Ostomy Rural Telehealth Training Cancer Survivors

Running, not enrolling · Not applicable

Conditions studied: Ostomy, Quality of Life, Telehealth

In brief

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.

Key facts

Study ID

NCT03913715

Run by

Abramson Cancer Center at Penn Medicine

People needed

204

Starts

2019-08-01

Expected to finish

2026-10-31

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• N/A

Where it is running

• University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States
• City Of Hope — Duarte, California, United States
• Loma Linda University Health — Loma Linda, California, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Sanford Research Center — Fargo, North Dakota, United States
• Geisinger — Danville, Pennsylvania, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Penn Medicine — Philadelphia, Pennsylvania, United States
• University of South Carolina Greenville (Prisma Health) — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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