Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening (DA-CRC)

November 25, 2025 updated by: Cristina Montomoli, University of Pavia

Colorectal cancer (CRC) is the second leading cause of cancer-related mortality worldwide, accounting for approximately 903,000 deaths annually. While population-based screening programmes have demonstrated effectiveness in enhancing early detection and reducing mortality, participation rates remain suboptimal. Adherence is influenced by cognitive, psychological, and socioeconomic barriers.

This study aimed to assess the impact of a digital decision aid (DA), incorporating personalisation and gamification elements, on informed decision-making and adherence to CRC screening.

DA-CRC is a two-arm randomised controlled pilot trial. Individuals born in 1973-1974 living in the area served by the local health authority of Brescia (Northern Italy) who were invited for the first time to participate in the CRC screening programme, were eligible. An invitation letter, including instructions to download the PREVenGO app, was mailed to potential participants.

Upon download, participants were randomised to either the intervention or control arm. The intervention app included questionnaires on family history, knowledge of primary and secondary prevention, and locus of control (LoC), as well as gamification and reward features. The control app provided static educational content only. Notifications prompted users to complete follow-up assessments at 3 months (T1) and 6 months (T2), receive prevention information, and attend screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Brescia
      • Brescia, Brescia, Italy, 25123
        • Agenzia per la Tutela della Salute (ATS) di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Stable residence within one of the municipalities served by Brescia LHA;
  • Ownership of a smartphone (Android or iOS);
  • Proficiency in the Italian language;
  • Provision of informed consent within the PREVenGO app.

Exclusion Criteria:

  • Failure to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Gamified Mobile App
The intervention app included questionnaires on family history, knowledge of primary and secondary prevention, and locus of control (LoC), as well as gamification and reward features.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awareness
Time Frame: From enrollment to 6 months

Informed choice, using the three-dimensional model by Marteau, including:

Knowledge (minimum score 7/13); Attitude (score >24); Behavioural intention (actual participation).
From enrollment to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of CRC screening
Time Frame: From enrollment to 31st December 2024
ATS Brescia provided pseudonymised data on actual FOBT participation.
From enrollment to 31st December 2024
Knowledge of primary prevention and healthy behaviours,
Time Frame: From enrollment to 6 months

Assessment through 13 multiple-choice questions. Participants were classified based on correct responses as:

Low knowledge (0-5 correct answers); Moderate knowledge (6-8); High knowledge (9-13);
From enrollment to 6 months
Decisional conflict, user satisfaction, and app acceptability
Time Frame: From enrollment to 6 months
Evaluation through items related to the decision-making process and perceived usefulness of the decision aid
From enrollment to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

Agenzia di Tutela della Salute (ATS) di Brescia

Investigators

  • Principal Investigator: Cristina Montomoli, University of Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol Number: NP5686

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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