Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- Behavioral: Nurse-led counselling
- Registration Number
- NCT01903395
- Lead Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Brief Summary
BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. Nevertheless, participation in the German national screening program stagnates at 2-3 percent per year even in this high-risk population.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
- aged 18 and over
- being first-degree relatives of patients with diagnosed colorectal cancer
- able to understand German
- Familial Adenomatous Polyposis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nurse-led counselling 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.
- Primary Outcome Measures
Name Time Method utilization of preventive colonoscopy utilization within 30 days after enrolement
- Secondary Outcome Measures
Name Time Method Rate of advanced adenomas or carcinomas in situ Rate within 6 month after enrolement post-operative complications associated with the colonoscopy within 30 days after enrolement barriers to the use of preventive colonoscopy within 30 day after enrolement, additional at 6 months after enrolement Barriers against preventive colonoscopy are very common among the healthy population. Such barriers can bei either of cognitive (e.g. being afraid of the potential diagnosis) or emotional nature (e.g. shame to be exposed naked to the examiners).
Barriers are assessed by Barriers Questionnaire-II (BQ-II) during telephone counselling.effectiveness and cost-effectiveness of nurse-led counselling within 30 days after enrolement time delay between signed informed consent and utilization of colonoscopy at utilization of the colonoscopy
Trial Locations
- Locations (33)
Klinikum Barnim
🇩🇪Eberswalde, Brandenburg, Germany
Kliniken Landkreis Sigmaringen GmbH
🇩🇪Sigmaringen, Baden-Württemberg, Germany
Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Bayern, Germany
Krankenhaus St. Marienwörth
🇩🇪Bad Kreuznach, Rheinland-Pfalz, Germany
Diakonissenkrankenhaus Dessau gemeinnützige GmbH
🇩🇪Dessau-Roßlau, Sachsen-Anhalt, Germany
Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
🇩🇪Leipzig, Sachsen, Germany
Gastroenterologische Schwerpunktpraxis Völklingen
🇩🇪Völklingen, Saarland, Germany
Universitätsklinikum Gießen und Marburg
🇩🇪Marburg, Hessen, Germany
Städtisches Klinikum Braunschweig
🇩🇪Braunschweig, Niedersachsen, Germany
Allgemeines Krankenhaus Celle
🇩🇪Celle, Niedersachsen, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
🇩🇪Speyer, Rheinland-Pfalz, Germany
HELIOS Kliniken Schwerin
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Städtisches Klinikum Lüneburg
🇩🇪Lüneburg, Niedersachsen, Germany
Johanniter-Krankenhaus Rheinhausen
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Stiftung Juliusspital Würzburg
🇩🇪Würzburg, Bayern, Germany
Sankt Elisabeth Hospital Gütersloh
🇩🇪Gütersloh, Nordrhein-Westfalen, Germany
Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
🇩🇪Bochum, Nordrhein-Wetsfalen, Germany
Diakoniekrankenhaus Mannheim
🇩🇪Mannheim, Baden-Würtemberg, Germany
Klinikum Stuttgart Krankenhaus Bad Cannstatt
🇩🇪Stuttgart, Baden-Würtemberg, Germany
Klinikum Hanau
🇩🇪Hanau, Hessen, Germany
Klinikum Lüdenscheid
🇩🇪Lüdenscheid, Nordrhein-Westfalen, Germany
HELIOS Klinik Sangerhausen
🇩🇪Sangerhausen, Sachsen-Anhalt, Germany
Krankenhaus Köln-Holweide
🇩🇪Köln, Nordrhein-Westfalen, Germany
Klinikum Osnabrück GmbH
🇩🇪Osnabrück, Niedersachsen, Germany
Westküstenklinikum Heide
🇩🇪Heide, Schleswig-Holstein, Germany
Evangelisches Krankenhaus Paul Gerhardt Stift
🇩🇪Lutherstadt Wittenberg, Sachsen-Anhalt, Germany
Praxis für Innere Medizin Dr. med. Regine Lange
🇩🇪Lutherstadt Wittenberg, Sachsen-Anhalt, Germany
Klinikum Magdeburg gemeinnützige GmbH
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Würtemberg, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Baden-Würtemberg, Germany
Klinik Evang. Krankenhaus Kalk
🇩🇪Köln, Nordrhein-Westfalen, Germany