RECRUITING

The Impact of Gender Affirming Hormone Therapy on Pain In Gender Minority Adults

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

TRANSPIRE is an observational study of \~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews. Following recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.

Official Title

The Impact of Gender Affirming Hormone Therapy on Pain In Gender Minority Adults

Quick Facts

Study Start:2025-03-31
Study Completion:2029-09-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06939257

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 to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Informed consent provided by the participant
  2. * Ages 18-50 years
  3. * English speaking
  4. * GM persons who have been deemed to be an appropriate medical candidate to take gender-affirming hormone therapy for gender incongruence -OR- GM persons who are not taking gender-affirming hormone therapy
  1. * Inability to provide informed consent
  2. * Age less than 18 years or greater than 50 years
  3. * Severe physical impairment (e.g., blindness, deafness, paraplegia)
  4. * Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder)
  5. * Pregnant or nursing
  6. * Liver failure
  7. * Self-reported liver cirrhosis
  8. * Self-reported hepatitis
  9. * Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record
  10. * Prisoner
  11. * Current litigation for chronic pain
  12. * Current disability proceedings
  13. * Active psychotic or suicidal symptoms
  14. * Current drug or alcohol use disorder
  15. * History of gonadectomy surgery

Contacts and Locations

Study Contact

Emily Schulze, MSc
CONTACT
913-588-7630
FACELab@kumc.edu
Miranda McMillan, MSc
CONTACT
913-588-7630
FACELab@kumc.edu

Principal Investigator

Andrea L Chadwick, MD, MSc, FASA
PRINCIPAL_INVESTIGATOR
The University of Kansas Medical Center

Study Locations (Sites)

The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Andrea L Chadwick, MD, MSc, FASA, PRINCIPAL_INVESTIGATOR, The University of Kansas Medical Center

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 Date2025-03-31
Study Completion Date2029-09-16

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2029-09-16

Terms related to this study

Keywords Provided by Researchers

  • GHT
  • Gender Minority
  • HRT
  • Gender Affirming Hormone Therapy
  • GM

Additional Relevant MeSH Terms

  • Pain
  • Gender Minority Individuals