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

NCT ID: NCT01300663

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Study Groups

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post-surgery symptom experience

women with vulvar intraephitelial neoplasia or vulvar cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Foundation Cancer Research Switzerland

UNKNOWN

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Institute of Nursing Science, University of Basel

Locations

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University Hospital Berlin

Berlin, , Germany

Site Status RECRUITING

University Hospital Dusseldorf

Düsseldorf, , Germany

Site Status RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

University Hospital Munich

Munich, , Germany

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status NOT_YET_RECRUITING

University Hospital Berne

Bern, , Switzerland

Site Status RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Rebecca Spirig, Prof. PhD, RN

Role: CONTACT

Beate Senn, MSc, RN

Role: CONTACT

References

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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.

Reference Type RESULT
PMID: 20686386 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23290987 (View on PubMed)

Other Identifiers

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KFS 02456-08-200

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

412-09

Identifier Type: -

Identifier Source: org_study_id

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