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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970070
• Other study ID #: 18327
• Secondary ID: NCI-2019-0238518
• Status: Completed
• Phase: Phase 2
• Start date: January 23, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: May 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Informational Intervention
Complete Perioperative Ostomy Self-Management Telehealth program
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Banner University Medical Center - Tucson	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and family caregiver (FCG) participation	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.	Up to 24 months
Secondary	Patient reported outcomes	Will be examined pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life, medical care utilization, and financial burden. Descriptive statistics will be summarized using validated scoring procedures. The data will be used to assess descriptively the trajectory and patterns of outcomes before and after the intervention.	Up to 6 months post-discharge
Secondary	Support person/FCG reported outcomes	Will be examined pre- and post-intervention, including quality of life. Descriptive statistics will be summarized using validated scoring procedures. The data will be used to assess descriptively the trajectory and patterns of outcomes before and after the intervention.	Up to 6 months post-discharge
Secondary	Acceptability of Perioperative Ostomy Self-Management Telehealth	Acceptability will be assessed through qualitative data analysis using the conventional content analysis approach. Data from the tape-recorded interviews are transcribed and analyzed using HyperRESEARCH software. Transcripts will be imported for the development of analytic categories, data coding, and review of coded data. All data will be read repeatedly to achieve immersion and obtain a sense of the whole. Then, data will be read word by word to derive codes. Codes will be then sorted into themes based on links and relationship. Separate investigators will conduct a final validation review of the codes and themes to ensure consistency and clarity across all qualitative data. Data discordantly coded will be discussed for refinement and consensus purposes.	Up to 24 months