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A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO) (WOMAN-PRO)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University of Basel.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Basel
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
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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 |
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 (Adult, Senior) |
| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01300663
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:
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 ) |
| Study First Received: | February 22, 2011 |
| Last Updated: | February 22, 2011 |
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 July 26, 2017