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

Colorectal Neoplasms Clinical Trial

— FAMKOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903395
• Other study ID #: NKP332-032
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: October 24, 2016
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg	Aschaffenburg	Bayern
Germany	Krankenhaus St. Marienwörth	Bad Kreuznach	Rheinland-Pfalz
Germany	Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum	Bochum	Nordrhein-Wetsfalen
Germany	Städtisches Klinikum Braunschweig	Braunschweig	Niedersachsen
Germany	Allgemeines Krankenhaus Celle	Celle	Niedersachsen
Germany	Diakonissenkrankenhaus Dessau gemeinnützige GmbH	Dessau-Roßlau	Sachsen-Anhalt
Germany	Johanniter-Krankenhaus Rheinhausen	Duisburg	Nordrhein-Westfalen
Germany	Klinikum Barnim	Eberswalde	Brandenburg
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Sankt Elisabeth Hospital Gütersloh	Gütersloh	Nordrhein-Westfalen
Germany	Klinikum Hanau	Hanau	Hessen
Germany	Westküstenklinikum Heide	Heide	Schleswig-Holstein
Germany	Universitätsklinikum Jena	Jena	Thüringen
Germany	Klinik Evang. Krankenhaus Kalk	Köln	Nordrhein-Westfalen
Germany	Krankenhaus Köln-Holweide	Köln	Nordrhein-Westfalen
Germany	Evangelisches Diakonissenkrankenhaus Leipzig gGmbH	Leipzig	Sachsen
Germany	Klinikum Lüdenscheid	Lüdenscheid	Nordrhein-Westfalen
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Würtemberg
Germany	Städtisches Klinikum Lüneburg	Lüneburg	Niedersachsen
Germany	Evangelisches Krankenhaus Paul Gerhardt Stift	Lutherstadt Wittenberg	Sachsen-Anhalt
Germany	Praxis für Innere Medizin Dr. med. Regine Lange	Lutherstadt Wittenberg	Sachsen-Anhalt
Germany	Klinikum Magdeburg gemeinnützige GmbH	Magdeburg	Sachsen-Anhalt
Germany	Diakoniekrankenhaus Mannheim	Mannheim	Baden-Würtemberg
Germany	Universitätsklinikum Gießen und Marburg	Marburg	Hessen
Germany	Klinikum Osnabrück GmbH	Osnabrück	Niedersachsen
Germany	HELIOS Klinik Sangerhausen	Sangerhausen	Sachsen-Anhalt
Germany	HELIOS Kliniken Schwerin	Schwerin	Mecklenburg-Vorpommern
Germany	Kliniken Landkreis Sigmaringen GmbH	Sigmaringen	Baden-Württemberg
Germany	Diakonissen-Stiftungs-Krankenhaus Speyer	Speyer	Rheinland-Pfalz
Germany	Klinikum Stuttgart Krankenhaus Bad Cannstatt	Stuttgart	Baden-Würtemberg
Germany	Universitätsklinikum Ulm	Ulm	Baden-Würtemberg
Germany	Gastroenterologische Schwerpunktpraxis Völklingen	Völklingen	Saarland
Germany	Stiftung Juliusspital Würzburg	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	utilization of preventive colonoscopy		utilization within 30 days after enrolement	Yes
Secondary	Rate of advanced adenomas or carcinomas in situ		Rate within 6 month after enrolement	Yes
Secondary	post-operative complications associated with the colonoscopy		within 30 days after enrolement	Yes
Secondary	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	No
Secondary	effectiveness and cost-effectiveness of nurse-led counselling		within 30 days after enrolement	No
Secondary	time delay between signed informed consent and utilization of colonoscopy		at utilization of the colonoscopy	No