Body Image, Breast Cancer, Sexual Desire Disorder, Vulvovaginal Signs and Symptoms
Conditions
Keywords
vulvovaginal atrophy, libido, hypnosis, progressive muscle relaxation
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.
Interventions
DEVICEHyaluronic acid (HLA) Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
DEVICEPolycarbophil Vaginal Moisturizer
Use of vaginal moisturizer every 3 days for weeks 1-8.
BEHAVIORALHypnotic Relaxation
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
BEHAVIORALProgressive Muscle Relaxation (PMR)
Listen to PMR audio file at least 3x/week for weeks 3-8.
Sponsors
The University of Tennessee, Knoxville
Breast Cancer Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNoel M Arrign, DNP, PhD, RN
College of Nursing, University of Tennessee
Outcome results
None listed