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

N/ACompletedNCT01903395

Martin-Luther-Universität Halle-Wittenberg313 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

313

Conditions

Colorectal Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (33)

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

Outcomes

Primary Outcomes

utilization of preventive colonoscopy

Time frame: utilization within 30 days after enrolement

Secondary Outcomes

Rate of advanced adenomas or carcinomas in situ

Time frame: Rate within 6 month after enrolement

post-operative complications associated with the colonoscopy

Time frame: within 30 days after enrolement

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.

Time frame: within 30 day after enrolement, additional at 6 months after enrolement

effectiveness and cost-effectiveness of nurse-led counselling

Time frame: within 30 days after enrolement

time delay between signed informed consent and utilization of colonoscopy

Time frame: at utilization of the colonoscopy