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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vulvovaginal tissue quality and symptoms, desire/energy, and relationship-partner concerns. This proposal begins the proof-of-concept pilot study in women with a history of breast cancer to deliver a multi-component intervention to improve vulvo-vaginal atrophy with a vaginal moisturizer, and sexual energy and self-image with a mind-body intervention that involves relaxation and subconscious suggestions with a hypnotic induction delivered via audio file. The primary outcome will be to evaluate the feasibility and acceptability of a multi-component intervention for sexual function. It is hypothesized that at least eighty percent of randomized participants will complete the study without differential withdraws from the control group.
Women's Interventions for Sexual Health (WISH), is a two-arm randomized clinical trial to evaluate the feasibility and acceptability of a multi-component intervention addressing changes in body image, sexual desire, and vaginal dryness in thirty adult post-treatment breast cancer survivors. The study is eight weeks long and does not require any in-person visits. If a breast cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, they will be emailed the consent form and will schedule a virtual consent/baseline visit. After consent is obtained, the participant will be randomly assigned to a study arm, HRI (hypnotic relaxation intervention plus vaginal moisturizer) or VVA (vulvovaginal atrophy moisturizer only), given a study number, and educated on the use of Replens™ vaginal moisturizer. The participant will complete online surveys at the virtual baseline visit. Replens™ vaginal moisturizer will be sent to the participant's address and receipt of the moisturizer will be confirmed by study staff before the agreed upon week one start date. The participant will use the moisturizer every day during weeks one and two and every other day during weeks three through eight. Participants randomized to the HRI group will also receive an MP3 player with three hypnotic relaxation audio files and asked to complete a weekly practice log. Each hypnotic induction audio file will be used for two weeks, three times per week, for a total of six weeks of hypnosis. A second virtual visit will be held at two weeks to assess progress, adverse events and provide education to the HRI group. Check in phone calls will be scheduled for weeks four, six and eight. A link to online follow up surveys will be shared during weeks six and eight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnotic Relaxation Intervention (HRI) | Experimental | The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm. |
|
| Vulvovaginal Atrophy (VVA) | Other | This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnotic Relaxation Intervention (HRI) | Other | HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Screen Failure Rate (a Measure of Feasibility) | The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated | Up to 30 days Recruitment to screening |
| Accrual Rate (a Measure of Feasibility) | The number of participants who consented divided by the number eligible | Up to 30 days Screening to consent |
| Retention Rate/Acceptability (a Measure of Feasibility) | The number of participants who completed the 8 weeks of the study divided by the number who consented. | Baseline through study completion, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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: desire (subscale scale = 1.2-6), arousal (subscale = 0-6), satisfaction (subscale = 0.8-6), orgasm (subscale = 0-6), lubrication (subscale = 0-6) and pain (subscale = 0-6). When the scores of these domains are added together, the sum represents an FSFI total score. The following subscales were examined in this study: FSFI total (subscale range = 2-36 where higher scores indicate better sexual function); lubrication (subscale = 0-6 where higher scores indicate greater lubrication), pain (subscale = 0-6 where lower scores indicate greater pain); and desire (subscale scale = 1.2-6 where higher scores indicate greater desire). |
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Inclusion Criteria:
History of breast cancer, stages I, II or III
Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 5 years prior to registration
May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study
May use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sex
Ability to read and write English
Able to engage in sexual activity
Currently has a sexual partner Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or pain with sexual activity?"
Responds "yes" to at least one of the following questions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel M Arring, DNP, PhD, RN | University of Tennessee Knoxville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Knoxville | Knoxville | Tennessee | 37996 | United States |
This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data sharing requests for deidentified data as appropriate.
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Participants were recruited through community recruitment efforts, social media, and ResearchMatch.org. The first participant was enrolled on February15, 2023 and the last on December 5, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis | The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm. Hypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention) |
| FG001 | Vulvovaginal Atrophy (VVA), Moisturizer Only | This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers. Vulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis | The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm. Hypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Screen Failure Rate (a Measure of Feasibility) | The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated | Posted | Count of Participants | Participants | Up to 30 days Recruitment to screening |
|
|
Adverse events were monitored every 2 weeks from week 1 to week 8.
Adverse events were assessed during bi-weekly phone calls with participants and documented using the CTCAE version 5. All participants were assessed and included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis | The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis. The vaginal moisturizer component of this arm is the same as that described for the VVA study arm. Hypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noël Arring, DNP, PhD, RN | The University of Tennessee, Knoxville | 865-974-1988 | narring@utk.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2025 | Jan 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a two-arm, randomized clinical trial.
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| Vulvovaginal Atrophy (VVA) | Device | VVA is a standard of care intervention (Replens™ vaginal moisturizer device) |
|
| consent to week 8 |
| Breast Impact of Treatment Scale (BITS) | The Breast Impact of Treatment Scale (BITS) is a 13-item scale that measures body change stress in women with breast cancer. Scores range from 0-65. Higher scores indicate greater body change stress. | consent to week 8 |
| Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 ) | The PROMIS SexF V2 is a 14-item scale that includes screener items and measures sexual activities, symptoms, functioning, and evaluation of sexual experiences. It includes the following domains: interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, orgasm and pleasure, and satisfaction. Raw scores were converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described. Researchers are encouraged to select the sexual function and satisfaction domains and items that are relevant to the specific sample being studied. In this study, the interest, satisfaction and lubrication subscales were used. | consent to week 8 |
| BG001 | Vulvovaginal Atrophy (VVA), Moisturizer Only | This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers. Vulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Cancer stage at time of diagnosis | Participant stage based on the American Joint Committee on Cancer (AJCC) Tumor-Node-Metastasis system. Stage I: the tumor is small (2 cm or less) and hasn't spread to lymph nodes. Stage II: the tumor is larger (more than 2 cm) or has spread to nearby lymph nodes. Stage III: Locally advanced breast cancer, where the cancer has spread to nearby lymph nodes and potentially to the breast tissue or chest wall. | Count of Participants | Participants |
|
|
|
| Primary | Accrual Rate (a Measure of Feasibility) | The number of participants who consented divided by the number eligible | Posted | Count of Participants | Participants | Up to 30 days Screening to consent |
|
|
|
| Primary | Retention Rate/Acceptability (a Measure of Feasibility) | The number of participants who completed the 8 weeks of the study divided by the number who consented. | The number of participants who completed all 8 weeks of the study divided by the number who were randomized. | Posted | Count of Participants | Participants | Baseline through study completion, 8 weeks |
|
|
|
| Secondary | 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: desire (subscale scale = 1.2-6), arousal (subscale = 0-6), satisfaction (subscale = 0.8-6), orgasm (subscale = 0-6), lubrication (subscale = 0-6) and pain (subscale = 0-6). When the scores of these domains are added together, the sum represents an FSFI total score. The following subscales were examined in this study: FSFI total (subscale range = 2-36 where higher scores indicate better sexual function); lubrication (subscale = 0-6 where higher scores indicate greater lubrication), pain (subscale = 0-6 where lower scores indicate greater pain); and desire (subscale scale = 1.2-6 where higher scores indicate greater desire). | All participants who were assigned to the study arm. | Posted | Mean | Standard Deviation | score on a scale | consent to week 8 |
|
|
|
|
| Secondary | Breast Impact of Treatment Scale (BITS) | The Breast Impact of Treatment Scale (BITS) is a 13-item scale that measures body change stress in women with breast cancer. Scores range from 0-65. Higher scores indicate greater body change stress. | All participants who were assigned to the study arm. | Posted | Mean | Standard Deviation | units on a scale | consent to week 8 |
|
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 ) | The PROMIS SexF V2 is a 14-item scale that includes screener items and measures sexual activities, symptoms, functioning, and evaluation of sexual experiences. It includes the following domains: interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, orgasm and pleasure, and satisfaction. Raw scores were converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described. Researchers are encouraged to select the sexual function and satisfaction domains and items that are relevant to the specific sample being studied. In this study, the interest, satisfaction and lubrication subscales were used. | All participants who were assigned to the study arm and completed PROMIS survey. The interest subscale was completed without missing data. Both the satisfaction and lubrication subscales begin with a screening question that asks "In the past 30 days, did you have any type of sexual activity?" A total of 5 participants responded "no" this item. For these subscales, total participants in HRI=13 and VVA=12. | Posted | Mean | Standard Deviation | score on a scale | consent to week 8 |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | Vulvovaginal Atrophy (VVA), Moisturizer Only | This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers. Vulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device) | 0 | 16 | 0 | 16 | 7 | 16 |
| Agitation | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Sinusitus | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| FSFI Lubrication, Baseline |
|
| FSFI Lubrication, Week 8 |
|
| FSFI Pain, Baseline |
|
| FSFI Pain, Week 8 |
|
| FSFI Desire, Baseline |
|
| FSFI Desire, Week 8 |
|
|
| FSFI Total, VVA Cohen's d |
| 1.63 |
| 2-Sided |
| 95 |
| .86 |
| 2.37 |
| Superiority |
| FSFI Lubrication, HRI Cohen's d | 1.20 | 2-Sided | 95 | .49 | 1.87 | Superiority |
| FSFI Lubrication, VVA Cohen's d | 1.85 | 2-Sided | 95 | 1.02 | 2.66 | Superiority |
| FSFI Pain, HRI Cohen's d | .77 | 2-Sided | 95 | .16 | 1.36 | Superiority |
| FSFI Pain, VVA Cohen's d | .82 | 2-Sided | 95 | .24 | 1.38 | Superiority |
| FSFI Desire, HRI Cohen's d | 1.15 | 2-Sided | 95 | .46 | 1.82 | Superiority |
| FSFI Desire, VVA Cohen's d | 1.21 | 2-Sided | 95 | .55 | 1.86 | Superiority |
| BITS, VVA Cohen's d |
| .50 |
| 2-Sided |
| 95 |
| .03 |
| 1.01 |
| Superiority |
| PROMIS Interest Week 8 |
|
|
| PROMIS Lubrication Baseline |
|
|
| PROMIS Lubrication Week 8 |
|
|
| PROMIS Satisfaction Baseline |
|
|
| PROMIS Satisfaction Week 8 |
|
|
|
| PROMIS Interest, VVA Cohen's d |
| .64 |
| 2-Sided |
| 95 |
| .09 |
| 1.18 |
| Superiority |
| PROMIS Satisfaction, HRI Cohen's d | 1.19 | 2-Sided | 95 | .45 | 1.89 | Superiority |
| PROMIS Satisfaction, VVA Cohen's d | .80 | 2-Sided | 95 | .13 | 1.44 | Superiority |
| PROMIS Lubrication, HRI Cohen's d | 1.79 | 2-Sided | 95 | .88 | 2.67 | Superiority |
| PROMIS Lubrication, VVA Cohen's d | 1.63 | 2-Sided | 95 | .74 | 2.50 | Superiority |