204 Participants Needed

Telehealth Training for Ostomy Patients

Recruiting at 10 trial locations
SR
MW
Overseen ByMary Wagner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ostomy Self-Management Training?

Research shows that telehealth-based Ostomy Self-management Training (OSMT) can improve self-care outcomes for ostomy patients by providing critical knowledge and support. Additionally, virtual visits have been found to be feasible and satisfactory for patients, helping them manage their ostomy care effectively.12345

Is telehealth training for ostomy patients safe?

The research on Ostomy Self-management Telehealth (OSMT) interventions, which includes telehealth training for ostomy patients, does not report any specific safety concerns related to the use of telehealth technology for this purpose.36789

How does the Ostomy Self-Management Training treatment differ from other treatments for ostomy patients?

The Ostomy Self-Management Training (OSMT) is unique because it uses telehealth to provide systematic, evidence-based education and support for ostomy patients and their caregivers, which is not commonly available in traditional care. This approach focuses on improving self-management skills and quality of life through remote access to resources and guidance, unlike the usual hit-or-miss care and community referrals.12101112

What is the purpose of this trial?

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.

Research Team

RK

Robert Krouse, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adult cancer survivors who've had surgery requiring an ostomy, living in non-urban areas. They must be at least six weeks post-operation, able to complete English questionnaires and training sessions, and consent to the study. A caregiver's support is encouraged but not mandatory.

Inclusion Criteria

There's no limit on how long ago my surgery was.
You must fully understand the study details and sign a form agreeing to participate.
You live in a rural area, far away from the city.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ostomy Self-Management Training

Participants receive training on using pouches and equipment, skincare, ostomy complications, nutritional needs, and other self-management skills via telehealth

12 months
Regular virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after the self-management training

12 months

Treatment Details

Interventions

  • Ostomy Self-Management Training
Trial Overview The trial tests Ostomy Self-Management Training via telehealth aimed at improving quality of life for rural ostomy patients. It seeks to provide a solution where in-person training isn't feasible due to distance or other barriers.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Ostomy Self-Management TrainingActive Control1 Intervention
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
Group II: Usual carePlacebo Group1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The Ostomy Self-management Training (OSMT) program is a three-year randomized trial designed to improve health-related quality of life (HRQOL) for cancer survivors with ostomies by enhancing their self-efficacy and activation through telehealth sessions led by trained nurses and peer support.
By integrating goal-setting and problem-solving strategies, the OSMT program aims to address the physical, psychological, social, and spiritual needs of participants, potentially leading to better post-operative care and support for both survivors and their caregivers.
Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial.Sun, V., Ercolano, E., McCorkle, R., et al.[2023]
The Ostomy Self-Management Telehealth program (OSMT) showed potential benefits for cancer survivors with urinary tumors, particularly for those who attended more sessions, indicating that engagement in the program may enhance self-efficacy and quality of life.
While the overall results did not show significant improvements compared to usual care, higher attendance at OSMT sessions was linked to better outcomes in self-efficacy, quality of life, and reduced anxiety, suggesting that participation level may influence the effectiveness of the intervention.
A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.Krouse, RS., Zhang, S., Wendel, CS., et al.[2023]

References

Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. [2023]
Improving Self-Care Outcomes in Ostomy Patients via Education and Standardized Discharge Criteria. [2020]
An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial. [2021]
Effects of transtheoretical model-based intervention on the self-management of patients with an ostomy: A randomised controlled trial. [2022]
Virtual Postoperative Visits for New Ostomates. [2019]
Effects of Web-Based Educational Intervention on Self-Management in Kidney Recipients. [2018]
The acceptability and outcomes of a peer- and health-professional-led Stanford self-management program for Vietnam veterans with alcohol misuse and their partners. [2019]
Asthma self-management education. [2017]
Perceptions and experiences of co-delivery model for self-management training for clinicians working with patients with long-term conditions at three healthcare economies in U.K. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized prospective trial of an ostomy telehealth intervention for cancer survivors. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Applying the Chronic Care Model to Support Ostomy Self-Management: Implications for Oncology Nursing Practice. [2018]
Development of a chronic care ostomy self-management program. [2021]
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