RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05910294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
  2. * Patients are being initiated on ovarian suppression and endocrine therapy or are within 2 weeks of initiation
  3. * Women, 18 years of age or older
  4. * 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
  1. * Postmenopausal women who have been without a period for ≥ 2 years
  2. * Not initiated on both ovarian suppression and endocrine therapy
  3. * Patients who score above a 4 for urogenital symptoms or vaginal dryness at baseline as reported by baseline questionnaires (VAS and VuAS)

Contacts and Locations

Study Contact

Shari Goldfarb, MD
CONTACT
646-888-5080
goldfars@mskcc.org
Jeanne Carter, PhD
CONTACT
646-888-5076

Principal Investigator

Shari Goldfarb, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Shari Goldfarb, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Sexual Health Concerns
  • Prevention
  • Premenopausal
  • Female Breast Cancer Patients
  • Receiving Ovarian Suppression
  • 23-109

Additional Relevant MeSH Terms

  • Improve Sexual Health
  • Improve Vulvovaginal Health