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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nurse-led counselling
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring 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

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Klinikum Ludwigsburg
  • Diakoniekrankenhaus Mannheim
  • Klinikum Stuttgart Krankenhaus Bad Cannstatt
  • Universitätsklinikum Ulm
  • Kliniken Landkreis Sigmaringen GmbH
  • Klinikum Aschaffenburg
  • Universitätsklinikum Erlangen
  • Stiftung Juliusspital Würzburg
  • Klinikum Barnim
  • Klinikum Hanau
  • Universitätsklinikum Gießen und Marburg
  • HELIOS Kliniken Schwerin
  • Städtisches Klinikum Braunschweig
  • Allgemeines Krankenhaus Celle
  • Städtisches Klinikum Lüneburg
  • Klinikum Osnabrück GmbH
  • Johanniter-Krankenhaus Rheinhausen
  • Sankt Elisabeth Hospital Gütersloh
  • Krankenhaus Köln-Holweide
  • Klinik Evang. Krankenhaus Kalk
  • Klinikum Lüdenscheid
  • Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
  • Krankenhaus St. Marienwörth
  • Diakonissen-Stiftungs-Krankenhaus Speyer
  • Gastroenterologische Schwerpunktpraxis Völklingen
  • Diakonissenkrankenhaus Dessau gemeinnützige GmbH
  • Evangelisches Krankenhaus Paul Gerhardt Stift
  • Praxis für Innere Medizin Dr. med. Regine Lange
  • Klinikum Magdeburg gemeinnützige GmbH
  • HELIOS Klinik Sangerhausen
  • Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
  • Westküstenklinikum Heide
  • Universitätsklinikum Jena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nurse-led counselling

Usual Care

Arm Description

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.

Usual print media, offered standardly by the recruiting centres.

Outcomes

Primary Outcome Measures

utilization of preventive colonoscopy

Secondary Outcome Measures

Rate of advanced adenomas or carcinomas in situ
post-operative complications associated with the colonoscopy
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.
effectiveness and cost-effectiveness of nurse-led counselling
time delay between signed informed consent and utilization of colonoscopy

Full Information

First Posted
July 11, 2013
Last Updated
October 24, 2016
Sponsor
Martin-Luther-Universität Halle-Wittenberg
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1. Study Identification

Unique Protocol Identification Number
NCT01903395
Brief Title
Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
Acronym
FAMKOL
Official Title
Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led counselling
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual print media, offered standardly by the recruiting centres.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led counselling
Intervention Description
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
Primary Outcome Measure Information:
Title
utilization of preventive colonoscopy
Time Frame
utilization within 30 days after enrolement
Secondary Outcome Measure Information:
Title
Rate of advanced adenomas or carcinomas in situ
Time Frame
Rate within 6 month after enrolement
Title
post-operative complications associated with the colonoscopy
Time Frame
within 30 days after enrolement
Title
barriers to the use of preventive colonoscopy
Description
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.
Time Frame
within 30 day after enrolement, additional at 6 months after enrolement
Title
effectiveness and cost-effectiveness of nurse-led counselling
Time Frame
within 30 days after enrolement
Title
time delay between signed informed consent and utilization of colonoscopy
Time Frame
at utilization of the colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Bauer, PhD
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
State/Province
Baden-Würtemberg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Diakoniekrankenhaus Mannheim
City
Mannheim
State/Province
Baden-Würtemberg
ZIP/Postal Code
68163
Country
Germany
Facility Name
Klinikum Stuttgart Krankenhaus Bad Cannstatt
City
Stuttgart
State/Province
Baden-Würtemberg
ZIP/Postal Code
70374
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Würtemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Kliniken Landkreis Sigmaringen GmbH
City
Sigmaringen
State/Province
Baden-Württemberg
ZIP/Postal Code
72488
Country
Germany
Facility Name
Klinikum Aschaffenburg
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Stiftung Juliusspital Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
Klinikum Barnim
City
Eberswalde
State/Province
Brandenburg
ZIP/Postal Code
16225
Country
Germany
Facility Name
Klinikum Hanau
City
Hanau
State/Province
Hessen
ZIP/Postal Code
63450
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
HELIOS Kliniken Schwerin
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19049
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38126
Country
Germany
Facility Name
Allgemeines Krankenhaus Celle
City
Celle
State/Province
Niedersachsen
ZIP/Postal Code
29223
Country
Germany
Facility Name
Städtisches Klinikum Lüneburg
City
Lüneburg
State/Province
Niedersachsen
ZIP/Postal Code
21339
Country
Germany
Facility Name
Klinikum Osnabrück GmbH
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49076
Country
Germany
Facility Name
Johanniter-Krankenhaus Rheinhausen
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47228
Country
Germany
Facility Name
Sankt Elisabeth Hospital Gütersloh
City
Gütersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Facility Name
Krankenhaus Köln-Holweide
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51067
Country
Germany
Facility Name
Klinik Evang. Krankenhaus Kalk
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51103
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Lüdenscheid
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58515
Country
Germany
Facility Name
Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
City
Bochum
State/Province
Nordrhein-Wetsfalen
ZIP/Postal Code
44892
Country
Germany
Facility Name
Krankenhaus St. Marienwörth
City
Bad Kreuznach
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55543
Country
Germany
Facility Name
Diakonissen-Stiftungs-Krankenhaus Speyer
City
Speyer
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67346
Country
Germany
Facility Name
Gastroenterologische Schwerpunktpraxis Völklingen
City
Völklingen
State/Province
Saarland
ZIP/Postal Code
66333
Country
Germany
Facility Name
Diakonissenkrankenhaus Dessau gemeinnützige GmbH
City
Dessau-Roßlau
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06846
Country
Germany
Facility Name
Evangelisches Krankenhaus Paul Gerhardt Stift
City
Lutherstadt Wittenberg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06886
Country
Germany
Facility Name
Praxis für Innere Medizin Dr. med. Regine Lange
City
Lutherstadt Wittenberg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06886
Country
Germany
Facility Name
Klinikum Magdeburg gemeinnützige GmbH
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39130
Country
Germany
Facility Name
HELIOS Klinik Sangerhausen
City
Sangerhausen
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06526
Country
Germany
Facility Name
Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04177
Country
Germany
Facility Name
Westküstenklinikum Heide
City
Heide
State/Province
Schleswig-Holstein
ZIP/Postal Code
25746
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

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

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