Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
FAMKOL
Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
1 other identifier
interventional
313
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 25, 2016
October 1, 2016
3.8 years
July 11, 2013
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
utilization of preventive colonoscopy
utilization within 30 days after enrolement
Secondary Outcomes (5)
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
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
Study Arms (2)
Nurse-led counselling
EXPERIMENTALFirst-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.
Usual Care
NO INTERVENTIONUsual print media, offered standardly by the recruiting centres.
Interventions
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
Eligibility Criteria
You may qualify if:
- aged 18 and over
- being first-degree relatives of patients with diagnosed colorectal cancer
- able to understand German
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Kliniken Landkreis Sigmaringen GmbH
Sigmaringen, Baden-Wurttemberg, 72488, Germany
Klinikum Ludwigsburg
Ludwigsburg, Baden-Würtemberg, 71640, Germany
Diakoniekrankenhaus Mannheim
Mannheim, Baden-Würtemberg, 68163, Germany
Klinikum Stuttgart Krankenhaus Bad Cannstatt
Stuttgart, Baden-Würtemberg, 70374, Germany
Universitätsklinikum Ulm
Ulm, Baden-Würtemberg, 89081, Germany
Klinikum Aschaffenburg
Aschaffenburg, Bavaria, 63739, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Stiftung Juliusspital Würzburg
Würzburg, Bavaria, 97070, Germany
Klinikum Barnim
Eberswalde, Brandenburg, 16225, Germany
Klinikum Hanau
Hanau, Hesse, 63450, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Hesse, 35043, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38126, Germany
Allgemeines Krankenhaus Celle
Celle, Lower Saxony, 29223, Germany
Städtisches Klinikum Lüneburg
Lüneburg, Lower Saxony, 21339, Germany
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, 49076, Germany
HELIOS Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19049, Germany
Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
Bochum, Nordrhein-Wetsfalen, 44892, Germany
Krankenhaus Köln-Holweide
Cologne, North Rhine-Westphalia, 51067, Germany
Klinik Evang. Krankenhaus Kalk
Cologne, North Rhine-Westphalia, 51103, Germany
Johanniter-Krankenhaus Rheinhausen
Duisburg, North Rhine-Westphalia, 47228, Germany
Sankt Elisabeth Hospital Gütersloh
Gütersloh, North Rhine-Westphalia, 33332, Germany
Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515, Germany
Krankenhaus St. Marienwörth
Bad Kreuznach, Rhineland-Palatinate, 55543, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Rhineland-Palatinate, 67346, Germany
Gastroenterologische Schwerpunktpraxis Völklingen
Völklingen, Saarland, 66333, Germany
Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
Leipzig, Saxony, 04177, Germany
Diakonissenkrankenhaus Dessau gemeinnützige GmbH
Dessau, Saxony-Anhalt, 06846, Germany
Klinikum Magdeburg gemeinnützige GmbH
Magdeburg, Saxony-Anhalt, 39130, Germany
HELIOS Klinik Sangerhausen
Sangerhausen, Saxony-Anhalt, 06526, Germany
Evangelisches Krankenhaus Paul Gerhardt Stift
Wittenberg, Saxony-Anhalt, 06886, Germany
Praxis für Innere Medizin Dr. med. Regine Lange
Wittenberg, Saxony-Anhalt, 06886, Germany
Westküstenklinikum Heide
Heide, Schleswig-Holstein, 25746, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Bauer, PhD
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 19, 2013
Study Start
March 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 25, 2016
Record last verified: 2016-10