RECRUITING

Predicting Chronic Pain Following Breast Surgery

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

Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.

Official Title

Development of Predictive Models Using Artificial Intelligence for Postoperative Chronic Pain and Opioid Use Following Breast Surgery: A Prospectively-Designed Study

Quick Facts

Study Start:2021-07-19
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04967352

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. * Patient undergoing major breast surgery (except for simple lumpectomy)
  1. * refusal to consent
  2. * lack of independent decision-making capacity
  3. * inability to communicate effectively with research personnel

Contacts and Locations

Study Contact

Rodney A Gabriel, MD, MAS
CONTACT
858-663-7747
ragabriel@health.ucsd.edu

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

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 Date2021-07-19
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2021-07-19
Study Completion Date2023-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain
  • Opioid Use
  • Breast Pain
  • Breast Cancer