A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

Study Overview
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Brief Summary
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Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression.

Detailed Description
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50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

Official Title
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Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression

Conditions
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Improve Sexual Health, Improve Vulvovaginal Health

Intervention / Treatment
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* Other: questionnaires
* Other: moisturizers
* Other: moisturizers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients with hormone receptor positive breast cancer , stage 0-III Patients are being initiated on ovarian suppression and endocrine therapy or are within 2 weeks of initiation Women, 18 years of age or older Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place Exclusion Criteria: Postmenopausal women who have been without a period for ≥ 2 years Not initiated on both ovarian suppression and endocrine therapy Patients who have urogenital symptoms or vaginal dryness at baseline as reported by baseline questionnaires (VAS, VuAS, PROMIS, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard of care<br>Standard of care arm will receive treatment at the time symptoms develop. Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy. | Other: questionnaires<br>* Vaginal Assessment Scale (VAS) & Vulvar Assessment Scale (VuAS) Breast survivorship Tool (MSK Engage Symptom Assessment) Female Sexual Function Index (FSFI) Sexual Activity Questionnaire (SAQ) Female Sexual Distress Scale Revised (FSDS-R) Menopausal Symptom Check List (MSCL) Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF) Weekly Non-Hormonal Moisturizer Diary<br>Other: moisturizers<br>* Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy.<br>|
| Experimental: intervention<br>Patients who are randomized to the upfront arm will receive sexual health counseling and be initiated on non-hormonal moisturizers 3-5 times per week (based on data regarding need in our patient population) at the time ovarian suppression. The upfront intervention group will also be educated about dilators and have a consultation with a pelvic floor physical therapist. Some potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules. | Other: questionnaires<br>* Vaginal Assessment Scale (VAS) & Vulvar Assessment Scale (VuAS) Breast survivorship Tool (MSK Engage Symptom Assessment) Female Sexual Function Index (FSFI) Sexual Activity Questionnaire (SAQ) Female Sexual Distress Scale Revised (FSDS-R) Menopausal Symptom Check List (MSCL) Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF) Weekly Non-Hormonal Moisturizer Diary<br>Other: moisturizers<br>* potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a score of 4 or greater in VAS | measured by the Vaginal Assessment Scale (VAS) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Health Concerns, Prevention, Premenopausal, Female Breast Cancer Patients, Receiving Ovarian Suppression, 23-109