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

Not Applicable

Active, not recruiting

• Conditions: Sexual Dysfunction; Women's Health: Neoplasm of Breast; Cancer, Breast; Menopause, Premature; Body Image
• Interventions: Behavioral: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)

• Registration Number: NCT06307470
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-12
• Study Start: 2024-10-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMBRACE Group	EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)	Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.
Delayed EMBRACE Group	EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)	After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States