Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Malignant Neoplasm
- Sponsor
- City of Hope Medical Center
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Patient and family caregiver (FCG) participation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PATIENT: Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary).
- •PATIENT: Able to read and understand English.
- •PATIENT: Patients scheduled for temporary ostomy procedures
- •SUPPORT PERSON/FCG: Family member/friend identified by the patient as the primary caregiver before and after surgery.
- •SUPPORT PERSON/FCG: Able to read and understand English.
- •Patients with all stages of disease are eligible for the study.
- •The study is open to anyone regardless of gender or ethnicity. Efforts are made to extend the accrual to a representative population.
Exclusion Criteria
- •Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
Outcomes
Primary Outcomes
Patient and family caregiver (FCG) participation
Time Frame: Up to 24 months
Assessed by ratio of eligible participants (patient and FCGs) to those enrolled and those who decline participation, reasons for non-participation, number of scheduled study encounters completed, attrition rate between pre- and post-intervention, reasons for attrition/dropout, level of intervention participation including the total number of sessions, number of sessions completed without break-offs, number of break-offs, length (minutes) of sessions, and the ratio of all participants to those who completed \>= 80% of the study.
Secondary Outcomes
- Patient reported outcomes(Up to 6 months post-discharge)
- Acceptability of Perioperative Ostomy Self-Management Telehealth(Up to 24 months)
- Support person/FCG reported outcomes(Up to 6 months post-discharge)