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Colo-rectal CancerDA-CRCNCT07269028

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

A study testing Gamified Mobile App in people with Colo-rectal Cancer, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 51 yearsHealthy volunteers can take part
Conditions the study is for
Colo-rectal Cancer
What is being tested?
Gamified Mobile App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteItaly
Study dates
15 May 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 51 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Failure to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Agenzia per la Tutela della Salute (ATS) di Brescia

    Brescia, Brescia, 25123

Other trials in Italy

About this study

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.

Read more

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.

Being tested
Gamified Mobile App
Keywords
Colo-rectal cancer, Prevention, eHealth, Gamification
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamified Mobile AppOther

    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.

Study groups in NCT07269028
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Other: Gamified Mobile App
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Awareness

    Informed choice, using the three-dimensional model by Marteau, including:

    Knowledge (minimum score 7/13); Attitude (score >24); Behavioural intention (actual participation).

    Measured: From enrollment to 6 months

Secondary outcomes (3)

  1. Uptake of CRC screening

    ATS Brescia provided pseudonymised data on actual FOBT participation.

    Measured: From enrollment to 31st December 2024

  2. 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);

    Measured: From enrollment to 6 months

  3. Decisional conflict, user satisfaction, and app acceptability

    Evaluation through items related to the decision-making process and perceived usefulness of the decision aid

    Measured: From enrollment to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start15 May 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269028
Sponsor's protocol ID
Protocol Number: NP5686
Acronym
DA-CRC
Status last verified
Nov 2025
First submitted
25 Nov 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25701273

  • 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.

    PubMed 689890

  • 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.

    PubMed 33616534

  • 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.

    PubMed 32865503

  • 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.

    PubMed 30990454

  • 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).

  • Rotter, J. B. (1954). Social learning and clinical psychology. Prentice-Hall, Inc

  • 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.

    PubMed 32546834

  • 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.

    PubMed 33170877

  • 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.

    PubMed 28402085

  • 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.

    PubMed 19922647

  • 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.

    PubMed 14512487

  • 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.

    PubMed 33538338

  • 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.

    PubMed 42216438

Questions about this trial

What is this clinical trial studying?

A study testing Gamified Mobile App in people with Colo-rectal Cancer, run by University of Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Awareness (time frame: From enrollment to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07269028, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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DA-CRC Clinical Trial NCT07269028 | AzTrials