Bladder Cancer Clinical Trial

Ostomy Rural Telehealth Training Cancer Survivors

Summary

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.

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Full Description

An ostomy adversely affects health-related quality of life in a diverse population of cancer survivors. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. Ostomies may be needed for other cancers related to bulky or metastatic disease, or in emergencies. In addition, ostomies may be placed on a temporary or a permanent basis. Temporary ostomies may be created in emergencies, such as perforation or obstruction due to tumor, or in planned procedures, as with a low rectal resection for cancer where an ostomy is placed to "protect" a new anastomosis while it heals. Temporary ostomies may become permanent as a result of underlying comorbidities, need for other treatments related to cancer, or poor outcome of anastomosis (leak or stricture). Peri-operative needs are the same regardless of ostomy permanence; survivors should receive clear, systematic, evidence-based ostomy self-management instruction and support.

To cope with the challenges of their diseases, cancer survivors with ostomies should have confirmed levels of self-management skills, as well as strong commitments to self-management. Cognitive restructuring, problem-solving, and self-efficacy/locus of control are essential tools for effective self-management. As in most chronic conditions, this tends to be long-term, complex, and multidimensional. Trial-and-error ostomy self-care, nurse counseling, and community referral have been the primary modes of self-management education and support in the peri-operative period. Clearly, ostomates face many obstacles in coping with their condition, not least of which is medical care that often does not meet their needs for effective information, clinical management, psychological support, and patient activation These obstacles are likely compounded for ostomates living in rural areas. Approximately 14-19% of the US population resides in rural areas. Rural cancer survivors face significant barriers to ongoing care including lack of access to specialists and cancer-specific specialized support, longer travel distances to access follow-up care, and transportation challenges due to financial barriers or lack of a vehicle. Individuals in rural areas travel a median of 51-59 minutes to reach specialized oncology care. Additionally, some studies suggest that rural cancer patients have worse quality of life and mental health than their urban counterparts, and up to a quarter of rural cancer patients have unmet cancer information needs. Telehealth delivery of an ostomy self-management program offers an opportunity to reduce these access disparities among rural ostomates.

Ostomates and their families must engage in ostomy self-management, make behavior changes, and adjust to the consequences of their condition, becoming the principal caretakers and navigators. Preparation of the survivor and unpaid designated caregiver/support person (usually family members) is requisite to assure optimal functioning and HRQOL, as well as to prevent or ameliorate ostomy-related complications and associated health care utilization. Multiple communication issues make it difficult for ostomy survivors to access resources for improving their self-management, and undermine opportunities to improve and sustain HRQOL. These resources include lack of consistent follow-up, travel issues, lack of surgeon focus on ostomy-related problems, and lack of ostomy nurse clinic resources.

Ostomies are associated with multiple HRQOL difficulties. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality psychological problems and interference with work, recreation, and sporting activities. However, improved self-efficacy eases the psychological and social burden of ostomies. No reports have been published on the results of a systematic ostomy self-management program to ensure optimal post-operative care, including adaptation, self-management, and ostomy comfort.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

N/A

Study is for people with:

Bladder Cancer

Estimated Enrollment:

208

Study ID:

NCT03913715

Recruitment Status:

Recruiting

Sponsor:

University of Pennsylvania

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There are 10 Locations for this study

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University of Arkansas For Medical Sciences
Little Rock Arkansas, 72205, United States More Info
JONATHAN LARYEA, MD FACS FASCRS FWACS
Principal Investigator
City Of Hope
Duarte California, 91010, United States More Info
Elizabeth Bustamante
Contact
626-218-3202
[email protected]
Virginia Sun, RN
Principal Investigator
Loma Linda University Health
Loma Linda California, 11005, United States More Info
Annette Boggs, BS
Contact
909-558-7251
[email protected]
Lorena Garcia
Contact
(909) 651-5612
[email protected]
Fabrizio Luca, MD, FACS, FASCRS
Principal Investigator
University of New Mexico
Albuquerque New Mexico, 87131, United States More Info
Isaac Lira
Contact
505-272-7403
[email protected]
Sarah M Popek, MD, FACS, FASCRS
Principal Investigator
University of North Carolina
Chapel Hill North Carolina, 27599, United States More Info
Dana Mueller, MPH
Contact
919-962-4671
[email protected]
Matthew Nielsen, MD
Principal Investigator
Sanford Research Center
Fargo North Dakota, 58122, United States More Info
Kevin Rittenhouse, MA
Contact
701-234-6885
[email protected]
Sabha Ganai, MD, PhD, MPH, FACS, FSSO
Principal Investigator
Geisinger
Danville Pennsylvania, 17822, United States More Info
Kirstin Kirstin Rabinowitz, MPH
Contact
570-214-1976
[email protected]
Tullika Garg, MD
Principal Investigator
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States More Info
Sara E Druck, MSN, RN, COCN
Contact
717-544-3620
[email protected]
Walid Hesham, MD
Principal Investigator
Penn Medicine
Philadelphia Pennsylvania, 19104, United States
University of South Carolina Greenville (Prisma Health)
Greenville South Carolina, 21111, United States More Info
Stacy Parkhurst, RN
Contact
864-886-1952
[email protected]
Cedrek Mcfadden, MD, FACS, FASCRS
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

208

Study ID:

NCT03913715

Recruitment Status:

Recruiting

Sponsor:


University of Pennsylvania

How clear is this clinincal trial information?

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