N/A
Completed N=30
Women's Interventions for Sexual Health: WISH
Sexual Dysfunction, Physiological · Body Image · Libido; Loss, Aversion
Source: ClinicalTrials.gov NCT05692960 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Screen Failure Rate (a Measure of Feasibility) — 36 Participants
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.
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 | — |
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. Informational only — not medical advice.