Condition category
Cancer
Date applied
13/06/2008
Date assigned
10/07/2008
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anke Steckelberg

ORCID ID

Contact details

University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
20146
Germany
ASteckelberg@uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01EL0714

Study information

Scientific title

Acronym

EVA DK

Study hypothesis

Evidence-based patient information leads to more informed choices in colorectal cancer screening than traditional information.

Ethics approval

Local Ethics Committee in Hamburg. Date of approval: 05/06/2008 (ref: PV2955)

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Patient information can be found at: http://www.chemie.uni-hamburg.de/igtw/Gesundheit/images/pdf/Probandeninformation_2008.pdf (in German)

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/06/2008

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,140

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/06/2008

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Germany

Trial participating centre

University of Hamburg
Hamburg
20146
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

Hannoversche Strasse 28-30
Berlin
10115
Germany
ASteckelberg@uni-hamburg.de

Sponsor type

Government

Website

http://www.bmbf.de/en/

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (BMBF) (Germany)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21636633

Publication citations

  1. Results

    Steckelberg A, Hülfenhaus C, Haastert B, Mühlhauser I, Effect of evidence based risk information on "informed choice" in colorectal cancer screening: randomised controlled trial., BMJ, 2011, 342, d3193.

Additional files

Editorial Notes