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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

Sponsor:

ClinicalTrials.gov Identifier:

NCT01300663

First Posted: February 23, 2011

Last Update Posted: February 23, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

University Hospital Inselspital, Berne

Foundation Cancer Research Switzerland

Information provided by:

University of Basel

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:

MedlinePlus related topics: Vulvar Cancer

Genetic and Rare Diseases Information Center resources: Vulvar Cancer

U.S. FDA Resources

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

Information from the National Library of Medicine

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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

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

More Information

Additional Information:

WOMAN-PRO - 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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Senn B, Eicher M, Mueller MD, Hornung R, Fink D, Baessler K, Hampl M, Denhaerynck K, Spirig R, Engberg S. A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross sectional study. Gynecol Oncol. 2013 Apr;129(1):234-40. doi: 10.1016/j.ygyno.2012.12.038. Epub 2013 Jan 3.


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 Submitted:	February 22, 2011
First Posted:	February 23, 2011
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

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