WISH, Feasibility of a Factorial Design

NCT07023822 | Completed FDA Device

• 1 other identifier: UTK IRB-25-08813-XP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

vulvovaginal atrophy; libido; hypnosis; progressive muscle relaxation

Outcome Measures

Primary Outcomes (4)

• Accrual Rate

  The number of women who consented to participate in the study divided by the number who were eligible and educated about the study.

  Screening to consent, up to 30 days.

• Retention Rate

  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.

  Consent through study completion, an average of 8 weeks.

• Adherence Rate, Moisturizer

  The number of moisturizer uses completed by participants divided by the total number of possible moisturizer uses.

  Consent through study completion, an average of 8 weeks.

• Adherence Rate, Relaxation Intervention

  The number of times participant listened to assigned relaxation audio file (hypnosis or PMR) divided by the total number of possible listens.

  Consent through study completion, an average of 8 weeks.

Other Outcomes (5)

• Exploratory Outcome, Female Sexual Function Index (FSFI)

  Consent through study completion, an average of 8 weeks.

• Exploratory Outcome, PROMIS Sexual Function and Satisfaction (SFS)

  Consent through study completion, an average of 8 weeks.

• Exploratory Outcome, Breast Impact of Treatment Scale (BITS)

  Consent through study completion, an average of 8 weeks.

Study Arms (6)

Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis

EXPERIMENTAL

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.

Device: Hyaluronic acid (HLA) Vaginal Moisturizer; Behavioral: Hypnotic Relaxation

Hyaluronic acid (HLA) Vaginal Moisturizer + PMR

EXPERIMENTAL

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.

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

Hyaluronic acid (HLA) Vaginal Moisturizer Only

EXPERIMENTAL

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

Device: Hyaluronic acid (HLA) Vaginal Moisturizer

Polycarbophil Vaginal Moisturizer + Hypnosis

EXPERIMENTAL

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.

Device: Polycarbophil Vaginal Moisturizer; Behavioral: Hypnotic Relaxation

Polycarbophil Vaginal Moisturizer + PMR

EXPERIMENTAL

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.

Device: Polycarbophil Vaginal Moisturizer; Behavioral: Progressive Muscle Relaxation (PMR)

Polycarbophil Vaginal Moisturizer Only

EXPERIMENTAL

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

Device: Polycarbophil Vaginal Moisturizer

Interventions

Polycarbophil Vaginal Moisturizer DEVICE

Use of vaginal moisturizer every 3 days for weeks 1-8.

Polycarbophil Vaginal Moisturizer + Hypnosis; Polycarbophil Vaginal Moisturizer + PMR; Polycarbophil Vaginal Moisturizer Only

Hypnotic Relaxation BEHAVIORAL

Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.

Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis; Polycarbophil Vaginal Moisturizer + Hypnosis

Progressive Muscle Relaxation (PMR) BEHAVIORAL

Listen to PMR audio file at least 3x/week for weeks 3-8.

Hyaluronic acid (HLA) Vaginal Moisturizer + PMR; Polycarbophil Vaginal Moisturizer + PMR

Hyaluronic acid (HLA) Vaginal Moisturizer DEVICE

Use of vaginal moisturizer every 3 days for weeks 1-8.

Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis; Hyaluronic acid (HLA) Vaginal Moisturizer + PMR; Hyaluronic acid (HLA) Vaginal Moisturizer Only

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 female
• Ability to read and write English
• History of any stage of breast cancer
• 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.
• Able to engage in sexual activity including penetration or insertion into the vagina
• Currently has a sexual partner.
• Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or discomfort/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?"

You may not qualify if:

• 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.
• 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)
• Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
• Previous participant in WISH Study
• Currently receiving active treatment
• Use of oral, transdermal or vaginal estrogen
• Allergy or intolerance to Replens, Hyalo Gyn or any of their components.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of Tennessee, College of Nursing

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Histocompatibility Testing; Autogenic Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Noel M Arrign, DNP, PhD, RN

  College of Nursing, University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 17, 2025
• Study Start: June 16, 2025
• Primary Completion: October 3, 2025
• Study Completion: December 19, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)