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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-led counselling | Experimental | 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. |
|
| Usual Care | No Intervention | Usual print media, offered standardly by the recruiting centres. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led counselling | Behavioral | Nurse-led telephone counselling to double the utilization of preventive colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| utilization of preventive colonoscopy | utilization within 30 days after enrolement |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Bauer, PhD | Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Landkreis Sigmaringen GmbH | Sigmaringen | Baden-Wurttemberg | 72488 | Germany | ||
| Klinikum Ludwigsburg |
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| barriers to the use of preventive colonoscopy |
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. |
| within 30 day after enrolement, additional at 6 months after enrolement |
| 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 |
| Ludwigsburg |
| Baden-Würtemberg |
| 71640 |
| Germany |
| Diakoniekrankenhaus Mannheim | Mannheim | Baden-Würtemberg | 68163 | Germany |
| Klinikum Stuttgart Krankenhaus Bad Cannstatt | Stuttgart | Baden-Würtemberg | 70374 | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Würtemberg | 89081 | Germany |
| Klinikum Aschaffenburg | Aschaffenburg | Bavaria | 63739 | Germany |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Stiftung Juliusspital Würzburg | Würzburg | Bavaria | 97070 | Germany |
| Klinikum Barnim | Eberswalde | Brandenburg | 16225 | Germany |
| Klinikum Hanau | Hanau | Hesse | 63450 | Germany |
| Universitätsklinikum Gießen und Marburg | Marburg | Hesse | 35043 | Germany |
| Städtisches Klinikum Braunschweig | Braunschweig | Lower Saxony | 38126 | Germany |
| Allgemeines Krankenhaus Celle | Celle | Lower Saxony | 29223 | Germany |
| Städtisches Klinikum Lüneburg | Lüneburg | Lower Saxony | 21339 | Germany |
| Klinikum Osnabrück GmbH | Osnabrück | Lower Saxony | 49076 | Germany |
| HELIOS Kliniken Schwerin | Schwerin | Mecklenburg-Vorpommern | 19049 | Germany |
| Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum | Bochum | Nordrhein-Wetsfalen | 44892 | Germany |
| Krankenhaus Köln-Holweide | Cologne | North Rhine-Westphalia | 51067 | Germany |
| Klinik Evang. Krankenhaus Kalk | Cologne | North Rhine-Westphalia | 51103 | Germany |
| Johanniter-Krankenhaus Rheinhausen | Duisburg | North Rhine-Westphalia | 47228 | Germany |
| Sankt Elisabeth Hospital Gütersloh | Gütersloh | North Rhine-Westphalia | 33332 | Germany |
| Klinikum Lüdenscheid | Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
| Krankenhaus St. Marienwörth | Bad Kreuznach | Rhineland-Palatinate | 55543 | Germany |
| Diakonissen-Stiftungs-Krankenhaus Speyer | Speyer | Rhineland-Palatinate | 67346 | Germany |
| Gastroenterologische Schwerpunktpraxis Völklingen | Völklingen | Saarland | 66333 | Germany |
| Evangelisches Diakonissenkrankenhaus Leipzig gGmbH | Leipzig | Saxony | 04177 | Germany |
| Diakonissenkrankenhaus Dessau gemeinnützige GmbH | Dessau | Saxony-Anhalt | 06846 | Germany |
| Klinikum Magdeburg gemeinnützige GmbH | Magdeburg | Saxony-Anhalt | 39130 | Germany |
| HELIOS Klinik Sangerhausen | Sangerhausen | Saxony-Anhalt | 06526 | Germany |
| Evangelisches Krankenhaus Paul Gerhardt Stift | Wittenberg | Saxony-Anhalt | 06886 | Germany |
| Praxis für Innere Medizin Dr. med. Regine Lange | Wittenberg | Saxony-Anhalt | 06886 | Germany |
| Westküstenklinikum Heide | Heide | Schleswig-Holstein | 25746 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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