A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)
Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer
Conditions: official terms
Vulvar Neoplasms
Study Type
Study Phase
Study Design
Overall Status
Post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia and vulvar cancer) are still high and an instrument assessing patients self-reported post-vulval surgery symptom experiences is missing. The study aims to develop and validate a postoperative instrument to assess symptom experiences in women with vulvar neoplasms. In this mixed-method project 20 patients were interviewed, a WOMAN-PRO instrument was developed and content validity was tested by 6 experts and 10 patients. The instrument's psychometric properties and the prevalence of symptoms will be examined in a cross-sectional study in the University Hospitals Munich, Freiburg, Berlin, Düsseldorf, Zurich, Basel, Berne, and the Cantonal Hospital St. Gallen (N=150). The goal of this project is that symptom assessment becomes a standard component of clinical practice (to promote the early detection and treatment of symptoms) and research.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- above 18 years old

- able to read and write German

- diagnosed with vulvar neoplasms

- treated with vulval surgery during the prior six month

Exclusion Criteria:

- cognitive impaired

- concurrently under psychiatric treatment or terminally ill
University Hospital Berlin
Berlin, Germany
Status: Recruiting
University Hospital Dusseldorf
Dusseldorf, Germany
Status: Recruiting
University Hospital Freiburg
Freiburg, Germany
Status: Recruiting
University Hospital Munich
Munich, Germany
Status: Recruiting
University Hospital Basel
Basel, Switzerland
Status: Not yet recruiting
University Hospital Berne
Berne, Switzerland
Status: Recruiting
Cantonal Hospital St. Gallen
St. Gallen, Switzerland
Status: Recruiting
University Hospital Zurich
Zurich, Switzerland
Status: Recruiting
Start Date
January 2009
Completion Date
December 2011
University of Basel
University of Basel
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page