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

City of Hope

Status and phase: Completed; Phase 2

Conditions: Malignant Neoplasm

Treatments: Other: Survey Administration; Other: Informational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03970070

18327

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2019-02385 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Health service research (Periop-OSMT)

Experimental group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Informational Intervention

Other: Survey Administration