Clinical trial NCT03913715: Ostomy Rural Telehealth Training Cancer Survivors
Official title: Ostomy Rural Telehealth Self-management Training for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ostomy
Quality of Life
Telehealth
Keywords: Ileostomy, Urostomy, Colostomy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Activation - PAM
timeFrame: 0 months
measure: Patient Activation- PAM
timeFrame: 2 months
measure: Patient Activation - PAM
timeFrame: 3 months
measure: Patient Activation- PAM
timeFrame: 6 months
measure: Patient Activation- PAM
timeFrame: 12months
Secondary outcomes:
measure: Self-efficacy
timeFrame: 0 months
measure: Self-efficacy
timeFrame: 2 months
measure: Self-efficacy
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 0 months
measure: Health-related quality of life
timeFrame: 2 months
measure: Health-related quality of life
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Ostomy knowledge
timeFrame: 0 months
measure: Ostomy knowledge
timeFrame: 2 months
measure: Ostomy knowledge
timeFrame: 6 months
measure: Ostomy knowledge
timeFrame: 12 months
measure: Healthcare utilization long form
timeFrame: 0 months
measure: Healthcare utilization long form
timeFrame: 6 months
measure: Healthcare utilization long form
timeFrame: 12 months
measure: Healthcare utilization short form
timeFrame: 2 months
measure: Healthcare utilization short form
timeFrame: 3 months
Other outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 0 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 2 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 months
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research Center
state: North Dakota
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Greenville
country: United States
facility: University of South Carolina Greenville (Prisma Health)
state: South Carolina
Study officials:
affiliation: University of Pennsylvania
name: Robert Krouse, MD
role: PRINCIPAL_INVESTIGATOR
References: