Dataset Information

Optimising Colorectal Cancer Screening Participation

ABSTRACT: The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail. The main out-come will be participation within 6 months after invitation.

DISEASE(S): Colorectal Neoplasms

PROVIDER: 2331858 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Name of intervention: gender specific mail-administered screening invitation strategies. All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening. The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline. Baseline: Advance notification letter sent Week two: Invitation package sent Week eight: Reminder letters sent to those who have not completed an FOBT Week 14: Data collection ceases. Arm 1: Control The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP). The standard offer includes an advance notification letter and a screening invitation package. The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening. The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a particip Primary outcome(s): Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.[At 14 weeks from baseline, 12 weeks after receiving the FOBT.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy

Project description: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.

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Optimising Colorectal Cancer Screening Participation

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