WISH, Feasibility of a Factorial Design

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.

• Hyaluronic acid (HLA) Vaginal Moisturizer (Device): Use of vaginal moisturizer every 3 days for weeks 1-8.
• Polycarbophil Vaginal Moisturizer (Device): Use of vaginal moisturizer every 3 days for weeks 1-8.
• Hypnotic Relaxation (Behavioral): Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
• Progressive Muscle Relaxation (PMR) (Behavioral): Listen to PMR audio file at least 3x/week for weeks 3-8.

Primary outcomes

• Accrual Rate [Screening to consent, up to 30 days.]: The number of women who consented to participate in the study divided by the number who were eligible and educated about the study.
• Retention Rate [Consent through study completion, an average of 8 weeks.]: The number of women who complete all 8 weeks of the study and complete the PROMIS SFS at baseline and at eight weeks divided by the number who are randomized and begin study treatment.
• Adherence Rate, Moisturizer [Consent through study completion, an average of 8 weeks.]: The number of moisturizer uses completed by participants divided by the total number of possible moisturizer uses.
• Adherence Rate, Relaxation Intervention [Consent through study completion, an average of 8 weeks.]: The number of times participant listened to assigned relaxation audio file (hypnosis or PMR) divided by the total number of possible listens.

Other outcomes

• Exploratory Outcome, Female Sexual Function Index (FSFI) [Consent through study completion, an average of 8 weeks.]: The Female Sexual Function Index (FSFI) is a 19-item scale that measures the following domains of female sexual functioning, followed by subscale score ranges: desire (1.2-6), arousal (0-6), satisfaction (0.8-6), orgasm (0-6), lubrication (0-6) and pain (0-6). When the scores of these domains are added together, the sum represents an FSFI total score. The possible total score from 2-36 where higher scores indicate better sexual function.
• Exploratory Outcome, PROMIS Sexual Function and Satisfaction (SFS) [Consent through study completion, an average of 8 weeks.]: The PROMIS scale is a 25 item measure that includes screener items. This study will include items asking about interest in sexual activity, lubrication, vaginal discomfort, vulvar discomfort, clitoral discomfort, orgasm and pleasure, and satisfaction. Raw scores must be converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described.
• Exploratory Outcome, Breast Impact of Treatment Scale (BITS) [Consent through study completion, an average of 8 weeks.]: The BITS scale is a 13-item measure of body change stress in women with breast cancer. Possible scores range from 0-65 where higher scores indicate greater body change stress.
• Exploratory Outcome, Sexual Distress Scale-Short Form (SDS-SF) [Consent through study completion, an average of 8 weeks.]: The SDS-SF is a 5-item scale that was developed based on the longer FSDS-R (Female Sexual Distress Scale, Revised). It is used to measure negative feelings like worry and frustration that people have about their sex lives and relationships. Possible scores range from 0-20. Higher scores indicate more of the thing being described.
• Exploratory Outcome, Scale of Body Connection (SBC) [Consent through study completion, an average of 8 weeks.]: The SBC is a 20-item scale that measures two dimensions of body connection, body awareness (BSC-BA) measured with 12 items and bodily dissociation (SBC-BD) measured with 8 items. Possible scores for body awareness range from 0-48. Possible scores for the body dissociation range from 0-32. Higher scores indicate more of the thing being described.

Sex: Female, ages: 18 Years to 99 Years

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.

• Noel M Arrign, DNP, PhD, RN, Principal investigator, College of Nursing, University of Tennessee