Clinical trial NCT03970070: Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers
Official title: Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) for Cancer Patients and Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Patient and family caregiver (FCG) participation
timeFrame: Up to 24 months
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: Up to 6 months post-discharge
measure: Support person/FCG reported outcomes
timeFrame: Up to 6 months post-discharge
measure: Acceptability of Perioperative Ostomy Self-Management Telehealth
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References: