Clinical trial · Interventional
Ostomy Telehealth For Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colostomy Stoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ostomy self management training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ostomy Self management Training
- description
- 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
- interventionNames
- Other: Ostomy self management training
- type
- PLACEBO_COMPARATOR
- label
- Usual care
- description
- 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
- interventionNames
- Other: Ostomy self management training
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTSun 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. PMID 29051047
- RESULTSun 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. PMID 31720825
- DERIVEDRock 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. PMID 36513895
- DERIVEDGrant 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. PMID 34435212
- DERIVEDWeinstein 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. PMID 34086595