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NCT Number: NCT06307470

Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors

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. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?

Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

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Key information

Conditions

Women's Health: Neoplasm of Breast Adnexal Diseases Body Image Breast Diseases Breast Neoplasms Cancer, Breast Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menopause, Premature Neoplasms Neoplasms by Site Ovarian Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.

The solution-focused tools will include vaginal rehydration and dilation products with vaginal lubrication. Tools will be distributed via mail by Session 2.

Primary outcomes

  1. Vulvovaginal Symptoms Questionnaire (VSQ)

    Time frame: 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.

  2. Body Image Scale

    Time frame: 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.

  3. Female Sexual Functioning Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Intimate Pathways Center for Sexual Health

Registry information

Official study title

Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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