Women's Interventions for Sexual Health: WISH (WISH)

Women's Interventions for Sexual Health: WISH, A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction, Physiological; Body Image; Libido; Loss, Aversion
• Intervention / Treatment: Other: Hypnotic Relaxation Intervention (HRI); Device: Vulvovaginal Atrophy (VVA)

Detailed Description

Women's Interventions for Sexual Health (WISH), is a two-arm randomized clinical trial to evaluate the feasibility and acceptability of a multi-component intervention addressing changes in body image, sexual desire, and vaginal dryness in thirty adult post-treatment breast cancer survivors. The study is eight weeks long and does not require any in-person visits. If a breast cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, they will be emailed the consent form and will schedule a virtual consent/baseline visit. After consent is obtained, the participant will be randomly assigned to a study arm, HRI (hypnotic relaxation intervention plus vaginal moisturizer) or VVA (vulvovaginal atrophy moisturizer only), given a study number, and educated on the use of Replens™ vaginal moisturizer. The participant will complete online surveys at the virtual baseline visit. Replens™ vaginal moisturizer will be sent to the participant's address and receipt of the moisturizer will be confirmed by study staff before the agreed upon week one start date. The participant will use the moisturizer every day during weeks one and two and every other day during weeks three through eight. Participants randomized to the HRI group will also receive an MP3 player with three hypnotic relaxation audio files and asked to complete a weekly practice log. Each hypnotic induction audio file will be used for two weeks, three times per week, for a total of six weeks of hypnosis. A second virtual visit will be held at two weeks to assess progress, adverse events and provide education to the HRI group. Check in phone calls will be scheduled for weeks four, six and eight. A link to online follow up surveys will be shared during weeks six and eight.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carrie K Lafferty, PhD; Phone Number: 865-974-9463; Email: claffer2@utk.edu
• Study Contact Backup: Name: Noel M Arring, DNP,PhD,RN; Phone Number: 865-974-1988; Email: narring@utk.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Recruiting
      • University of Tennessee Knoxville
      • Contact: Noel M Arring, DNP,PhD,RN; Phone Number: 865-974-1988; Email: narring@utk.edu
      • Principal Investigator: Debra L Barton, PhD,RN,FAAN
      • Sub-Investigator: Noel M Arring, DNP,PhD,RN
      • Contact: Carrie K Lafferty, PhD; Phone Number: 865-974-0500; Email: claffer2@utk.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or
  2. "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotic Relaxation Intervention (HRI); 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); HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)
Other: Vulvovaginal Atrophy (VVA); 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); VVA is a standard of care intervention (Replens™ vaginal moisturizer device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen failure rate (a measure of feasibility)	The number of women screened ineligible	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 complete the 8 weeks of the study divided by the number who consented.	Baseline through study completion, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index (FSFI)	Change in FSFI score	consent to week 8
Breast- Impact of Treatment Scale (BITS)	Change in ITS score	consent to week 8
Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction	Change in PROMIS sexual function score	consent to week 8

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: Breast Cancer Research Foundation
• Investigators: Principal Investigator: Debra L Barton, PhD,RN,FAAN, University of Tennessee Knoxville

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; vulvovaginal atrophy; body image; libido
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: UTK-IRB-22-07195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data sharing requests for deidentified data as appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes