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OpenTrials
Completed

NCT Number: NCT07269028

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

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.

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Key information

Age range

50 year–51 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agenzia per la Tutela della Salute (ATS) di Brescia

Brescia, 25123, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gamified Mobile App

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Uptake of CRC screening

    Time frame: From enrollment to 31st December 2024

    ATS Brescia provided pseudonymised data on actual FOBT participation.

  2. 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);

  3. 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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Collaborators

  • Agenzia di Tutela della Salute (ATS) di Brescia

Registry information

Acronym: DA-CRC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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