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

University of Pavia

Status: Completed

Conditions: Colo-rectal Cancer

Treatments: Other: Gamified Mobile App

Study type: Interventional

Funder types: Other

Identifiers

NCT07269028

Protocol Number: NP5686

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 50 to 51 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

248 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Gamified Mobile App

Control

No Intervention group