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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Informational Intervention; Complete Perioperative Ostomy Self-Management Telehealth program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Virginia Sun, City of Hope Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 18327 (Other Identifier: City of Hope Comprehensive Cancer Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2019-02385 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No