Women's Interventions for Sexual Health: WISH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: Hypnotic Relaxation Intervention (HRI)
* Device: Vulvovaginal Atrophy (VVA)


Participation Criteria
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Eligibility Criteria
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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: 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? 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm, randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, vulvovaginal atrophy, libido, body image