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

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ClinicalTrials.gov Identifier: NCT01300663
Recruitment Status : Unknown
Verified February 2011 by University of Basel.
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Foundation Cancer Research Switzerland
Information provided by:
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.

Condition or disease
Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Study Type : Observational
Estimated 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 : January 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300663


Contacts
Contact: Rebecca Spirig, Prof. PhD, RN Rebecca.Spirig@usz.ch
Contact: Beate Senn, MSc, RN Beate.Senn@unibas.ch

Locations
Germany
University Hospital Berlin Recruiting
Berlin, Germany
University Hospital Dusseldorf Recruiting
Dusseldorf, Germany
University Hospital Freiburg Recruiting
Freiburg, Germany
University Hospital Munich Recruiting
Munich, Germany
Switzerland
University Hospital Basel Not yet recruiting
Basel, Switzerland
University Hospital Berne Recruiting
Berne, Switzerland
Cantonal Hospital St. Gallen Recruiting
St. Gallen, Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Basel
University Hospital Inselspital, Berne
Foundation Cancer Research Switzerland

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Rebecca Spirig, Institute of Nursing Science, University of Basel
ClinicalTrials.gov Identifier: NCT01300663     History of Changes
Other Study ID Numbers: 412-09
KFS 02456-08-200 ( Other Grant/Funding Number: Foundation Cancer Research Switzerland, KFS 02456-08-200 )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Neoplasms
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female