Women's Interventions for Sexual Health: WISH

NCT05692960 | Completed Results FDA Device

• 1 other identifier: UTK-IRB-22-07195
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vulvovaginal tissue quality and symptoms, desire/energy, and relationship-partner concerns. This proposal begins the proof-of-concept pilot study in women with a history of breast cancer to deliver a multi-component intervention to improve vulvo-vaginal atrophy with a vaginal moisturizer, and sexual energy and self-image with a mind-body intervention that involves relaxation and subconscious suggestions with a hypnotic induction delivered via audio file. The primary outcome will be to evaluate the feasibility and acceptability of a multi-component intervention for sexual function. It is hypothesized that at least eighty percent of randomized participants will complete the study without differential withdraws from the control group.

Conditions

Sexual Dysfunction, Physiological; Body Image; Libido; Loss, Aversion

Keywords

breast cancer; vulvovaginal atrophy; libido; body image

Outcome Measures

Primary Outcomes (3)

• Screen Failure Rate (a Measure of Feasibility)

  The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated

  Up to 30 days Recruitment to screening

• Accrual Rate (a Measure of Feasibility)

  The number of participants who consented divided by the number eligible

  Up to 30 days Screening to consent

• Retention Rate/Acceptability (a Measure of Feasibility)

  The number of participants who completed the 8 weeks of the study divided by the number who consented.

  Baseline through study completion, 8 weeks

Secondary Outcomes (3)

• Female Sexual Function Index (FSFI)

  consent to week 8

• Breast Impact of Treatment Scale (BITS)

  consent to week 8

• Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )

  consent to week 8

Study Arms (2)

Hypnotic Relaxation Intervention (HRI)

EXPERIMENTAL

The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.

Other: Hypnotic Relaxation Intervention (HRI)

Vulvovaginal Atrophy (VVA)

OTHER

This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.

Device: Vulvovaginal Atrophy (VVA)

Interventions

Hypnotic Relaxation Intervention (HRI) OTHER

HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)

Hypnotic Relaxation Intervention (HRI)

Vulvovaginal Atrophy (VVA) DEVICE

VVA is a standard of care intervention (Replens™ vaginal moisturizer device)

Vulvovaginal Atrophy (VVA)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of breast cancer, stages I, II or III
• Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 5 years prior to registration
• May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study
• May use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sex
• Ability to read and write English
• Able to engage in sexual activity
• Currently has a sexual partner Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or pain with sexual activity?"
• Responds "yes" to at least one of the following questions:
• "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or
• "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"

You may not qualify if:

• Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change
• History of sexual abuse
• Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report)
• Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)
• Use of oral, transdermal or vaginal estrogen is not allowed while on study

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of Tennessee Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Noël Arring, DNP, PhD, RN
• Organization: The University of Tennessee, Knoxville

narring@utk.edu

865-974-1988

Study Officials

• Noel M Arring, DNP, PhD, RN

  University of Tennessee Knoxville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, randomized clinical trial.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 20, 2023
• Study Start: February 15, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)