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Clinical Trials/NCT06307470
NCT06307470
Completed
Not Applicable

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

University of Arkansas1 site in 1 country43 target enrollmentOctober 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Women's Health: Neoplasm of Breast
Sponsor
University of Arkansas
Enrollment
43
Locations
1
Primary Endpoint
Vulvovaginal Symptoms Questionnaire (VSQ)
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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 8 - 10 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2024
End Date
November 30, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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