Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia

Colorectal Cancer Clinical Trial

Official title:

Using Behavioural and Cultural Insights to Understand and Address Barriers and Drivers to Colorectal Cancer Home-testing in Croatia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341322
• Other study ID #: ERC0003996
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: World Health Organization
• Contact: Veerle Snijders
• Phone: +31642641587
• Email: snijdersv[@]who.int
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• eligible to participate in the national colorectal cancer screening programme

• live in a study location (Split-Dalmatia or Zagreb City counties)

• did not respond to the cancer screening invite letter

Exclusion Criteria:

• participated in the colorectal screening programme in the last 24 months

Related Conditions & MeSH terms

• Behavior Change
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Standard letter
A reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter.
• Behaviorally informed 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.
• Home testing colorectal cancer kit
The home testing kit is included with the reminder letter, instead of the usual process of responding to the letter to order the kit

Locations

Country	Name	City	State
Croatia	Croatian Institute of Public Health	Zagreb

Sponsors (3)

Lead Sponsor	Collaborator
Veerle Snijders	Andrija Štampar School of Public Health, Croatian Institute of Public Health

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home test kit ordered	Did the participant order the colorectal cancer home testing kit? Routinely collected data.	5 weeks
Primary	Completed colorectal cancer screening	Did the participant complete the home testing kit and return it to the health authority? Routinely collected data.	5 weeks
Secondary	Opted out	Did the participant actively opt out of participating in the screening program? Routinely collected data.	5 weeks
Secondary	Qualitative feedback	Qualitative feedback on the intervention arms and colorectal cancer screening experience. Collected through 24 semi-structured interviews.	10 weeks