A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)
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
2 other identifiers
observational
150
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 23, 2011
February 1, 2011
2.9 years
February 22, 2011
February 22, 2011
Conditions
Study Arms (1)
post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer
Eligibility Criteria
women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery
You may qualify if:
- above 18 years old
- able to read and write German
- diagnosed with vulvar neoplasms
- treated with vulval surgery during the prior six month
You may not qualify if:
- cognitive impaired
- concurrently under psychiatric treatment or terminally ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Basellead
- Insel Gruppe AG, University Hospital Berncollaborator
- Foundation Cancer Research Switzerlandcollaborator
Study Sites (8)
University Hospital Berlin
Berlin, Germany
University Hospital Dusseldorf
Düsseldorf, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
University Hospital Munich
Munich, Germany
University Hospital Basel
Basel, Switzerland
University Hospital Berne
Bern, Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
University Hospital Zurich
Zurich, Switzerland
Related Publications (2)
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.
PMID: 20686386RESULTSenn B, Eicher M, Mueller MD, Hornung R, Fink D, Baessler K, Hampl M, Denhaerynck K, Spirig R, Engberg S. A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross sectional study. Gynecol Oncol. 2013 Apr;129(1):234-40. doi: 10.1016/j.ygyno.2012.12.038. Epub 2013 Jan 3.
PMID: 23290987DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2011
First Posted
February 23, 2011
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 23, 2011
Record last verified: 2011-02