NCT03970070

Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers

Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) provides patients and their caregivers information about ostomy and ostomy care. Periop-OSMT may help to understand patient preparedness to do ostomy self-care, confidence in doing ostomy self-care, knowledge of ostomy self-care, quality of life, mood, use of medical services, and financial burden.

Detailed description

PRIMARY OBJECTIVE: I. Assess the feasibility and acceptability of the Periop-OSMT as measured by the percentage of patients and support persons/family caregivers (FCGs) who agree to participate; complete \>= 80% of the intervention; and report satisfaction with the intervention (through structured exit interviews). SECONDARY OBJECTIVES: I. Examine the patterns and trajectories for patient outcomes pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life (HRQOL), medical care utilization, and financial burden. II. Examine patterns and trajectories for support person/FCG outcomes pre- and post-intervention, including quality of life (QOL). III. Using qualitative methods, evaluate the acceptability of the intervention as reported by participants. OUTLINE: Patients and/or support persons/family caregivers complete Periop-OSMT session in-person or via telephone over 20-40 minutes before surgery and before hospital discharge, and group telehealth session over 1.5-2 hours at weeks 1-3, 4, 5, 6, and 7 post discharge. After completion of study intervention, participants are followed up for 6 months.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Informational Intervention	Complete Perioperative Ostomy Self-Management Telehealth program
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2020-01-23
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2019-05-31
• Last updated: 2023-05-16

Locations

3 sites across 1 country: United States