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Completed

NCT Number: NCT02974634

Ostomy Telehealth For Cancer Survivors

The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial burden in patients with ostomies. The study will compare patients in the intervention (training) group and patients in the usual care group.

Subjects' participation in this study is expected to last about 7 months. The PI plans to enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be coordinated by the University of Arizona in Tucson, Arizona.

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Key information

Conditions

Colostomy Stoma

Age range

21 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal tumors. The HRQOL 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. 18% of participants took at least one year, or never felt comfortable, in their ostomy care. Importantly, many patients cannot attend selfmanagement programs or patient groups for a myriad of reasons, including distance to travel, monetary outlays, comorbidities making travel difficult, or lack of access to transportation. 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 these cancer survivors aimed to limit family financial burdens, decrease medical care use, and improve well-being. This study has the potential to improve health care outcomes for cancer survivors with ostomies by enhancing their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving the ability to communicate an established educational curriculum developed based on patient needs and desires and refined via a pilot study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cancer survivors over 21 years of age having undergone a procedure that needed an intestinal stoma (fecal or urinary).

Exclusion criteria

  • None

Treatment and study plan

Ostomy self management training

Other

Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Primary outcomes

  1. Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.

    Time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up

    The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)

    (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.

Secondary outcomes

  1. Self-Efficacy to Perform Ostomy Self-Management Behaviors

    Time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up

    Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.

    Range 1 to 10, where higher is better outcome

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • City of Hope Medical Center
  • University of Arizona
  • Yale University

Registry information

Acronym: PCORI

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2016
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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