Clinical trial NCT01903395: Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
Official title: Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms/*drug therapy/*secondary
Health Services Accessibility
Humans
Supportive Care Needs
Psychooncology
Primary Health Care/*methods
Treatment Outcome
Socioeconomic Factors
Quality Assurance, Health Care
Adult
Aged
Aged, 80 and over
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 313
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: utilization of preventive colonoscopy
timeFrame: utilization within 30 days after enrolement
Secondary outcomes:
measure: Rate of advanced adenomas or carcinomas in situ
timeFrame: Rate within 6 month after enrolement
measure: post-operative complications associated with the colonoscopy
timeFrame: within 30 days after enrolement
measure: barriers to the use of preventive colonoscopy
timeFrame: within 30 day after enrolement, additional at 6 months after enrolement
measure: effectiveness and cost-effectiveness of nurse-led counselling
timeFrame: within 30 days after enrolement
measure: time delay between signed informed consent and utilization of colonoscopy
timeFrame: at utilization of the colonoscopy
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Würtemberg
city: Mannheim
country: Germany
facility: Diakoniekrankenhaus Mannheim
state: Baden-Würtemberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Krankenhaus Bad Cannstatt
state: Baden-Würtemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Würtemberg
city: Sigmaringen
country: Germany
facility: Kliniken Landkreis Sigmaringen GmbH
state: Baden-Württemberg
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
state: Bayern
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Würzburg
country: Germany
facility: Stiftung Juliusspital Würzburg
state: Bayern
city: Eberswalde
country: Germany
facility: Klinikum Barnim
state: Brandenburg
city: Hanau
country: Germany
facility: Klinikum Hanau
state: Hessen
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
state: Hessen
city: Schwerin
country: Germany
facility: HELIOS Kliniken Schwerin
state: Mecklenburg-Vorpommern
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
state: Niedersachsen
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
state: Niedersachsen
city: Lüneburg
country: Germany
facility: Städtisches Klinikum Lüneburg
state: Niedersachsen
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
state: Niedersachsen
city: Duisburg
country: Germany
facility: Johanniter-Krankenhaus Rheinhausen
state: Nordrhein-Westfalen
city: Gütersloh
country: Germany
facility: Sankt Elisabeth Hospital Gütersloh
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Krankenhaus Köln-Holweide
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Klinik Evang. Krankenhaus Kalk
state: Nordrhein-Westfalen
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
state: Nordrhein-Wetsfalen
city: Bad Kreuznach
country: Germany
facility: Krankenhaus St. Marienwörth
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: Diakonissen-Stiftungs-Krankenhaus Speyer
state: Rheinland-Pfalz
city: Völklingen
country: Germany
facility: Gastroenterologische Schwerpunktpraxis Völklingen
state: Saarland
city: Dessau-Roßlau
country: Germany
facility: Diakonissenkrankenhaus Dessau gemeinnützige GmbH
state: Sachsen-Anhalt
city: Lutherstadt Wittenberg
country: Germany
facility: Evangelisches Krankenhaus Paul Gerhardt Stift
state: Sachsen-Anhalt
city: Lutherstadt Wittenberg
country: Germany
facility: Praxis für Innere Medizin Dr. med. Regine Lange
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gemeinnützige GmbH
state: Sachsen-Anhalt
city: Sangerhausen
country: Germany
facility: HELIOS Klinik Sangerhausen
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
state: Sachsen
city: Heide
country: Germany
facility: Westküstenklinikum Heide
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
name: Alexander Bauer, PhD
role: PRINCIPAL_INVESTIGATOR
References: