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

NCT01903395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2016-10-25

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

BEHAVIORAL

Nurse-led counselling

Nurse-led telephone counselling to double the utilization of preventive colonoscopy

Sponsors & Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Principal Investigators

  • Alexander Bauer, PhD · Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903395 on ClinicalTrials.gov