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

NCT03253822 | Completed

• 1 other identifier: 2012-58-006--1-16-02-94-16
• Study Type: interventional
• Target: 15,030
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colorectal Neoplasms; Decision Support Techniques; Early Detection of Cancer; Educational Status; Decision Making; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (3)

• CRC and CRC screening knowledge

  Assessed using questionnaire. Six items yielding a scale score between 0 and 100 %. Continous variable.

  Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3)

• CRC screening attitude

  Assessed using questionnaire. Four items. Scores between 7 and 28. Continuous variable.

  Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3)

• CRC screening participation

  Binary outcome (yes/no), retrieved from screening IT system.

  Obtained at least three months after screening invitation.

Secondary Outcomes (8)

• CRC worry

  Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3)

• Decisional conflict

  Assessed at least three months after invitation (study arm 1+2+3)

• Health literacy

  Assessed before screening invitation (study arm 1+2) or at least three months after screening invitation (study arm 3)

• Educational level

  Up to 12 months before screening invitation

• Family income

  Up to 12 months before screening invitation

Study Arms (3)

Intervention group

EXPERIMENTAL

This group receives a baseline questionnaire before their screening invitation. Respondents are included, and those receiving a screening reminder receive the decision aid. At least three months after their screening invitation the included citizens (baseline questionnaire respondents) will receive a follow-up questionnaire.

Other: Decision aid

Control group

NO INTERVENTION

This group receives a baseline questionnaire before their screening invitation. Respondents are included. At least three months after their screening invitation, baseline questionnaire respondents will receive a follow-up questionnaire.

Historic cohort

NO INTERVENTION

A group of people already invited for colorectal cancer screening. This group receives a questionnaire at least three months after their screening invitation. Respondents are included in the study.

Interventions

Decision aid OTHER

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.

Also known as: DA

Intervention group

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Random sample of citizens 50-74 years of age.
• Resident in the Central Denmark Region at time of data extraction (August 2017)
• Month of birth: December or October

You may not qualify if:

• Non-respondents to baseline questionnaire (study arm 1+2) or questionnaire (study arm 3)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Public Health Programmes, Randers Regional Hospital

Randers, DK-8930, Denmark

Location

MeSH Terms

Conditions

Behavior; Colorectal Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Pernille Gabel, MD PhD Fel.

  Department of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since baseline questionnaire is filled out before randomizasion, and citizens will know if they receive the DA or not, participants will not be masked. No care providers are involved in the screening program in the phases we study (invitation, reminder, and stool sample), hence no masking in this groups. The outcomes are assessed via questionnaire data or from registries (Statistics Denmark and the screening IT system), and no masking is necessary in neither investigators nor outcomes assessors.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD Fellow

Model Details: The LEAD trial is conducted as a two arm, randomised controlled trial nested into a population-based, organized CRC screening programme conducted in the Central Denmark Region. Citizens who are scheduled to be invited for CRC screening within the study period will be randomly allocated into one two study arms. Further, a historic study arm will be included, in order to be able to assess the effect of receiving the baseline questionnaire: 1. To receive the DA along with the screening reminder and to receive both baseline and follow-up questionnaires (intervention group) 2. To receive both baseline and follow-up questionnaires (control group) 3. To receive a questionnaire comprisng scales from both baseline and follow-up questionnaires (historic cohort) Regardless of study arm, all citizens receive standard CRC screening information material according to the CRC screening program procedures.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: August 18, 2017
• Study Start: August 15, 2017
• Primary Completion: April 3, 2018
• Study Completion: April 23, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)