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

• Conditions: Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

• Registration Number: NCT01300663
• Lead Sponsor: University of Basel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

University Hospital Berne; 🇨🇭 Berne, Switzerland

Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Dusseldorf; 🇩🇪 Dusseldorf, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

University Hospital Munich; 🇩🇪 Munich, Germany

University Hospital Berlin; 🇩🇪 Berlin, Germany

University Hospital Basel; 🇨🇭 Basel, Switzerland