Colorectal CancerNCT06341322
Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia
A study testing Standard letter, Behaviorally informed letter and Home testing colorectal cancer kit in people with Colorectal Cancer and Behavior Change, run by Veerle Snijders at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Behavior Change
- What is being tested?
- Standard letter, Behaviorally informed letter and Home testing colorectal cancer kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,000 participants
- Where
- 1 siteCroatia
- Study dates
- 5 Mar 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participated in the colorectal screening programme in the last 24 months
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Croatian Institute of Public Health
Zagreb
Ivana Brkić Biloš, MD, ivana.brkic@hzjz.hr
Nataša Antoljak, Prof, natasa.antoljak@hzjz.hr
About this study
Official title: Using Behavioural and Cultural Insights to Understand and Address Barriers and Drivers to Colorectal Cancer Home-testing in Croatia
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:
Read more
- 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.
- 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.
- Conditions
- Colorectal Cancer, Behavior Change
- Being tested
- Standard letter, Behaviorally informed letter, Home testing colorectal cancer kit
- Keywords
- colorectal cancer, cancer screening, behavioral insights, communications
- Medical subject headings
- Colorectal Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard letterBehavioural
A reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter.
Behaviorally informed letterBehavioural
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 kitBehavioural
The home testing kit is included with the reminder letter, instead of the usual process of responding to the letter to order the kit
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants do not receive a reminder letter, which is treatment as usual. |
| Standard letter | Experimental | Participants receive a reminder letter which is based on the current colorectal cancer screening invitation. Receives: Behavioral: Standard letter |
| Behaviorally informed letter | Experimental | Participants receive a reminder letter which incorporates several behavioral components, including an active choice prompt, social norm, simplification, chunking and call to action. Receives: Behavioral: Behaviorally informed letter |
| Behaviorally informed letter + testing kit | Experimental | Participants receive the behaviorally informed letter plus the colorectal home testing kit, which removes the current barrier of having to request a kit. Receives: Behavioral: Behaviorally informed letter; Behavioral: Home testing colorectal cancer kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home test kit ordered
Did the participant order the colorectal cancer home testing kit? Routinely collected data.
Measured: 5 weeks
Completed colorectal cancer screening
Did the participant complete the home testing kit and return it to the health authority? Routinely collected data.
Measured: 5 weeks
Secondary outcomes (2)
Opted out
Did the participant actively opt out of participating in the screening program? Routinely collected data.
Measured: 5 weeks
Qualitative feedback
Qualitative feedback on the intervention arms and colorectal cancer screening experience. Collected through 24 semi-structured interviews.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start5 Mar 2024
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veerle Snijders
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Institute of Public Health, Andrija Štampar School of Public Health
- Responsible party
- Sponsor-investigator, Veerle Snijders, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341322
- Sponsor's protocol ID
- ERC0003996
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioural and Cultural Insights to Understand and Address Barriers and Drivers to Colorectal Cancer Home-testing in Croatia
- ClinicalTrials.gov ID
- NCT06341322
- Acronym / sponsor ID
- ERC0003996
- Conditions
- Colorectal Cancer, Behavior Change
- Keywords
- colorectal cancer, cancer screening, behavioral insights, communications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- Veerle SnijdersUniversity, hospital or other
- Collaborators
- Croatian Institute of Public Health, Andrija Štampar School of Public Health
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants do not receive a reminder letter, which is treatment as usual. |
| Standard letter | Experimental | Behavioral: Standard letterParticipants receive a reminder letter which is based on the current colorectal cancer screening invitation. |
| Behaviorally informed letter | Experimental | Behavioral: Behaviorally informed letterParticipants receive a reminder letter which incorporates several behavioral components, including an active choice prompt, social norm, simplification, chunking and call to action. |
| Behaviorally informed letter + testing kit | Experimental | Behavioral: Behaviorally informed letter, Behavioral: Home testing colorectal cancer kitParticipants receive the behaviorally informed letter plus the colorectal home testing kit, which removes the current barrier of having to request a kit. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- participated in the colorectal screening programme in the last 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard letterA reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter. | Behavioural | Standard letter |
| Behaviorally informed letterA 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. | Behavioural | Behaviorally informed letter, Behaviorally informed letter + testing kit |
| Home testing colorectal cancer kitThe home testing kit is included with the reminder letter, instead of the usual process of responding to the letter to order the kit | Behavioural | Behaviorally informed letter + testing kit |
Primary outcome
Home test kit ordered
Time frame: 5 weeks
Did the participant order the colorectal cancer home testing kit? Routinely collected data.
Completed colorectal cancer screening
Time frame: 5 weeks
Did the participant complete the home testing kit and return it to the health authority? Routinely collected data.
2 secondary outcomes
Opted out
Time frame: 5 weeks
Qualitative feedback
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard letter, Behaviorally informed letter and Home testing colorectal cancer kit in people with Colorectal Cancer and Behavior Change, run by Veerle Snijders at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Snijders (+31642641587, snijdersv@who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home test kit ordered (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.