Ostomy Rural Telehealth Self-management Training for Cancer Survivors

Who is this study for? Adult patients that have undergone a procedure that needed an intestinal stoma
What treatments are being studied? Ostomy Self-Management Training
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: No

• 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.

• Residence within a zip code that is designated as non-metropolitan or non-urban.

• All participants must have a full understanding of the protocol and be able to sign an informed consent form.

• Participants must be able to complete the study questionnaires and sessions in English.

• Having an identified caregiver/support person is NOT a requirement for eligibility but will be strongly encouraged if possible.

• All participants will attend their first training session at least six weeks after their operation.

• There is no maximum time since surgery.

• 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)

• Subjects must be willing to complete the surveys described in the protocol.

United States
University of Arkansas For Medical Sciences
Not yet recruiting
Little Rock
City Of Hope
Loma Linda University Health
Loma Linda
North Carolina
University of North Carolina
Chapel Hill
North Dakota
Sanford Research Center
New Mexico
University of New Mexico
Lancaster General Hospital
Penn Medicine
Active, not recruiting
South Carolina
University of South Carolina Greenville (Prisma Health)
Contact Information
Sabreen Raza, MPH
Time Frame
Start Date: August 1, 2019
Estimated Completion Date: February 29, 2024
Target number of participants: 208
Active Comparator: Ostomy Self-Management Training
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
Placebo Comparator: 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.
Leads: University of Pennsylvania
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials