A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO) (WOMAN-PRO)
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ClinicalTrials.gov Identifier: NCT01300663 |
Recruitment Status
: Unknown
Verified February 2011 by University of Basel.
Recruitment status was: Recruiting
First Posted
: February 23, 2011
Last Update Posted
: February 23, 2011
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Condition or disease |
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Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer |
Study Type : | Observational |
Estimated Enrollment : | 150 participants |
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 Start Date : | January 2009 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2011 |

Group/Cohort |
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post-surgery symptom experience
women with vulvar intraephitelial neoplasia or vulvar cancer
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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 |
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

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
Contact: Rebecca Spirig, Prof. PhD, RN | Rebecca.Spirig@usz.ch | ||
Contact: Beate Senn, MSc, RN | Beate.Senn@unibas.ch |
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 |
Publications of Results:
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 ) |
First Posted: | February 23, 2011 Key Record Dates |
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 |