A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)
Recruitment status was Recruiting
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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 |
| 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 |
women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery
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| Contact: Rebecca Spirig, Prof. PhD, RN | Rebecca.Spirig@usz.ch | |
| Contact: Beate Senn, MSc, RN | Beate.Senn@unibas.ch |
| 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 | |
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:
|
Neoplasms Vulvar Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Vulvar Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013