- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300663
A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO) (WOMAN-PRO)
February 22, 2011 updated by: University of Basel
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
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca Spirig, Prof. PhD, RN
- Email: Rebecca.Spirig@usz.ch
Study Contact Backup
- Name: Beate Senn, MSc, RN
- Email: Beate.Senn@unibas.ch
Study Locations
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Berlin, Germany
- Recruiting
- University Hospital Berlin
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Dusseldorf, Germany
- Recruiting
- University Hospital Düsseldorf
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Freiburg, Germany
- Recruiting
- University Hospital Freiburg
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Munich, Germany
- Recruiting
- University Hospital Munich
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Basel, Switzerland
- Not yet recruiting
- University Hospital Basel
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Berne, Switzerland
- Recruiting
- University Hospital Berne
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St. Gallen, Switzerland
- Recruiting
- Cantonal Hospital St. Gallen
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Zurich, Switzerland
- Recruiting
- University Hospital Zurich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
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post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 22, 2011
First Posted (Estimate)
February 23, 2011
Study Record Updates
Last Update Posted (Estimate)
February 23, 2011
Last Update Submitted That Met QC Criteria
February 22, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 412-09
- KFS 02456-08-200 (Other Grant/Funding Number: Foundation Cancer Research Switzerland, KFS 02456-08-200)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer
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St.Gallen University of Applied SciencesMedical University of Vienna; University Hospital Inselspital, Berne; University... and other collaboratorsCompletedVulvar Cancer | Vulvar Intraepithelial NeoplasiaSwitzerland
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Northwestern UniversityNational Cancer Institute (NCI)WithdrawnCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2 | Cervical Intraepithelial Neoplasia Grade 3 | Stage III Vulvar Cancer | Recurrent Cervical Cancer | Recurrent Vaginal Cancer | Recurrent Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vaginal Cancer | Stage 0 Vulvar... and other conditions
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University of ManchesterBritish Society for the Study of Vulval DiseaseCompletedVulvar Cancer | Lichen Planus | Vulvar Lichen Sclerosus | Self-Examination | Vulval Intraepithelial Neoplasia | Vulval Cancer | Vulval Intraepithelial Neoplasia With Lichen SclerosusUnited Kingdom
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingCervical Intraepithelial Neoplasia | Cervical Adenocarcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Vaginal Adenocarcinoma | Vulvar Intraepithelial Neoplasia | Stage I Cervical Cancer AJCC v8 | Stage IA Cervical Cancer AJCC v8 | Stage IA1 Cervical Cancer AJCC v8 | Stage IA2 Cervical... and other conditionsUnited States
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Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...RecruitingCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina
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Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...RecruitingCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina
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Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...Active, not recruitingCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina
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Xiamen Innovax Biotech Co., LtdJiangsu Province Centers for Disease Control and Prevention; Dongtai City Centers...CompletedCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina
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Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...CompletedCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina
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Jun ZhangXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...CompletedA Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent GirlsCervical Cancer | Cervical Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | Persistent InfectionChina