NCT01300663

A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Basel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-23
• Last updated: 2011-02-23

Locations

8 sites across 2 countries: Germany, Switzerland