Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
18 participants
INTERVENTIONAL
2025-06-16
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Hyaluronic acid (HLA) Vaginal Moisturizer + Hypnosis
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.
Hyaluronic acid (HLA) Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Hypnotic Relaxation
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
Hyaluronic acid (HLA) Vaginal Moisturizer + PMR
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.
Hyaluronic acid (HLA) Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Progressive Muscle Relaxation (PMR)
Listen to PMR audio file at least 3x/week for weeks 3-8.
Hyaluronic acid (HLA) Vaginal Moisturizer Only
Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8.
Hyaluronic acid (HLA) Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Polycarbophil Vaginal Moisturizer + Hypnosis
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.
Polycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Hypnotic Relaxation
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
Polycarbophil Vaginal Moisturizer + PMR
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.
Polycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Progressive Muscle Relaxation (PMR)
Listen to PMR audio file at least 3x/week for weeks 3-8.
Polycarbophil Vaginal Moisturizer Only
Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8.
Polycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Interventions
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Hyaluronic acid (HLA) Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Polycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
Hypnotic Relaxation
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
Progressive Muscle Relaxation (PMR)
Listen to PMR audio file at least 3x/week for weeks 3-8.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
The University of Tennessee, Knoxville
OTHER
Responsible Party
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Principal Investigators
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Noel M Arrign, DNP, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
College of Nursing, University of Tennessee
Locations
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University of Tennessee, College of Nursing
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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UTK IRB-25-08813-XP
Identifier Type: -
Identifier Source: org_study_id
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