The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens

Summary

The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice (evaluated based on knowledge, attitudes and actual participation).

The study includes three study arms. Citizens to be recruited are identified from the Danish Civil Registration System based on residence (Central Denmark Region), age (50-74 years old), and month of birth. A random sample of 15,000 citizens born in December (invited for CRC screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in October (invited for CRC screening in January/February 2017) (study arm 3) is identified.

Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge, attitudes, worry, and health literacy. Non respondents will receive one reminder after two weeks and after four weeks non-respondents will receive a phone call, offering them to fill out the questionnaire via the phone. Baseline questionnaire respondents are included in the study, and will be randomized into two study arms (intervention group and control group).

Citizens in the intervention group will be identified in the screening IT system. Date of screening invitation and screening reminder (citizens who do not return a stool sample within 45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens have six weeks to respond to the questionnaire.

Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same time as the baseline questionnaires are sent out to the intervention and control groups. The citizens are included if they respond to the questionnaire within six weeks. Questionnaire reminders are sent out at two and four weeks.

Data on screening invitation date, screening reminder date, returning a stool sample and result will be retrieved from the screening IT system for all included citizens (Study arm 1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors) will be included.

Conditions

• Decision Making
• Knowledge, Attitudes, Practice

Interventions

OTHER

Decision aid

The DA is an online tool. The web-based design opens up possibilities to feature more advanced functions, e.g. questions for the participant during the process, and a summary of answers at the end. The DA is tailored to lower educational attainment citizens, and is designed to embrace different information needs in the target population, ranging from a desire to receive a clear recommendation and a minimum of information to the desire to receive full information and make a personalized choice.

Sponsors & Collaborators

• University of Aarhus

  lead OTHER

Principal Investigators

• Pernille Gabel, MD PhD Fel. · Department of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-15

Primary Completion

2018-04-03

Completion

2018-04-23

Countries

• Denmark

Study Locations