WISH, Feasibility of a Factorial Design

The University of Tennessee, Knoxville

Status: Active, not recruiting

Conditions: Breast Cancer; Vulvovaginal Signs and Symptoms; Body Image; Sexual Desire Disorder

Treatments: Device: Polycarbophil Vaginal Moisturizer; Behavioral: Progressive Muscle Relaxation (PMR); Device: Hyaluronic acid (HLA) Vaginal Moisturizer; Behavioral: Hypnotic Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT07023822

UTK IRB-25-08813-XP

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis

Experimental group

Description:

Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks.

Treatment:

Behavioral: Hypnotic Relaxation

Device: Hyaluronic acid (HLA) Vaginal Moisturizer

Hyaluronic acid (HLA) Vaginal Moisturizer + PMR

Experimental group

Description:

Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks.

Treatment:

Device: Hyaluronic acid (HLA) Vaginal Moisturizer

Behavioral: Progressive Muscle Relaxation (PMR)

Hyaluronic acid (HLA) Vaginal Moisturizer Only

Experimental group

Description:

Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.

Treatment:

Device: Hyaluronic acid (HLA) Vaginal Moisturizer

Polycarbophil Vaginal Moisturizer + Hypnosis

Experimental group

Description:

Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to hypnotic relaxation audio files at least 3x/week, weeks 3-8. There are 3 audio files in total, each about 20 min in length. The files are listened to in order. Each file is used for 2 weeks.

Treatment:

Behavioral: Hypnotic Relaxation

Device: Polycarbophil Vaginal Moisturizer

Polycarbophil Vaginal Moisturizer + PMR

Experimental group

Description:

Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. Participants will listen to a progressive muscle relaxation (PMR) audio file at least 3x/week, weeks 3-8. There is only 1 PMR audio file. The same file will be used for 6 weeks.

Treatment:

Behavioral: Progressive Muscle Relaxation (PMR)

Device: Polycarbophil Vaginal Moisturizer

Polycarbophil Vaginal Moisturizer Only

Experimental group

Description:

Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.

Treatment:

Device: Polycarbophil Vaginal Moisturizer