Clinical trial · Interventional
Ostomy Rural Telehealth Training Cancer Survivors
Ostomy Rural Telehealth Self-management Training 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)
Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 43,030 rectal cancer cases and 81,190 bladder cancer cases will be diagnosed in 2018.Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal, or other gastro-urinary tumors. The health-related quality of life 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. In our R01 study, 18% of participants took at least one year to be comfortable, or never felt comfortable, in managing their ostomy care. Importantly, many patients cannot attend in-person self-management programs or patient groups for a myriad of reasons, including distance to travel, lack of access to transportation, monetary outlays, competing demands (such as work), or comorbidities making travel difficult. 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 rural survivors aimed to limit family financial burdens, improve ostomy outcomes, and improve survivors' well-being.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ostomy | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Telehealth | — | 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, skincare, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for traveling 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 (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cancer or pre-cancer (e.g. carcinoma in situ or severe dysplasia) survivors over 18 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary). Survivors with temporary ostomies will be included. 2. Residence within a zip code that is designated as non-metropolitan or non-urban. 3. All participants must have a full understanding of the protocol and be able to sign an informed consent form. 4. Participants must be able to complete the study questionnaires and sessions in English. 5. Having an identified caregiver/support person is NOT a requirement for eligibility but will be strongly encouraged if possible. 6. All participants will attend their first training session at least six weeks after their operation. 7. There is no maximum time since surgery. 8. Eligible patients with temporary ostomies must NOT undergo ostomy reversal: i. While they are participating in the training sessions (intervention arm). ii. During the corresponding time of the training sessions (usual care arm) 9. Subjects must be willing to complete the surveys described in the protocol. Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available