Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT05692960
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Women's Interventions for Sexual Health: WISH
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'narring@utk.edu', 'phone': '865-974-1988', 'title': 'Noël Arring, DNP, PhD, RN', 'organization': 'The University of Tennessee, Knoxville'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored every 2 weeks from week 1 to week 8.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinusitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Screen Failure Rate (a Measure of Feasibility)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Individuals Contacted', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days Recruitment to screening', 'description': 'The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Accrual Rate (a Measure of Feasibility)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Individuals Contacted', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days Screening to consent', 'description': 'The number of participants who consented divided by the number eligible', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention Rate/Acceptability (a Measure of Feasibility)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'OG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through study completion, 8 weeks', 'description': 'The number of participants who completed the 8 weeks of the study divided by the number who consented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who completed all 8 weeks of the study divided by the number who were randomized.'}, {'type': 'SECONDARY', 'title': 'Female Sexual Function Index (FSFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'OG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}], 'classes': [{'title': 'FSFI Total, Baseline', 'categories': [{'measurements': [{'value': '14.56', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '12.82', 'spread': '6.97', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Total, Week 8', 'categories': [{'measurements': [{'value': '22.35', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '21.44', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Lubrication, Baseline', 'categories': [{'measurements': [{'value': '2.06', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Lubrication, Week 8', 'categories': [{'measurements': [{'value': '3.90', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Pain, Baseline', 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Pain, Week 8', 'categories': [{'measurements': [{'value': '3.54', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Desire, Baseline', 'categories': [{'measurements': [{'value': '2.06', 'spread': '.84', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '.95', 'groupId': 'OG001'}]}]}, {'title': 'FSFI Desire, Week 8', 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': "FSFI Total, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '.62', 'ciUpperLimit': '2.10', 'groupDescription': "Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.", 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.'}, {'groupIds': ['OG001'], 'paramType': "FSFI Total, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '.86', 'ciUpperLimit': '2.37', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': "FSFI Lubrication, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '.49', 'ciUpperLimit': '1.87', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': "FSFI Lubrication, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.66', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': "FSFI Pain, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.77', 'ciLowerLimit': '.16', 'ciUpperLimit': '1.36', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': "FSFI Pain, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.82', 'ciLowerLimit': '.24', 'ciUpperLimit': '1.38', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': "FSFI Desire, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '.46', 'ciUpperLimit': '1.82', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': "FSFI Desire, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '.55', 'ciUpperLimit': '1.86', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'consent to week 8', 'description': '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.\n\nThe 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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the study arm.'}, {'type': 'SECONDARY', 'title': 'Breast Impact of Treatment Scale (BITS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'OG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}], 'classes': [{'title': 'BITS, Baseline', 'categories': [{'measurements': [{'value': '30.71', 'spread': '14.91', 'groupId': 'OG000'}, {'value': '35.00', 'spread': '16.54', 'groupId': 'OG001'}]}]}, {'title': 'BITS, Week 8', 'categories': [{'measurements': [{'value': '19.50', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '28.81', 'spread': '16.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': "BITS, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '.34', 'ciUpperLimit': '1.63', 'groupDescription': "Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.", 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.'}, {'groupIds': ['OG001'], 'paramType': "BITS, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.50', 'ciLowerLimit': '.03', 'ciUpperLimit': '1.01', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'consent to week 8', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to the study arm.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'OG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}], 'classes': [{'title': 'PROMIS Interest Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.33', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '35.65', 'spread': '7.51', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Interest Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.34', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '41.48', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Lubrication Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.68', 'spread': '7.11', 'groupId': 'OG000'}, {'value': '34.28', 'spread': '6.23', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Lubrication Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.65', 'spread': '9.74', 'groupId': 'OG000'}, {'value': '46.11', 'spread': '8.63', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Satisfaction Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.23', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '39.80', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Satisfaction Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.37', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '47.16', 'spread': '8.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': "PROMIS Interest, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '.41', 'ciUpperLimit': '1.75', 'groupDescription': "Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.", 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.'}, {'groupIds': ['OG001'], 'paramType': "PROMIS Interest, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.64', 'ciLowerLimit': '.09', 'ciUpperLimit': '1.18', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': "PROMIS Satisfaction, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '.45', 'ciUpperLimit': '1.89', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': "PROMIS Satisfaction, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.80', 'ciLowerLimit': '.13', 'ciUpperLimit': '1.44', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': "PROMIS Lubrication, HRI Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '.88', 'ciUpperLimit': '2.67', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': "PROMIS Lubrication, VVA Cohen's d", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '.74', 'ciUpperLimit': '2.50', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'consent to week 8', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'FG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.\n\nHypnotic Relaxation Intervention (HRI): HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)'}, {'id': 'BG001', 'title': 'Vulvovaginal Atrophy (VVA), Moisturizer Only', 'description': '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.\n\nVulvovaginal Atrophy (VVA): VVA is a standard of care intervention (Replens™ vaginal moisturizer device)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.79', 'spread': '10.82', 'groupId': 'BG000'}, {'value': '56.94', 'spread': '10.83', 'groupId': 'BG001'}, {'value': '55', 'spread': '10.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sexual Orientation', 'classes': [{'categories': [{'title': 'Asexual', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Bisexual', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Fluid', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Gay', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Lesbian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Pansexual', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Queer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Straight (heterosexual)', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Prefer not to disclose', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other not listed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'title': 'Did not complete high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'High school graduate or GED', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Undergraduate degree', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': "Master's degree", 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Doctorate', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'categories': [{'title': 'Single, never married', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Married', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Divorced', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Single, living with partner', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer stage at time of diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Stage II', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "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.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-07', 'size': 312714, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-24T15:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a two-arm, randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2022-12-14', 'resultsFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-14', 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screen Failure Rate (a Measure of Feasibility)', 'timeFrame': 'Up to 30 days Recruitment to screening', 'description': 'The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated'}, {'measure': 'Accrual Rate (a Measure of Feasibility)', 'timeFrame': 'Up to 30 days Screening to consent', 'description': 'The number of participants who consented divided by the number eligible'}, {'measure': 'Retention Rate/Acceptability (a Measure of Feasibility)', 'timeFrame': 'Baseline through study completion, 8 weeks', 'description': 'The number of participants who completed the 8 weeks of the study divided by the number who consented.'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'consent to week 8', 'description': '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.\n\nThe 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).'}, {'measure': 'Breast Impact of Treatment Scale (BITS)', 'timeFrame': 'consent to week 8', 'description': '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.'}, {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )', 'timeFrame': 'consent to week 8', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['breast cancer', 'vulvovaginal atrophy', 'libido', 'body image'], 'conditions': ['Sexual Dysfunction, Physiological', 'Body Image', 'Libido; Loss, Aversion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of breast cancer, stages I, II or III\n* Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 5 years prior to registration\n* May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study\n* May use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sex\n* Ability to read and write English\n* Able to engage in sexual activity\n* Currently has a sexual partner Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or pain with sexual activity?"\n* Responds "yes" to at least one of the following questions:\n\n 1. "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or\n 2. "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"\n\nExclusion Criteria:\n\n* 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\n* History of sexual abuse\n* Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report)\n* Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)\n* Use of oral, transdermal or vaginal estrogen is not allowed while on study'}, 'identificationModule': {'nctId': 'NCT05692960', 'acronym': 'WISH', 'briefTitle': "Women's Interventions for Sexual Health: WISH", 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': "Women's Interventions for Sexual Health: WISH, A Pilot Study", 'orgStudyIdInfo': {'id': 'UTK-IRB-22-07195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnotic Relaxation Intervention (HRI)', 'description': '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.\n\nThe vaginal moisturizer component of this arm is the same as that described for the VVA study arm.', 'interventionNames': ['Other: Hypnotic Relaxation Intervention (HRI)']}, {'type': 'OTHER', 'label': 'Vulvovaginal Atrophy (VVA)', 'description': '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.', 'interventionNames': ['Device: Vulvovaginal Atrophy (VVA)']}], 'interventions': [{'name': 'Hypnotic Relaxation Intervention (HRI)', 'type': 'OTHER', 'description': 'HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)', 'armGroupLabels': ['Hypnotic Relaxation Intervention (HRI)']}, {'name': 'Vulvovaginal Atrophy (VVA)', 'type': 'DEVICE', 'description': 'VVA is a standard of care intervention (Replens™ vaginal moisturizer device)', 'armGroupLabels': ['Vulvovaginal Atrophy (VVA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Noel M Arring, DNP, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee Knoxville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Breast Cancer Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}