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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01300663
Acronym
WOMAN-PRO
Enrollment
150
Registered
2011-02-23
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

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.

Interventions

None listed

Sponsors

Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
Foundation Cancer Research Switzerland
CollaboratorUNKNOWN
University of Basel
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Germany, Switzerland

Contacts

Primary ContactRebecca Spirig, Prof. PhD, RN
Rebecca.Spirig@usz.ch
Backup ContactBeate Senn, MSc, RN
Beate.Senn@unibas.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026