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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Hyaluronic acid (HLA) Vaginal Moisturizer Only | Experimental | Participants will use an HLA vaginal moisturizer every 3 days, weeks 1-8. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid (HLA) Vaginal Moisturizer | Device | Use of vaginal moisturizer every 3 days for weeks 1-8. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome, Female Sexual Function Index (FSFI) | 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. |
Inclusion Criteria:
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:
Exclusion Criteria:
female at birth
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| Name | Affiliation | Role |
|---|---|---|
| Noel M Arrign, DNP, PhD, RN | College of Nursing, University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee, College of Nursing | Knoxville | Tennessee | 37996 | United States |
This is a small pilot study and as such, data will be thoroughly interrogated. However, if a researcher feels there are unanswered questions or wishes to add to a larger dataset, the investigator would entertain all data-sharing requests for deidentified data as appropriate.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| 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. |
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| Polycarbophil Vaginal Moisturizer Only | Experimental | Participants will use a polycarbophil vaginal moisturizer every 3 days, weeks 1-8. |
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| Polycarbophil Vaginal Moisturizer | Device | Use of vaginal moisturizer every 3 days for weeks 1-8. |
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| Hypnotic Relaxation | Behavioral | Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8. |
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| Progressive Muscle Relaxation (PMR) | Behavioral | Listen to PMR audio file at least 3x/week for weeks 3-8. |
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| Consent through study completion, an average of 8 weeks. |
| Exploratory Outcome, PROMIS Sexual Function and Satisfaction (SFS) | 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. | Consent through study completion, an average of 8 weeks. |
| Exploratory Outcome, Breast Impact of Treatment Scale (BITS) | 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. | Consent through study completion, an average of 8 weeks. |
| Exploratory Outcome, Sexual Distress Scale-Short Form (SDS-SF) | 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. | Consent through study completion, an average of 8 weeks. |
| Exploratory Outcome, Scale of Body Connection (SBC) | 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. | Consent through study completion, an average of 8 weeks. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |