Clinical trial NCT05692960: Women's Interventions for Sexual Health: WISH
Official title: Women's Interventions for Sexual Health: WISH, A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction, Physiological
Body Image
Libido; Loss, Aversion
Keywords: breast cancer
vulvovaginal atrophy
libido
body image
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2023-01-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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:

  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

Primary outcomes:
measure: Screen Failure Rate (a Measure of Feasibility)
timeFrame: Up to 30 days Recruitment to screening
measure: Accrual Rate (a Measure of Feasibility)
timeFrame: Up to 30 days Screening to consent
measure: Retention Rate/Acceptability (a Measure of Feasibility)
timeFrame: Baseline through study completion, 8 weeks
Secondary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: consent to week 8
measure: Breast Impact of Treatment Scale (BITS)
timeFrame: consent to week 8
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
timeFrame: consent to week 8
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Knoxville
state: Tennessee
Study officials:
affiliation: University of Tennessee Knoxville
name: Noel M Arring, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: