Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer Clinical Trial
— WOMAN-PROOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Berlin | Berlin | |
| Germany | University Hospital Dusseldorf | Dusseldorf | |
| Germany | University Hospital Freiburg | Freiburg | |
| Germany | University Hospital Munich | Munich | |
| Switzerland | University Hospital Basel | Basel | |
| Switzerland | University Hospital Berne | Berne | |
| Switzerland | Cantonal Hospital St. Gallen | St. Gallen | |
| Switzerland | University Hospital Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Basel | Foundation Cancer Research Switzerland, University Hospital Inselspital, Berne |
Germany, Switzerland,
Senn B, Mueller MD, Cignacco EL, Eicher M. Period prevalence and risk factors for postoperative short-term wound complications in vulvar cancer: a cross-sectional study. Int J Gynecol Cancer. 2010 May;20(4):646-54. doi: 10.1111/IGC.0b013e3181d92723. — View Citation