Clinical trial NCT07023822: WISH, Feasibility of a Factorial Design
Official title: Women's Interventions for Sexual Health: WISH, Feasibility of a Factorial Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Vulvovaginal Signs and Symptoms
Sexual Desire Disorder
Body Image
Keywords: vulvovaginal atrophy
libido
hypnosis
progressive muscle relaxation
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2025-06-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a feasibility of a factorial design testing a multi-component intervention to improve vulvovaginal atrophy, sexual desire and body image. The investigators will also explore effect sizes of the chosen outcome measures to gather preliminary efficacy data.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

Detailed description: This proposal builds upon a multi-component pilot study (WISH), where women with a history of breast cancer participated in a two-component intervention to improve vulvovaginal atrophy with a vaginal moisturizer and sexual desire and body image with Hypnotic Relaxation (HR), a mind-body intervention that includes suggestions for relaxation, improved sexual desire, and body image delivered via audio file. This study seeks to further test WISH by expanding vulvovaginal atrophy interventions to include either a polycarbophil-based vaginal moisturizer (Replens™) or a hyaluronic acid-based moisturizer (HYALO GYN ®); and hypnosis relaxation (HR) or progressive muscle relaxation (PMR) interventions for sexual desire and body image. The primary outcome is the feasibility of a multi-component intervention for sexual function using a factorial design.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 female
2. Ability to read and write English
3. History of any stage of breast cancer
4. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. Participants may use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
5. Able to engage in sexual activity including penetration or insertion into the vagina
6. Currently has a sexual partner.
7. Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?"
8. 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:

1. 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.
2. An active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, PTSD, schizophrenia or borderline personality disorder (Defined per medical history and/or patient self-report)
3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
4. Previous participant in WISH Study
5. Currently receiving active treatment
6. Use of oral, transdermal or vaginal estrogen
7. Allergy or intolerance to Replens, Hyalo Gyn or any of their components.

Primary outcomes:
measure: Accrual Rate
timeFrame: Screening to consent, up to 30 days.
measure: Retention Rate
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Adherence Rate, Moisturizer
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Adherence Rate, Relaxation Intervention
timeFrame: Consent through study completion, an average of 8 weeks.
Secondary outcomes:
Other outcomes:
measure: Exploratory Outcome, Female Sexual Function Index (FSFI)
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Exploratory Outcome, PROMIS Sexual Function and Satisfaction (SFS)
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Exploratory Outcome, Breast Impact of Treatment Scale (BITS)
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Exploratory Outcome, Sexual Distress Scale-Short Form (SDS-SF)
timeFrame: Consent through study completion, an average of 8 weeks.
measure: Exploratory Outcome, Scale of Body Connection (SBC)
timeFrame: Consent through study completion, an average of 8 weeks.
Locations:
Study officials:
affiliation: College of Nursing, University of Tennessee
name: Noel M Arrign, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: