N/A
N=30
Women's Interventions for Sexual Health: WISH
Sexual Dysfunction, Physiological · Body Image · Libido; Loss, Aversion
Bottom Line
View on ClinicalTrials.gov: NCT05692960 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Screen Failure Rate (a Measure of Feasibility) — 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypnotic Relaxation Intervention (HRI) (Other); Vulvovaginal Atrophy (VVA) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Screen Failure Rate (a Measure of Feasibility) |
36 | — |
| PRIMARY Accrual Rate (a Measure of Feasibility) |
30 | — |
| PRIMARY Retention Rate/Acceptability (a Measure of Feasibility) |
14; 16 | — |
| SECONDARY Female Sexual Function Index (FSFI) |
14.56; 12.82; 22.35; 21.44; 2.06; 1.65 | — |
| SECONDARY Breast Impact of Treatment Scale (BITS) |
30.71; 35.00; 19.50; 28.81 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 ) |
31.33; 35.65; 40.34; 41.48; 32.68; 34.28 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05692960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.