A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Improve Sexual Health, Improve Vulvovaginal Health
About this trial
This is an interventional prevention trial for Improve Sexual Health focused on measuring Sexual Health Concerns, Prevention, Premenopausal, Female Breast Cancer Patients, Receiving Ovarian Suppression, 23-109
Eligibility Criteria
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.)
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
standard of care
intervention
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.
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.