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

October 24, 2016 updated by: Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg

Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Würtemberg
      • Ludwigsburg, Baden-Würtemberg, Germany, 71640
        • Klinikum Ludwigsburg
      • Mannheim, Baden-Würtemberg, Germany, 68163
        • Diakoniekrankenhaus Mannheim
      • Stuttgart, Baden-Würtemberg, Germany, 70374
        • Klinikum Stuttgart Krankenhaus Bad Cannstatt
      • Ulm, Baden-Würtemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Baden-Württemberg
      • Sigmaringen, Baden-Württemberg, Germany, 72488
        • Kliniken Landkreis Sigmaringen GmbH
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Klinikum Aschaffenburg
      • Erlangen, Bayern, Germany, 91054
        • Universitatsklinikum Erlangen
      • Würzburg, Bayern, Germany, 97070
        • Stiftung Juliusspital Würzburg
    • Brandenburg
      • Eberswalde, Brandenburg, Germany, 16225
        • Klinikum Barnim
    • Hessen
      • Hanau, Hessen, Germany, 63450
        • Klinikum Hanau
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinikum Giessen und Marburg
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19049
        • HELIOS Kliniken Schwerin
    • Niedersachsen
      • Braunschweig, Niedersachsen, Germany, 38126
        • Städtisches Klinikum Braunschweig
      • Celle, Niedersachsen, Germany, 29223
        • Allgemeines Krankenhaus Celle
      • Lüneburg, Niedersachsen, Germany, 21339
        • Stadtisches Klinikum Luneburg
      • Osnabrück, Niedersachsen, Germany, 49076
        • Klinikum Osnabrück GmbH
    • Nordrhein-Westfalen
      • Duisburg, Nordrhein-Westfalen, Germany, 47228
        • Johanniter-Krankenhaus Rheinhausen
      • Gütersloh, Nordrhein-Westfalen, Germany, 33332
        • Sankt Elisabeth Hospital Gütersloh
      • Köln, Nordrhein-Westfalen, Germany, 51067
        • Krankenhaus Köln-Holweide
      • Köln, Nordrhein-Westfalen, Germany, 51103
        • Klinik Evang. Krankenhaus Kalk
      • Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
        • Klinikum Lüdenscheid
    • Nordrhein-Wetsfalen
      • Bochum, Nordrhein-Wetsfalen, Germany, 44892
        • Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
        • Krankenhaus St. Marienwörth
      • Speyer, Rheinland-Pfalz, Germany, 67346
        • Diakonissen-Stiftungs-Krankenhaus Speyer
    • Saarland
      • Völklingen, Saarland, Germany, 66333
        • Gastroenterologische Schwerpunktpraxis Völklingen
    • Sachsen
      • Leipzig, Sachsen, Germany, 04177
        • Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
    • Sachsen-Anhalt
      • Dessau-Roßlau, Sachsen-Anhalt, Germany, 06846
        • Diakonissenkrankenhaus Dessau gemeinnützige GmbH
      • Lutherstadt Wittenberg, Sachsen-Anhalt, Germany, 06886
        • Evangelisches Krankenhaus Paul Gerhardt Stift
      • Lutherstadt Wittenberg, Sachsen-Anhalt, Germany, 06886
        • Praxis für Innere Medizin Dr. med. Regine Lange
      • Magdeburg, Sachsen-Anhalt, Germany, 39130
        • Klinikum Magdeburg gemeinnützige GmbH
      • Sangerhausen, Sachsen-Anhalt, Germany, 06526
        • HELIOS Klinik Sangerhausen
    • Schleswig-Holstein
      • Heide, Schleswig-Holstein, Germany, 25746
        • Westküstenklinikum Heide
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Universitätsklinikum Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Nurse-led counselling
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
No Intervention: Usual Care
Usual print media, offered standardly by the recruiting centres.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
utilization of preventive colonoscopy
Time Frame: utilization within 30 days after enrolement
utilization within 30 days after enrolement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of advanced adenomas or carcinomas in situ
Time Frame: Rate within 6 month after enrolement
Rate within 6 month after enrolement
post-operative complications associated with the colonoscopy
Time Frame: within 30 days after enrolement
within 30 days after enrolement
barriers to the use of preventive colonoscopy
Time Frame: 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.
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
within 30 days after enrolement
time delay between signed informed consent and utilization of colonoscopy
Time Frame: at utilization of the colonoscopy
at utilization of the colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKP332-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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