Study Results
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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ACTIVE_NOT_RECRUITING
1100 participants
OBSERVATIONAL
2019-02-21
2024-04-30
Brief Summary
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Detailed Description
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1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.
Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.
Descriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* FIGO stage I-IV before completion of primary therapy.
* Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).
* At least 6 months but no more than 5 years since completion of primary treatment.
* Performance status 0, 1 or 2 (WHO scale).
* Age ≥ 18 years.
* Ability to understand and fill out questionnaires.
* Written informed consent according to ICH/GCP, and national/local regulations.
Exclusion Criteria
* Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
* Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
18 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Locations
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Medical University of Graz
Graz, , Austria
ZNA Middelheim
Antwerp, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier Chretien (CHC) - CHC MontLegia
Liège, , Belgium
ZNA Jan Palfijn
Merksem, , Belgium
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal, , Germany
Ospedale San Gerardo
Monza, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
King Hussein Cancer Center
Amman, , Jordan
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, , Netherlands
UMC-Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Medical University Of Gdansk
Gdansk, , Poland
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita
Margate, Kent, United Kingdom
Northampton General Hospital NHS Trust
Cliftonville, Northampton, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, , United Kingdom
Countries
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Other Identifiers
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EORTC-1514-QLG-GCG
Identifier Type: -
Identifier Source: org_study_id
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