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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07269028
Acronym
DA-CRC
Enrollment
248
Registered
2025-12-08
Start date
2023-05-15
Completion date
2024-12-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer

Keywords

Colo-rectal cancer, Prevention, eHealth, Gamification

Brief summary

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.

Interventions

OTHERGamified 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.

Sponsors

Agenzia di Tutela della Salute (ATS) di Brescia
CollaboratorUNKNOWN
University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Randomized Clinical Trial

Eligibility

Sex/Gender
ALL
Age
50 Years to 51 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
AwarenessFrom enrollment to 6 monthsInformed choice, using the three-dimensional model by Marteau, including: Knowledge (minimum score 7/13); Attitude (score \>24); Behavioural intention (actual participation).

Secondary

MeasureTime frameDescription
Uptake of CRC screeningFrom enrollment to 31st December 2024ATS Brescia provided pseudonymised data on actual FOBT participation.
Knowledge of primary prevention and healthy behaviours,From enrollment to 6 monthsAssessment 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);
Decisional conflict, user satisfaction, and app acceptabilityFrom enrollment to 6 monthsEvaluation through items related to the decision-making process and perceived usefulness of the decision aid

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 1, 2026