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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Basel.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Foundation Cancer Research Switzerland
Information provided by:
University of Basel
ClinicalTrials.gov Identifier:
NCT01300663
First received: February 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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
Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Basel:

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on October 23, 2014