RECRUITING

Adolescent Outcomes of Post-operative Opioid EXposure

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 goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.

Official Title

Adolescent Outcomes of Post-operative Opioid EXposure

Quick Facts

Study Start:2024-11-12
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06350409

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:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sharon Levy, MD, MPH
CONTACT
857-218-4308
sharon.levy@childrens.harvard.edu
Joesph Cravero, MD
CONTACT
Joesph.Cravero@childrens.harvard.edu

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
United States
Boston Childrens Hopsital - Division of Addiction Medicine
Boston, Massachusetts, 02115
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Sharon Levy

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 Date2024-11-12
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Adolescent Opioid Use
  • Post operative pain

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Pain, Chronic