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

February 22, 2011 updated by: University of Basel

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Berlin, Germany
        • Recruiting
        • University Hospital Berlin
      • Dusseldorf, Germany
        • Recruiting
        • University Hospital Düsseldorf
      • Freiburg, Germany
        • Recruiting
        • University Hospital Freiburg
      • Munich, Germany
        • Recruiting
        • University Hospital Munich
      • Basel, Switzerland
        • Not yet recruiting
        • University Hospital Basel
      • Berne, Switzerland
        • Recruiting
        • University Hospital Berne
      • St. Gallen, Switzerland
        • Recruiting
        • Cantonal Hospital St. Gallen
      • Zurich, Switzerland
        • Recruiting
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 412-09
  • KFS 02456-08-200 (Other Grant/Funding Number: Foundation Cancer Research Switzerland, KFS 02456-08-200)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

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