Evaluation of evidence-based patient information on colorectal cancer screening

ISRCTN	ISRCTN47105521
DOI	https://doi.org/10.1186/ISRCTN47105521
Protocol serial number	01EL0714
Sponsor	Federal Ministry of Education and Research (BMBF) (Germany)
Funder	Federal Ministry of Education and Research (BMBF) (Germany)

Submission date: 13/06/2008
Registration date: 10/07/2008
Last edited: 10/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anke Steckelberg
Scientific

University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
20146
Germany

Email	ASteckelberg@uni-hamburg.de

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	EVA DK
Study objectives	Evidence-based patient information leads to more informed choices in colorectal cancer screening than traditional information.
Ethics approval(s)	Local Ethics Committee in Hamburg. Date of approval: 05/06/2008 (ref: PV2955)
Health condition(s) or problem(s) studied	Healthy adults
Intervention	Experimental intervention: Evidence-based patient information on colorectal cancer screening and interactive teaching modules on diagnostics and risk. The interactive teaching modules are available online, and the participants are free to decide how long and how often they use the tool to study on their own. Control intervention: Standard patient information
Intervention type	Other
Primary outcome measure(s)	Informed choice, consisting of the following three dimensions: 1. Knowledge 2. Uptake of colorectal cancer screening 3. Attitude towards colorectal cancer screening Informed choice is measured using the validated questionnaire "Measure of Informed Choice" 6 weeks after the intervention has been provided. Added as of 05/03/2009: Data analyses of knowledge, attitude and uptake questionnaires will be performed according to a predefined coding guide, which has been deposited at a staff member not involved in the study. Data entry and analyses will be carried out blinded.
Key secondary outcome measure(s)	Knowledge on colorectal cancer screening and uptake, surveyed within the primary endpoint are analysed separately as secondary endpoints. Uptake is also surveyed 6 months after the intervention has been provided. In addition, uptake is verified with data from the Statutory Health Insurance Company Gmünder Ersatzkasse (GEK) at 6 months.
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1140
Key inclusion criteria	1. Both males and females 2. Age: 50 - 75 3. No colorectal cancer 4. Insured persons of the Statutory Health Insurance Company Gmünder Ersatzkasse (GEK)
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/06/2008
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Germany

Study participating centre

University of Hamburg

Hamburg
20146
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/06/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes