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

NCT07269028 | Completed

• 1 other identifier: Protocol Number: NP5686
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Colo-rectal Cancer

Keywords

Colo-rectal cancer; Prevention; eHealth; Gamification

Outcome Measures

Primary Outcomes (1)

• Awareness

  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 Outcomes (3)

• Uptake of CRC screening

  From enrollment to 31st December 2024

• Knowledge of primary prevention and healthy behaviours,

  From enrollment to 6 months

• Decisional conflict, user satisfaction, and app acceptability

  From enrollment to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Gamified Mobile App

Control

NO INTERVENTION

Interventions

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.

Intervention

Eligibility Criteria

• Age: 50 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Failure to provide informed consent.

Sponsors & Collaborators

• University of Pavia: lead
• Agenzia di Tutela della Salute (ATS) di Brescia: collaborator

Study Sites (1)

Agenzia per la Tutela della Salute (ATS) di Brescia

Brescia, Brescia, 25123, Italy

Location

Related Publications (13)

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  PMID: 32865503 BACKGROUND

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  PMID: 30990454 BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Roberto A, Colombo C, Candiani G, Satolli R, Giordano L, Jaramillo L, Castagno R, Mantellini P, Falini P, Carnesciali E, Valenza M, Costa L, Campari C, Caroli S, Faggiano RC, Orione L, Belmessieri B, Marchio V, Deandrea S, Silvestri A, Luciano D, Paci E, Mosconi P. A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy. Br J Cancer. 2020 Sep;123(5):714-721. doi: 10.1038/s41416-020-0935-2. Epub 2020 Jun 17.

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  PMID: 28402085 BACKGROUND

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  PMID: 19922647 BACKGROUND

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  PMID: 14512487 BACKGROUND

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  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Cristina Montomoli

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

IT (1)