protocolSection identificationModule nctId: NCT06341322, orgStudyIdInfo id: ERC0003996, briefTitle: Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Veerle Snijders, class: OTHER, collaborators name: Croatian Institute of Public Health, collaborators name: Andrija Štampar School of Public Health, descriptionModule briefSummary: Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates.   The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework., conditionsModule conditions: Colorectal Cancer, conditions: Behavior Change, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to either control (no reminder screening invitation) or one of three treatments (standard reminder letter, behaviorally informed reminder letter, behaviorally informed letter with home testing kit included)., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 13000, type: ESTIMATED, armsInterventionsModule interventions name: Standard letter, interventions name: Behaviorally informed letter, interventions name: Home testing colorectal cancer kit, outcomesModule primaryOutcomes measure: Home test kit ordered, primaryOutcomes measure: Completed colorectal cancer screening, secondaryOutcomes measure: Opted out, secondaryOutcomes measure: Qualitative feedback, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Croatian Institute of Public Health, status: RECRUITING, city: Zagreb, country: Croatia, contacts name: Ivana Brkić Biloš, MD, role: CONTACT, email: ivana.brkic@hzjz.hr, contacts name: Nataša Antoljak, Prof, role: CONTACT, email: natasa.antoljak@hzjz.hr, geoPoint lat: 45.81444, lon: 15.97798, hasResults: False