Improve Sexual Health, Improve Vulvovaginal Health
Conditions
Keywords
Sexual Health Concerns, Prevention, Premenopausal, Female Breast Cancer Patients, Receiving Ovarian Suppression, 23-109
Brief summary
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
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.
Interventions
OTHERquestionnaires
Vaginal Assessment Scale (VAS) \& Vulvar Assessment Scale (VuAS) Breast Clinical Care and Symptom Survey (BCCSS) 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
OTHERmoisturizers
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women, 18 years of age or older * Breast cancer patients with hormone receptor positive breast cancer , stage 0-III * 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 * Patients currently on or are being initiated on ovarian suppression * Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS
Exclusion criteria
* Postmenopausal women who have been without a period for ≥ 2 years * Patients who score a 4 or above on the VAS and VuAS * Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a score of 4 or greater in VAS | 1 year | measured by the Vaginal Assessment Scale (VAS) |
Countries
United States
Contacts
CONTACTShari Goldfarb, MD
CONTACTJeanne Carter, PhD
PRINCIPAL_INVESTIGATORShari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed