Clinical trial · Interventional
Women's Interventions for Sexual Health: WISH
Women's Interventions for Sexual Health: WISH, A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image | — | UNRESOLVED | — |
| Libido; Loss, Aversion | — | UNRESOLVED | — |
| Sexual Dysfunction, Physiological | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnotic Relaxation Intervention (HRI) | Other | — | UNRESOLVED |
| Vulvovaginal Atrophy (VVA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypnotic Relaxation Intervention (HRI)
- description
- 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.
- interventionNames
- Other: Hypnotic Relaxation Intervention (HRI)
- type
- OTHER
- label
- Vulvovaginal Atrophy (VVA)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available