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| Name | Class |
|---|---|
| Agenzia di Tutela della Salute (ATS) di Brescia | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of CRC screening | ATS Brescia provided pseudonymised data on actual FOBT participation. | From enrollment to 31st December 2024 |
| Knowledge of primary prevention and healthy behaviours, | 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); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Montomoli | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agenzia per la Tutela della Salute (ATS) di Brescia | Brescia | Brescia | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25701273 | Background | Hersch 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. | |
| 689890 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 28, 2024 | Oct 24, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Randomized Clinical Trial
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| From enrollment to 6 months |
| Decisional conflict, user satisfaction, and app acceptability | Evaluation through items related to the decision-making process and perceived usefulness of the decision aid | From enrollment to 6 months |
| Wallston 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. |
| 33616534 | Background | Duan 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. |
| 32865503 | Background | Sequi-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. |
| 30990454 | Background | Mohamad 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. |
| Background | Hammedi, 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). |
| Background | Rotter, J. B. (1954). Social learning and clinical psychology. Prentice-Hall, Inc |
| 32546834 | 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. |
| 33170877 | Background | Gabel P, Larsen MB, Edwards A, Kirkegaard P, Andersen B. Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. PLoS One. 2020 Nov 10;15(11):e0241703. doi: 10.1371/journal.pone.0241703. eCollection 2020. |
| 28402085 | Background | Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. |
| 19922647 | Background | Elwyn G, Frosch D, Rollnick S. Dual equipoise shared decision making: definitions for decision and behaviour support interventions. Implement Sci. 2009 Nov 18;4:75. doi: 10.1186/1748-5908-4-75. |
| 14512487 | Background | O'Connor AM, Legare F, Stacey D. Risk communication in practice: the contribution of decision aids. BMJ. 2003 Sep 27;327(7417):736-40. doi: 10.1136/bmj.327.7417.736. |
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. |
| 42216438 | Derived | Celebrin M, Filosa A, Anelli M, Brucchi F, La Torraca Vittori P, Incremona A, Rogledi M, Summer A, Vizzardi M, Ghidini P, Bregoli M, Hoxha E, Marazza G, Gorini A, Montomoli C. A Personalised and Gamified Digital Decision Aid for Colorectal Cancer Screening: A Randomised Controlled Pilot Study. Cancer Med. 2026 Jun;15(6):e71991. doi: 10.1002/cam4.71991. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |