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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01300663
Other study ID # 412-09
Secondary ID KFS 02456-08-200
Status Recruiting
Phase N/A
First received February 22, 2011
Last updated February 22, 2011
Start date January 2009
Est. completion date December 2011

Study information

Verified date February 2011
Source University of Basel
Contact Rebecca Spirig, Prof. PhD, RN
Email Rebecca.Spirig@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Berlin Berlin
Germany University Hospital Dusseldorf Dusseldorf
Germany University Hospital Freiburg Freiburg
Germany University Hospital Munich Munich
Switzerland University Hospital Basel Basel
Switzerland University Hospital Berne Berne
Switzerland Cantonal Hospital St. Gallen St. Gallen
Switzerland University Hospital Zurich Zurich

Sponsors (3)

Lead Sponsor Collaborator
University of Basel Foundation Cancer Research Switzerland, University Hospital Inselspital, Berne

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Senn B, Mueller MD, Cignacco EL, Eicher M. Period prevalence and risk factors for postoperative short-term wound complications in vulvar cancer: a cross-sectional study. Int J Gynecol Cancer. 2010 May;20(4):646-54. doi: 10.1111/IGC.0b013e3181d92723. — View Citation