Clinical trial NCT01300663: A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (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
Overall status: UNKNOWN
Conditions: Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Foundation Cancer Research Switzerland
First posted: 2011-02-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: women with vulvar intraephitelial neoplasia or vulvar cancer following vulvar surgery

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Hospital Berlin
city: Dusseldorf
country: Germany
facility: University Hospital Dusseldorf
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Munich
country: Germany
facility: University Hospital Munich
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Berne
country: Switzerland
facility: University Hospital Berne
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
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.
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.