Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers
NCT ID: NCT03970070
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
2020-01-23
2021-05-12
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Health service research (Periop-OSMT)
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
Informational Intervention
Complete Perioperative Ostomy Self-Management Telehealth program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Informational Intervention
Complete Perioperative Ostomy Self-Management Telehealth program
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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Banner University Medical Center - Tucson
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2019-02385
Identifier Type: REGISTRY
Identifier Source: secondary_id
18327
Identifier Type: OTHER
Identifier Source: secondary_id
18327
Identifier Type: -
Identifier Source: org_study_id
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