Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
Study NCT ID:
NCT04343950
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2020-04-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMS Messaging as a Tool to Improve Cancer Screening Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Invited individuals to the cancer screening programs will not be aware of the different arms of the study.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention 1: SMS reminders for colorectal cancer screening compared to reminder letters.\n\nIntervention 2: SMS reminders to return the fecal occult blood test at the pharmacy compared to no intervention.\n\nIntervention 3: Invitation by SMS for women with a prior participation in the breast cancer screening program compared to invitation letter.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention 1: Participation in colorectal cancer screening program', 'timeFrame': '18 weeks', 'description': 'Participation (no/yes) will be gathered prospectively 18 weeks after sending the screening invitation letter (week 0).'}, {'measure': 'Intervention 2: Participation in colorectal cancer screening program among individuals who pick the test at the pharmacy', 'timeFrame': '18 weeks', 'description': 'Participation (no/yes) among those individuals who pick the screening test for colorectal cancer at the pharmacy 18 weeks after sending the screening invitation letter (week 0).'}, {'measure': 'Intervention 3: Participation in breast cancer screening program', 'timeFrame': '8 weeks', 'description': 'Participation (no/yes) will be gathered prospectively 8 weeks after sending the screening invitation letter (week 0).'}], 'secondaryOutcomes': [{'measure': 'Incremental cost ratio', 'timeFrame': '18 weeks', 'description': 'A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uptake', 'Participation', 'Cost-effectiveness', 'Breast cancer screening', 'Colorectal cancer screening', 'Text-message', 'Mobile-health'], 'conditions': ['Mass Screening', 'Colorectal Cancer', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39742454', 'type': 'BACKGROUND', 'citation': 'Vives N, Binefa G, Travier N, Farre A, Panera JA, Casas B, Vidal C, Ibanez-Sanz G, Garcia M; M-TICS research group. Text Messaging Versus Postal Reminders to Improve Participation in a Colorectal Cancer Screening Program: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 1;13:e64243. doi: 10.2196/64243.'}, {'pmid': '39208325', 'type': 'BACKGROUND', 'citation': 'Vives N, Vidal C, de Guzman EN, Farre A, Panera JA, Binefa G, Garcia M; M-TICS research group. The use of text messages as an alternative invitation method for breast cancer screening: A randomized controlled trial (M-TICS study). PLoS One. 2024 Aug 29;19(8):e0306720. doi: 10.1371/journal.pone.0306720. eCollection 2024.'}, {'pmid': '39083331', 'type': 'BACKGROUND', 'citation': 'Vives N, Travier N, Farre A, Binefa G, Vidal C, Perez Lacasta MJ, Ibanez-Sanz G, Nino de Guzman EP, Panera JA, Garcia M; M-TICS Research Group. Effectiveness and Acceptability of Targeted Text Message Reminders in Colorectal Cancer Screening: Randomized Controlled Trial (M-TICS Study). JMIR Public Health Surveill. 2024 Jul 31;10:e57959. doi: 10.2196/57959.'}, {'pmid': '33481914', 'type': 'BACKGROUND', 'citation': 'Vives N, Farre A, Ibanez-Sanz G, Vidal C, Binefa G, Mila N, Perez-Lacasta MJ, Travier N, Benito L, Espinas JA, Bagaria G, Garcia M. Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol. PLoS One. 2021 Jan 22;16(1):e0245806. doi: 10.1371/journal.pone.0245806. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to assess the impact on health and economics of the implementation of text messaging (SMS) in cancer screening programs. Three interventions with SMS will be evaluated through community trials. In the colorectal cancer screening program the following interventions will be tested: a) Participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder SMS will be sent in front of the usual method by letter; b) Reminder to return the fecal occult blood test: SMS reminder of test delivery versus no intervention. This reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. The impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. In the breast cancer screening program, the invitation by SMS versus the usual invitation by letter will be studied in women who had participated in the previous screening round. The impact on participation will be analyzed. A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.', 'detailedDescription': 'Main Hypothesis:\n\nThe implementation of SMS in population-based cancer screening programs will improve participation, especially in colorectal cancer screening, will allow a better resource management and reduce costs in both programs.\n\nSpecific Hypothesis:\n\nSending the reminder SMS will have an impact on participation greater than that obtained with the standard reminder (letter) in the colorectal cancer screening program.\n\nThe effect of the colorectal cancer screening reminder SMS will be greater among the individuals who have been invited for the first time and not previous participants.\n\nParticipation after receiving the invitation by SMS in breast cancer screening will be equal to or better than the letter invitation.\n\nThe alternative that includes sending SMS will be cost-effective in relation to the current alternative that you use postal shipping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Intervention 1 and 2: both sexes. Intervention 3: only women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible individuals for colorectal cancer screening (intervention 1 and 2)\n* Eligible women for breast cancer screening (intervention 3)\n* Registered at the HealthCare Database (RCA)\n\nExclusion Criteria:\n\n* Individuals without a mobile phone number registered at the RCA\n* Opt out from breast cancer screening and/or colorectal cancer screening'}, 'identificationModule': {'nctId': 'NCT04343950', 'acronym': 'M-TICS', 'briefTitle': 'SMS Messaging as a Tool to Improve Cancer Screening Programs', 'organization': {'class': 'OTHER', 'fullName': "Institut Català d'Oncologia"}, 'officialTitle': 'Implementation of Text Messaging (SMS) as an Improvement Tool in Population-based Cancer Screening Programs', 'orgStudyIdInfo': {'id': 'ICO_UCC_202001'}, 'secondaryIdInfos': [{'id': 'PI19/00226', 'type': 'OTHER_GRANT', 'domain': 'The National Institute of Health Carlos III (ISCIII)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 1: SMS reminders in colorectal cancer screening', 'description': "SMS reminders will be sent to individuals who received an invitation letter from Colorectal Cancer Screening Program and haven't participated within 6 weeks.", 'interventionNames': ['Behavioral: SMS reminders to enhance colorectal cancer screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care 1: Reminder letter in colorectal cancer screening', 'description': "Reminder letters will be sent to individuals who received an invitation letter from the Colorectal Cancer Screening Program and haven't participated within 6 weeks.", 'interventionNames': ['Behavioral: SMS reminders to enhance colorectal cancer screening']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 2: SMS reminders to return the screening test', 'description': "SMS reminders will be sent to individuals who picked the fecal immunochemical test at the pharmacy and haven't returned it within 14 days.", 'interventionNames': ['Behavioral: SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care 2: No intervention', 'description': 'No reminders will be sent.', 'interventionNames': ['Behavioral: SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 3: SMS invitation among prior participants', 'description': 'Invitation by SMS will be sent to women who previously participated in the Breast Cancer Screening Program.', 'interventionNames': ['Behavioral: Invitation by SMS to previous participants in breast cancer screening:']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care 3: Invitation letter', 'description': 'Letter invitations will be sent.', 'interventionNames': ['Behavioral: Invitation by SMS to previous participants in breast cancer screening:']}], 'interventions': [{'name': 'SMS reminders to enhance colorectal cancer screening', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention 1'], 'description': 'Individual randomization will be used. Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).', 'armGroupLabels': ['Intervention 1: SMS reminders in colorectal cancer screening', 'Usual Care 1: Reminder letter in colorectal cancer screening']}, {'name': 'SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention 2'], 'description': 'Individual randomization will be used. Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).', 'armGroupLabels': ['Intervention 2: SMS reminders to return the screening test', 'Usual Care 2: No intervention']}, {'name': 'Invitation by SMS to previous participants in breast cancer screening:', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention 3'], 'description': 'Individual randomization. Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).', 'armGroupLabels': ['Intervention 3: SMS invitation among prior participants', 'Usual Care 3: Invitation letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Institut Català d'Oncologia", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Montse Garcia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Català d'Oncologia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Català d'Oncologia", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Dundee', 'class': 'OTHER'}, {'name': 'University of Barcelona', 'class': 'OTHER'}, {'name': 'University Rovira i Virgili', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}