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

Sponsor
University of Basel (Other)
Overall Status
Unknown status
CT.gov ID
NCT01300663
Collaborator
University Hospital Inselspital, Berne (Other), Foundation Cancer Research Switzerland (Other)
150
Enrollment
8
Locations
35
Duration (Months)
18.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Official 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
    Study Start Date :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Dec 1, 2011
    Anticipated Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    post-surgery symptom experience

    women with vulvar intraephitelial neoplasia or vulvar cancer

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital Berlin Berlin Germany
      2 University Hospital Dusseldorf Dusseldorf Germany
      3 University Hospital Freiburg Freiburg Germany
      4 University Hospital Munich Munich Germany
      5 University Hospital Basel Basel Switzerland
      6 University Hospital Berne Berne Switzerland
      7 Cantonal Hospital St. Gallen St. Gallen Switzerland
      8 University Hospital Zurich Zurich Switzerland

      Sponsors and Collaborators

      • University of Basel
      • University Hospital Inselspital, Berne
      • Foundation Cancer Research Switzerland

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01300663
      Other Study ID Numbers:
      • 412-09
      • KFS 02456-08-200
      First Posted:
      Feb 23, 2011
      Last Update Posted:
      Feb 23, 2011
      Last Verified:
      Feb 1, 2011
      Additional relevant MeSH terms:
      Neoplasms
      Vulvar Neoplasms

      Study Results

      No Results Posted as of Feb 23, 2011