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Trial Title:
Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia
NCT ID:
NCT06341322
Condition:
Colorectal Cancer
Behavior Change
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
cancer screening
behavioral insights
communications
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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).
Primary purpose:
Screening
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Standard letter
Description:
A reminder letter to encourage recipients to order the colorectal cancer home testing
kit, based on the current invite letter.
Arm group label:
Standard letter
Intervention type:
Behavioral
Intervention name:
Behaviorally informed letter
Description:
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.
Arm group label:
Behaviorally informed letter
Arm group label:
Behaviorally informed letter + testing kit
Intervention type:
Behavioral
Intervention name:
Home testing colorectal cancer kit
Description:
The home testing kit is included with the reminder letter, instead of the usual process
of responding to the letter to order the kit
Arm group label:
Behaviorally informed letter + testing kit
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Croatian Institute of Public Health
Address:
City:
Zagreb
Country:
Croatia
Status:
Recruiting
Contact:
Last name:
Ivana Brkić Biloš, MD
Email:
ivana.brkic@hzjz.hr
Contact backup:
Last name:
Nataša Antoljak, Prof
Email:
natasa.antoljak@hzjz.hr
Start date:
March 5, 2024
Completion date:
July 2024
Lead sponsor:
Agency:
Veerle Snijders
Agency class:
Other
Collaborator:
Agency:
Croatian Institute of Public Health
Agency class:
Other
Collaborator:
Agency:
Andrija Štampar School of Public Health
Agency class:
Other
Source:
World Health Organization
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341322
