Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-14 @ 2:15 AM
Study NCT ID:
NCT07269028
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-28', 'size': 788949, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-10-24T08:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awareness', 'timeFrame': 'From enrollment to 6 months', 'description': 'Informed choice, using the three-dimensional model by Marteau, including:\n\nKnowledge (minimum score 7/13); Attitude (score \\>24); Behavioural intention (actual participation).'}], 'secondaryOutcomes': [{'measure': 'Uptake of CRC screening', 'timeFrame': 'From enrollment to 31st December 2024', 'description': 'ATS Brescia provided pseudonymised data on actual FOBT participation.'}, {'measure': 'Knowledge of primary prevention and healthy behaviours,', 'timeFrame': 'From enrollment to 6 months', 'description': 'Assessment through 13 multiple-choice questions. Participants were classified based on correct responses as:\n\nLow knowledge (0-5 correct answers); Moderate knowledge (6-8); High knowledge (9-13);'}, {'measure': 'Decisional conflict, user satisfaction, and app acceptability', 'timeFrame': 'From enrollment to 6 months', 'description': 'Evaluation through items related to the decision-making process and perceived usefulness of the decision aid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colo-rectal cancer', 'Prevention', 'eHealth', 'Gamification'], 'conditions': ['Colo-rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25701273', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '689890', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33616534', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32865503', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30990454', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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).'}, {'type': 'BACKGROUND', 'citation': 'Rotter, J. B. (1954). Social learning and clinical psychology. Prentice-Hall, Inc'}, {'pmid': '32546834', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33170877', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28402085', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19922647', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14512487', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nDA-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.\n\nUpon 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable residence within one of the municipalities served by Brescia LHA;\n* Ownership of a smartphone (Android or iOS);\n* Proficiency in the Italian language;\n* Provision of informed consent within the PREVenGO app.\n\nExclusion Criteria:\n\n* Failure to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07269028', 'acronym': 'DA-CRC', 'briefTitle': 'Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening', 'orgStudyIdInfo': {'id': 'Protocol Number: NP5686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: Gamified Mobile App']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Gamified Mobile App', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Agenzia per la Tutela della Salute (ATS) di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Cristina Montomoli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agenzia di Tutela della Salute (ATS) di Brescia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Cristina Montomoli', 'investigatorAffiliation': 'University of Pavia'}}}}