An interventional study of Standard letter and Behaviorally informed letter in Colorectal Cancer and Behavior Change, sponsored by Veerle Snijders. Recruiting at 1 site in Croatia. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Veerle Snijders · Not applicable, Interventional, and Screening
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:
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 13,000 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Veerle Snijders as lead sponsor.
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Exclusion Criteria:
Participants do not receive a reminder letter, which is treatment as usual.
Participants receive a reminder letter which is based on the current colorectal cancer screening invitation.
Behavioral: Standard letter
Participants receive a reminder letter which incorporates several behavioral components, including an active choice prompt, social norm, simplification, chunking and call to action.
Behavioral: Behaviorally informed letter
Participants receive the behaviorally informed letter plus the colorectal home testing kit, which removes the current barrier of having to request a kit.
Behavioral: Behaviorally informed letter · Behavioral: Home testing colorectal cancer kit
A reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter.
A reminder letter to encourage recipients to order the colorectal cancer home testing kit, with incorporates severally behaviorally informed components, including an active choice prompt, social norm, call to action, chunking and simplification.
The home testing kit is included with the reminder letter, instead of the usual process of responding to the letter to order the kit
Home test kit ordered
Did the participant order the colorectal cancer home testing kit? Routinely collected data.
Time frame: 5 weeks
Completed colorectal cancer screening
Did the participant complete the home testing kit and return it to the health authority? Routinely collected data.
Time frame: 5 weeks
Opted out
Did the participant actively opt out of participating in the screening program? Routinely collected data.
Time frame: 5 weeks
Qualitative feedback
Qualitative feedback on the intervention arms and colorectal cancer screening experience. Collected through 24 semi-structured interviews.
Time frame: 10 weeks
Plan to share: No — The study utilizes the data that is routinely collected as part the Croatian National Screening Database, only specific approved members of the screening program are able to access and utilize this data. For this reason, it is currently not planned to share individual participant data.
No publications or documents are linked to this record.
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