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Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM

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Conditions

Vulvovaginal AtrophyMenopauseGenitourinary Syndrome of MenopausePatient Reported Outcome Measure (PROM)

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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

The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of menopausal women with and without symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM).

Official Title

Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel Patient Reported Outcome Measure (PROM)

Quick Facts

Study Start:2022-09-01
Study Completion:2024-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04746456

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:45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age \> 45 years
  3. * Menopausal, defined as: \> 1 year since last menses (with a uterus, without progestin- releasing IUD, without prior endometrial ablation), or \> 6 months since bilateral oophorectomy
  4. * Pelvic exam completed as part of visit
  5. * Able to communicate in English
  1. * Chronic, bothersome vaginal symptoms before menopause (e.g. vulvar or vaginal pain, dryness, itching, discharge, discomfort with sexual activity)
  2. * History of chronic urogenital condition (vulvar, vaginal, urinary), involving pain, pruritis, discharge, or inflammation, unrelated to menopausal estrogen deficiency
  3. * History of lichen sclerosis or lichen planus
  4. * History of vulvar, vaginal or cervical cancer
  5. * Prior vulvar or vaginal surgery (office biopsy allowed)
  6. * Active major medical illness (e.g., unstable heart disease, untreated psychiatric disorder) that might interfere with the ability to participate in the study
  7. * Undiagnosed vaginal bleeding
  8. * Exam findings consistent with a urogenital condition unrelated to menopausal estrogen deficiency (e.g. yeast or BV vaginitis, vulvodynia, vulvo-vestibulitis, lichen sclerosis, lichen planus)

Contacts and Locations

Principal Investigator

Jan Shifren, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Jan Shifren, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2022-09-01
Study Completion Date2024-05-01

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2024-05-01

Terms related to this study

Keywords Provided by Researchers

  • Vulvovaginal atrophy
  • Menopause
  • Genitourinary Syndrome of Menopause
  • Patient Reported Outcome Measure (PROM)

Additional Relevant MeSH Terms

  • Vulvovaginal Atrophy
  • Menopause
  • Genitourinary Syndrome of Menopause