NCT06341322

Brief 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. 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.
  2. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

27 days

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

colorectal cancercancer screeningbehavioral insightscommunications

Outcome Measures

Primary Outcomes (2)

  • Home test kit ordered

    Did the participant order the colorectal cancer home testing kit? Routinely collected data.

    5 weeks

  • 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 Outcomes (2)

  • Opted out

    5 weeks

  • Qualitative feedback

    10 weeks

Study Arms (4)

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.

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.

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.

Behavioral: Behaviorally informed letterBehavioral: Home testing colorectal cancer kit

Interventions

Standard letterBEHAVIORAL

A reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter.

Standard 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.

Behaviorally informed letterBehaviorally informed letter + testing 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

Behaviorally informed letter + testing kit

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croatian Institute of Public Health

Zagreb, Croatia

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Central Study Contacts

Veerle Snijders

CONTACT

Tiina Likki

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Behavioural Scientist

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

March 5, 2024

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.

Locations