A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO) (WOMAN-PRO)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University of Basel.
Recruitment status was: Recruiting
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
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University Hospital Inselspital, Berne
Foundation Cancer Research Switzerland
Information provided by:
University of Basel
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.
Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer
||Creating and Validating a Patient-reported Outcome Instrument to Assess Symptom Experience Related to Surgical Wounds in Women With Vulvar Neoplasms - A Mixed Methods Study
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| Study Start Date:
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| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer