Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Neoplasms

• 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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• aged 18 and over
• being first-degree relatives of patients with diagnosed colorectal cancer
• able to understand German

Exclusion Criteria

• 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

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 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

Kliniken Landkreis Sigmaringen GmbH; 🇩🇪 Sigmaringen, Baden-Württemberg, Germany

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Bayern, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bayern, Germany

Stiftung Juliusspital Würzburg; 🇩🇪 Würzburg, Bayern, Germany

Klinikum Barnim; 🇩🇪 Eberswalde, Brandenburg, Germany

Klinikum Hanau; 🇩🇪 Hanau, Hessen, Germany

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