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

Primary Purpose

Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital BerlinRecruiting
  • University Hospital DusseldorfRecruiting
  • University Hospital FreiburgRecruiting
  • University Hospital MunichRecruiting
  • University Hospital Basel
  • University Hospital BerneRecruiting
  • Cantonal Hospital St. GallenRecruiting
  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

post-surgery symptom experience

Arm Description

women with vulvar intraephitelial neoplasia or vulvar cancer

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 22, 2011
Last Updated
February 22, 2011
Sponsor
University of Basel
Collaborators
Insel Gruppe AG, University Hospital Bern, Foundation Cancer Research Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01300663
Brief Title
A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)
Acronym
WOMAN-PRO
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
Study Type
Observational

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Basel
Collaborators
Insel Gruppe AG, University Hospital Bern, Foundation Cancer Research Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

7. Study Design

Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
post-surgery symptom experience
Arm Description
women with vulvar intraephitelial neoplasia or vulvar cancer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Spirig, Prof. PhD, RN
Email
Rebecca.Spirig@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Beate Senn, MSc, RN
Email
Beate.Senn@unibas.ch
Facility Information:
Facility Name
University Hospital Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Dusseldorf
City
Dusseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Munich
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Berne
City
Berne
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Cantonal Hospital St. Gallen
City
St. Gallen
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
20686386
Citation
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.
Results Reference
result
PubMed Identifier
23290987
Citation
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.
Results Reference
derived

Learn more about this trial

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

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