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

NCT03970070 | Completed Phase 2 DMC

• 3 other identifiers: 18327NCI-2019-02385P30CA033572
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient reported outcomes

  Up to 6 months post-discharge

• Support person/FCG reported outcomes

  Up to 6 months post-discharge

• Acceptability of Perioperative Ostomy Self-Management Telehealth

  Up to 24 months

Study Arms (1)

Health service research (Periop-OSMT)

EXPERIMENTAL

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

Interventions

Informational Intervention OTHER

Complete Perioperative Ostomy Self-Management Telehealth program

Health service research (Periop-OSMT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Health service research (Periop-OSMT)

Questionnaire Administration OTHER

Ancillary studies

Health service research (Periop-OSMT)

Survey Administration OTHER

Ancillary studies

Health service research (Periop-OSMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Virginia Sun

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 31, 2019
• Study Start: January 23, 2020
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

US (3)