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Open Access 01-12-2018 | Study protocol

The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial

Authors: Pernille Gabel, Mette Bach Larsen, Pia Kirkegaard, Adrian Edwards, Berit Andersen

Published in: Trials | Issue 1/2018

Abstract

Background

Colorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact with healthcare professionals. Citizens with lower educational attainment tend to participate less in colorectal cancer screening than citizens with average educational attainment. Further, they tend to have lower levels of knowledge about colorectal cancer screening. Providing lower educational attainment citizens with a targeted decision aid embracing their diverse information needs might increase these citizens’ ability to make informed decisions. The aim of this trial is to test the effectiveness of such a newly developed self-administered decision aid.

Methods

The LEAD (Lower Educational Attainment Decision aid) trial will be conducted as a two-arm randomized controlled trial among 10,000 50–74-year-old citizens, resident in the Central Denmark Region not yet invited to take up colorectal cancer screening. Citizens will receive a baseline questionnaire. Respondents will be allocated into the intervention or the control groups. Citizens in the intervention group will receive the decision aid whereas the control group will not. Those who return a stool sample within 45 days after receiving the screening invitation and those with medium or higher educational attainment are excluded. Both groups will receive a follow-up questionnaire 90 days after being invited to colorectal cancer screening.

A historic cohort consisting of 5000 50–74-year-old citizens resident in the Central Denmark Region, having received their screening invitation in the beginning of 2017 will be included. This cohort will receive a follow-up questionnaire 6–9 months after they received the screening invitation.

Informed choice will be evaluated by assessing levels of knowledge, attitudes, and screening uptake. Analyses will be conducted as intention-to-treat analyses. Additionally, differences between levels of worry and decisional conflict between groups will be assessed as secondary outcomes.

Discussion

This trial will evaluate whether a targeted decision aid is a feasible way of enhancing informed choice among lower educational attainment citizens in colorectal cancer screening. Further, it may guide decisions about providing information material in cancer screening in general.

Trial registration

ClinicalTrials.gov, NCT03253888. Registered on 17 August 2017.

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Title: The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial
Authors: Pernille Gabel
Mette Bach Larsen
Pia Kirkegaard
Adrian Edwards
Berit Andersen
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2921-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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