Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
43
Sex
Women only
Ages
Ages 18 Years to 50 Years
Primary completion
2025-11-30
Last update
2025-12-26

What this trial studies

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are: 1. What is the feasibility of this intervention in an online, private setting? 2.

Conditions in scope

  • Women's Health: Neoplasm of Breast
  • Menopause, Premature
  • Body Image
  • Sexual Dysfunction
  • Cancer, Breast

Interventions

  • EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) (Behavioral) — The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for…

Who can join

Women only · Ages 18 Years to 50 Years

Inclusion criteria

  • Diagnosed with breast cancer (stages I - III) between ages 18 - 50
  • Completed active treatment (chemotherapy and/or radiation) within the last five years
  • Can read/speak English
  • Access to talk in quiet, safe environment for privacy
  • On hormonal therapies (aromatase inhibitors, tamoxifen)
  • Currently partnered (i.e., in a relationship)

Exclusion criteria

  • Currently undergoing active treatment (chemotherapy and/or radiation)
  • More than five years have passed since completing active treatment (chemotherapy and/or radiation)
  • History of advanced breast cancer (stage IV) or a breast cancer recurrence
  • Women without access to the internet
  • Cannot read/speak in English

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Little Rock Arkansas University of Arkansas for Medical Sciences Unknown

Status & timeline

  • Overall status: Completed
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2024-10-15
  • Primary completion: 2025-11-30
  • Last update posted: 2025-12-26
  • First posted: 2024-03-12

Lead sponsor: University of Arkansas (Other)

Collaborators: Intimate Pathways Center for Sexual Health

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Vulvovaginal Symptoms Questionnaire (VSQ) (Week 1, Week 16, Week 22)
    A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
  • Body Image Scale (Week 1, Week 16, Week 22)
    A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.
  • Female Sexual Functioning Index (Week 1, Week 16, Week 22)
    A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06307470 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.