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

University of Basel

Status: Unknown

Conditions: Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01300663

412-09

KFS 02456-08-200 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

150 participants in 1 patient group

post-surgery symptom experience

Description:

women with vulvar intraephitelial neoplasia or vulvar cancer