RECRUITING

Sex, Hormones and Identity Affect Nociceptive Expression

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 Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.

Official Title

Sex, Hormones and Identity Affect Nociceptive Expression

Quick Facts

Study Start:2023-03-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05787470

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * self-identification as one of the above gender identities
  2. * understanding of verbal and written English.
  3. * participants that have been on/off hormone treatment for at least 6 months
  1. * pain in at least 3/7 days/week for the past 3 months
  2. * HIV positive diagnosis
  3. * cardiovascular or pulmonary disease
  4. * regular use of opioid pain medications
  5. * uncontrolled hypertension (i.e. SBP/DBP of \> 150/95)
  6. * current illness accompanied by fever (body temperature \>38 °C)
  7. * prostatectomy, hysterectomy or oophorectomy
  8. * hospitalization due to psychiatric illness within the last 6 months.

Contacts and Locations

Study Contact

Tammie Quinn, BA
CONTACT
(205) 934-8743
tquinn@uab.edu

Principal Investigator

Robert Sorge, Phd
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham Department of Psychology

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Robert Sorge, Phd, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham Department of Psychology

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 Date2023-03-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pain
  • Gender Identity