolano E, Simons C, Mo J, Raza S, Donahue D, Passero F, Henson J, MacDougall L, Friedlaender J, Pitcher P, Fry D, Yonsetto P, Holcomb MJ, Hornbrook MC, Weinstein RS, Krouse RS. Cancer survivors' greatest challenges of living with an ostomy: findings from the Ostomy Self-Management Telehealth (OSMT) randomized trial. Support Care Cancer. 2022 Feb;30(2):1139-1147. doi: 10.1007/s00520-021-06449-6. Epub 2021 Aug 26.
citation: Weinstein RS, Holcomb MJ, Mo J, Yonsetto P, Bojorquez O, Grant M, Wendel CS, Tallman NJ, Ercolano E, Cidav Z, Hornbrook MC, Sun V, McCorkle R, Krouse RS. An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial. J Med Internet Res. 2021 Sep 27;23(9):e26545. doi: 10.2196/26545.