Clinical trial · Interventional
Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gamified Mobile App | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- interventionNames
- Other: Gamified Mobile App
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Awareness
- timeFrame
- From enrollment to 6 months
- description
- Informed choice, using the three-dimensional model by Marteau, including: Knowledge (minimum score 7/13); Attitude (score \>24); Behavioural intention (actual participation).
Secondary outcomes (3)
- measure
- Uptake of CRC screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 51 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDHersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4. Epub 2015 Feb 18. PMID 25701273
- BACKGROUNDWallston KA, Wallston BS, DeVellis R. Development of the Multidimensional Health Locus of Control (MHLC) Scales. Health Educ Monogr. 1978 Spring;6(2):160-70. doi: 10.1177/109019817800600107. PMID 689890
- BACKGROUNDDuan Y, Shang B, Liang W, Du G, Yang M, Rhodes RE. Effects of eHealth-Based Multiple Health Behavior Change Interventions on Physical Activity, Healthy Diet, and Weight in People With Noncommunicable Diseases: Systematic Review and Meta-analysis. J Med Internet Res. 2021 Feb 22;23(2):e23786. doi: 10.2196/23786. PMID 33616534
- BACKGROUNDSequi-Dominguez I, Alvarez-Bueno C, Martinez-Vizcaino V, Fernandez-Rodriguez R, Del Saz Lara A, Cavero-Redondo I. Effectiveness of Mobile Health Interventions Promoting Physical Activity and Lifestyle Interventions to Reduce Cardiovascular Risk Among Individuals With Metabolic Syndrome: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Aug 31;22(8):e17790. doi: 10.2196/17790. PMID 32865503
- BACKGROUNDMohamad Marzuki MF, Yaacob NA, Bin Yaacob NM, Abu Hassan MR, Ahmad SB. Usable Mobile App for Community Education on Colorectal Cancer: Development Process and Usability Study. JMIR Hum Factors. 2019 Apr 16;6(2):e12103. doi: 10.2196/12103. PMID 30990454
- BACKGROUNDHammedi, W., Leclerq, T. & Van Riel, A. C. R. The use of gamification mechanics to increase employee and user engagement in participative healthcare services: A study of two cases. J. Serv. Manag. 28, 640-661 (2017).
- BACKGROUNDRotter, J. B. (1954). Social learning and clinical psychology. Prentice-Hall, Inc