RECRUITING

Observational Study of Ostomy Consumers

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 7-year period directly from people living with an ostomy and their caregivers (participants were re-consented with version 3 of the Protocol in 2020 which indicated a study duration of 5 years, and version 6 of the Protocol in 2025 extending for an additional 2 years). Research participants will be asked to self-report on the ostomy pouching systems they typically use and other various aspects of living with an ostomy and/or caring for an individual living with an ostomy.

Official Title

Observational Study of Ostomy Consumers

Quick Facts

Study Start:2018-10-04
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03715179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Is at least 18 years of age; any self-reported gender
  2. 2. Has a single Ileostomy, Colostomy, or Urostomy
  3. 3. Is able to provide an informed consent for study participation with no cognitive impairment that would hinder the ability to provide informed consent or provide self-reported data
  4. 4. Is willing and able to complete a once per month online questionnaire about life with an ostomy, or has a proxy who can enter data on their behalf
  5. 5. Are able to respond themselves or appoint a caregiver as a proxy to respond to online computer questionnaires in English, French Canadian, or Spanish
  6. 1. Is at least 18 years of age; any self-reported gender
  7. 2. Is an informal supporter (such as a relative, friend, or neighbor) of the care recipient
  8. 3. Provides support to the care recipient in some capacity (such as ordering supplies or pouch changes) on average at least once per week
  1. 1. Has more than one stoma
  2. 2. Has a single stoma that has been reversed or closed

Contacts and Locations

Study Contact

Manager Global Clinical Affairs
CONTACT
+18479321845
mackenzie.juckett@hollister.com

Principal Investigator

Renee Malandrino, MSN RN CWOCN
PRINCIPAL_INVESTIGATOR
Hollister Incorporated

Study Locations (Sites)

Hollister Incorporated
Libertyville, Illinois, 60048
United States

Collaborators and Investigators

Sponsor: Hollister Incorporated

  • Renee Malandrino, MSN RN CWOCN, PRINCIPAL_INVESTIGATOR, Hollister Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-04
Study Completion Date2027-02

Study Record Updates

Study Start Date2018-10-04
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Ostomy