N/A N=216 Randomized Health Services Research

Ostomy Telehealth For Cancer Survivors

Colostomy Stoma

Bottom Line

View on ClinicalTrials.gov: NCT02974634 ↗

Enrolled (actual)

216

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare. — 66.9; 64.2; 67.6; 66.2 score on a scale — p=0.06

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ostomy self management training (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.	66.9; 64.2; 67.6; 66.2; 70.7; 66.5	0.06
SECONDARY Self-Efficacy to Perform Ostomy Self-Management Behaviors	6.7; 7.0; 7.1; 7.3; 7.3; 7.1	0.68

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02974634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.