Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
NCT ID: NCT01903395
Last Updated: 2016-10-25
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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COMPLETED
NA
313 participants
INTERVENTIONAL
2012-03-31
2015-12-31
Brief Summary
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AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.
METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Nurse-led counselling
First-degree relatives of patients undergoing active treatment for colorectal cancer are offered a nurse-led counselling by telephone regarding emotional and cognitive barriers to screening utilization.
Nurse-led counselling
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
Usual Care
Usual print media, offered standardly by the recruiting centres.
No interventions assigned to this group
Interventions
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Nurse-led counselling
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
Eligibility Criteria
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Inclusion Criteria
* being first-degree relatives of patients with diagnosed colorectal cancer
* able to understand German
Exclusion Criteria
* utilization of diagnostic colonoscopy within the past 5 years
* being ever treated for colorectal cancer
* actual inflammatory bowl disease
* comorbidities associated with reduced further life expectancy (ECOG performance status \>3
45 Years
ALL
Yes
Sponsors
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Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Alexander Bauer
PhD
Principal Investigators
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Alexander Bauer, PhD
Role: PRINCIPAL_INVESTIGATOR
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Locations
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Kliniken Landkreis Sigmaringen GmbH
Sigmaringen, Baden-Wurttemberg, Germany
Klinikum Ludwigsburg
Ludwigsburg, Baden-Würtemberg, Germany
Diakoniekrankenhaus Mannheim
Mannheim, Baden-Würtemberg, Germany
Klinikum Stuttgart Krankenhaus Bad Cannstatt
Stuttgart, Baden-Würtemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Würtemberg, Germany
Klinikum Aschaffenburg
Aschaffenburg, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Stiftung Juliusspital Würzburg
Würzburg, Bavaria, Germany
Klinikum Barnim
Eberswalde, Brandenburg, Germany
Klinikum Hanau
Hanau, Hesse, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Hesse, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, Germany
Allgemeines Krankenhaus Celle
Celle, Lower Saxony, Germany
Städtisches Klinikum Lüneburg
Lüneburg, Lower Saxony, Germany
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, Germany
HELIOS Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
Bochum, Nordrhein-Wetsfalen, Germany
Krankenhaus Köln-Holweide
Cologne, North Rhine-Westphalia, Germany
Klinik Evang. Krankenhaus Kalk
Cologne, North Rhine-Westphalia, Germany
Johanniter-Krankenhaus Rheinhausen
Duisburg, North Rhine-Westphalia, Germany
Sankt Elisabeth Hospital Gütersloh
Gütersloh, North Rhine-Westphalia, Germany
Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, Germany
Krankenhaus St. Marienwörth
Bad Kreuznach, Rhineland-Palatinate, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Rhineland-Palatinate, Germany
Gastroenterologische Schwerpunktpraxis Völklingen
Völklingen, Saarland, Germany
Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
Leipzig, Saxony, Germany
Diakonissenkrankenhaus Dessau gemeinnützige GmbH
Dessau, Saxony-Anhalt, Germany
Klinikum Magdeburg gemeinnützige GmbH
Magdeburg, Saxony-Anhalt, Germany
HELIOS Klinik Sangerhausen
Sangerhausen, Saxony-Anhalt, Germany
Evangelisches Krankenhaus Paul Gerhardt Stift
Wittenberg, Saxony-Anhalt, Germany
Praxis für Innere Medizin Dr. med. Regine Lange
Wittenberg, Saxony-Anhalt, Germany
Westküstenklinikum Heide
Heide, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Countries
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Other Identifiers
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NKP332-032
Identifier Type: -
Identifier Source: org_study_id
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