Trial Outcomes & Findings for Women's Interventions for Sexual Health: WISH (NCT NCT05692960)
NCT ID: NCT05692960
Last Updated: 2025-03-19
Results Overview
The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Up to 30 days Recruitment to screening
Results posted on
2025-03-19
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Women's Interventions for Sexual Health: WISH
Baseline characteristics by cohort
| Measure |
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
n=14 Participants
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)
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 Participants
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)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.79 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
56.94 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
55 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Sexual Orientation
Asexual
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Fluid
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Gay
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Lesbian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Queer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Straight (heterosexual)
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sexual Orientation
Prefer not to disclose
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sexual Orientation
Other not listed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education Level
Did not complete high school
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education Level
High school graduate or GED
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education Level
Some college
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Level
Undergraduate degree
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education Level
Master's degree
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education Level
Doctorate
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education Level
Prefer not to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Single, never married
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Married
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Marital status
Divorced
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Single, living with partner
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Widowed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer stage at time of diagnosis
Stage I
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cancer stage at time of diagnosis
Stage II
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cancer stage at time of diagnosis
Stage III
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days Recruitment to screeningThe number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Outcome measures
| Measure |
All Individuals Contacted
n=52 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
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)
|
|---|---|---|
|
Screen Failure Rate (a Measure of Feasibility)
|
36 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days Screening to consentThe number of participants who consented divided by the number eligible
Outcome measures
| Measure |
All Individuals Contacted
n=36 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
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)
|
|---|---|---|
|
Accrual Rate (a Measure of Feasibility)
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline through study completion, 8 weeksPopulation: The number of participants who completed all 8 weeks of the study divided by the number who were randomized.
The number of participants who completed the 8 weeks of the study divided by the number who consented.
Outcome measures
| Measure |
All Individuals Contacted
n=14 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 Participants
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)
|
|---|---|---|
|
Retention Rate/Acceptability (a Measure of Feasibility)
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: consent to week 8Population: All participants who were assigned to the study arm.
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).
Outcome measures
| Measure |
All Individuals Contacted
n=14 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 Participants
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)
|
|---|---|---|
|
Female Sexual Function Index (FSFI)
FSFI Lubrication, Baseline
|
2.06 score on a scale
Standard Deviation 1.26
|
1.65 score on a scale
Standard Deviation 1.33
|
|
Female Sexual Function Index (FSFI)
FSFI Desire, Week 8
|
3.17 score on a scale
Standard Deviation 1.09
|
3.08 score on a scale
Standard Deviation .75
|
|
Female Sexual Function Index (FSFI)
FSFI Lubrication, Week 8
|
3.90 score on a scale
Standard Deviation 1.71
|
3.92 score on a scale
Standard Deviation 1.76
|
|
Female Sexual Function Index (FSFI)
FSFI Pain, Baseline
|
2.26 score on a scale
Standard Deviation 1.58
|
1.80 score on a scale
Standard Deviation 1.54
|
|
Female Sexual Function Index (FSFI)
FSFI Desire, Baseline
|
2.06 score on a scale
Standard Deviation .84
|
2.03 score on a scale
Standard Deviation .95
|
|
Female Sexual Function Index (FSFI)
FSFI Pain, Week 8
|
3.54 score on a scale
Standard Deviation 2.13
|
3.20 score on a scale
Standard Deviation 2.23
|
|
Female Sexual Function Index (FSFI)
FSFI Total, Baseline
|
14.56 score on a scale
Standard Deviation 5.21
|
12.82 score on a scale
Standard Deviation 6.97
|
|
Female Sexual Function Index (FSFI)
FSFI Total, Week 8
|
22.35 score on a scale
Standard Deviation 8.21
|
21.44 score on a scale
Standard Deviation 7.34
|
SECONDARY outcome
Timeframe: consent to week 8Population: All participants who were assigned to the study arm.
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.
Outcome measures
| Measure |
All Individuals Contacted
n=14 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 Participants
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)
|
|---|---|---|
|
Breast Impact of Treatment Scale (BITS)
BITS, Week 8
|
19.50 units on a scale
Standard Deviation 14.85
|
28.81 units on a scale
Standard Deviation 16.67
|
|
Breast Impact of Treatment Scale (BITS)
BITS, Baseline
|
30.71 units on a scale
Standard Deviation 14.91
|
35.00 units on a scale
Standard Deviation 16.54
|
SECONDARY outcome
Timeframe: consent to week 8Population: 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.
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.
Outcome measures
| Measure |
All Individuals Contacted
n=14 Participants
Across all recruitment methods, a total of 52 individuals participated in completing a screening checklist to determine their eligibility for the study. This number is not tied to study arm. Of these 52 individuals 36 were determined to be eligible.
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 Participants
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)
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Lubrication Week 8
|
45.65 score on a scale
Standard Deviation 9.74
|
46.11 score on a scale
Standard Deviation 8.63
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Satisfaction Baseline
|
38.23 score on a scale
Standard Deviation 5.49
|
39.80 score on a scale
Standard Deviation 4.19
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Satisfaction Week 8
|
44.37 score on a scale
Standard Deviation 8.14
|
47.16 score on a scale
Standard Deviation 8.26
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Interest Week 8
|
40.34 score on a scale
Standard Deviation 11.10
|
41.48 score on a scale
Standard Deviation 7.78
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Lubrication Baseline
|
32.68 score on a scale
Standard Deviation 7.11
|
34.28 score on a scale
Standard Deviation 6.23
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )
PROMIS Interest Baseline
|
31.33 score on a scale
Standard Deviation 9.01
|
35.65 score on a scale
Standard Deviation 7.51
|
Adverse Events
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vulvovaginal Atrophy (VVA), Moisturizer Only
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
n=14 participants at risk
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)
|
Vulvovaginal Atrophy (VVA), Moisturizer Only
n=16 participants at risk
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)
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|---|---|---|
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Psychiatric disorders
Anxiety
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42.9%
6/14 • Number of events 7 • 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.
|
18.8%
3/16 • Number of events 4 • 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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Psychiatric disorders
Agitation
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7.1%
1/14 • Number of events 1 • 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.
|
18.8%
3/16 • Number of events 3 • 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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Infections and infestations
Urinary Tract Infection
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7.1%
1/14 • Number of events 1 • 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.
|
18.8%
3/16 • Number of events 5 • 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.
|
|
Infections and infestations
Sinusitus
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0.00%
0/14 • 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.
|
6.2%
1/16 • Number of events 1 • 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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Reproductive system and breast disorders
Vaginal discharge
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14.3%
2/14 • Number of events 2 • 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.
|
0.00%
0/16 • 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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Gastrointestinal disorders
Abdominal pain
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7.1%
1/14 • Number of events 1 • 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.
|
0.00%
0/16 • 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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Additional Information
Noël Arring, DNP, PhD, RN
The University of Tennessee, Knoxville
Phone: 865-974-1988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place