Study Results
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View full resultsBasic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2016-11-30
2019-08-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Ostomy Self management Training
Ostomy self-management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
Ostomy self management training
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
Usual care
Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient
Ostomy self management training
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
Interventions
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Ostomy self management training
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
110 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Yale University
OTHER
University of Arizona
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Robert Krouse, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Penn Medicine
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
Rock MC, Cidav Z, Sun V, Ercolano E, Hornbrook MC, Wendel CS, Mo J, Fellheimer H, McCorkle R, Holcomb M, Grant M, Weinstein RS, Krouse RS. Adapting to the burdens of care: a telehealth program for cancer survivors with ostomies. Support Care Cancer. 2022 Dec 14;31(1):15. doi: 10.1007/s00520-022-07461-0.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Cancer Survivors' Challenges With Ostomy Appliances and Self-Management: A Qualitative Analysis
Ostomy Telehealth for Cancer Survivors: Design of the Ostomy Self-management Training (OSMT) Randomized Trial
Other Identifiers
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826150
Identifier Type: -
Identifier Source: org_study_id
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