Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT06972160
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Project to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1038}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to colon and rectal screening [Time Frame: 6 weeks]', 'timeFrame': 'From April 2025 to June 2025 (6 weeks)', 'description': 'Increase in adherence to colon and rectal screening\n\nProportion/cumulative proportion of patients who performed colon and rectal cancer screening among those who were invited to undergo it, after step 1 (SMS1), step 2 (SMS2), step 3 (administrative call) and step 4 (medical doctor call)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon and Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'An experimental study through a randomized clinical trial, without blinding (for participants and the research team), with a control group (not subject to intervention) and an intervention group (subject to two text messages, an automated non-human call or a call made by the administrative assistant, and a phone call made by a physician).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '49 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants must be registered in the ULS of\n\nBarcelos/Esposende and meet the following criteria:\n\n1. Age between 50 and 74 years.\n2. No symptoms such as weight loss in the last 6 months or gastrointestinal symptoms.\n3. No prior diagnosis of CRC.\n4. No diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n5. No family history of CRC in first- and second-degree relatives diagnosed before age 60.\n6. No prior fecal occult blood test (FOBT) in the 11 months before receiving the collection kit or no prior sigmoidoscopy or colonoscopy in the last 24 months.\n\nExclusion Criteria:\n\n1. Participants who did not receive the screening kit at home.\n2. Participants without a phone number.\n3. Participants who do not answer the phone or refuse to participate in the study.\n4. Participants unable to consent or perform the screening due to physical, mental, or other conditions that seriously impair comprehension."}, 'identificationModule': {'nctId': 'NCT06972160', 'briefTitle': 'Intervention Project to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Local Health Unit Barcelos/Esposende, Public Health Unit'}, 'officialTitle': 'Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Rede+Rastreio-Cancro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Group', 'description': 'The interventional group will be subjected to interventions to increase the adherence to screening, including text messages via phone as well as phone calls.', 'interventionNames': ['Other: Arm1: intervention 1 (SMS+call)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The control group will not be subjected to any interventions to increase the adherence to screening.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Arm1: intervention 1 (SMS+call)', 'type': 'OTHER', 'description': 'The intervention will consist in two text messages (one and two weeks after received the screening test, respectively), an automated non-human call or a call made by the administrative assistant (three weeks after received the screening test), and a phone call made by a physician (four weeks after received the screening test)', 'armGroupLabels': ['Interventional Group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'The control group will not be subjected to any interventions to increase the adherence to screening.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4051-401', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Marina Pinheiro MD, PhD, PhD', 'role': 'CONTACT', 'email': 'mpinheiro@icbas.up.pt', 'phone': '+351962654712'}], 'facility': 'Public Health Unit Barcelos/Esposende', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Marina Barroso Pinheiro MD, PhD, PhD', 'role': 'CONTACT', 'email': 'mpinheiro@icbas.up.pt', 'phone': '+351962654712'}, {'name': 'David Nascimento Moreira MD, Master', 'role': 'CONTACT', 'email': 'dnmoreira@ulsbe.min-saude.pt', 'phone': '+351962692301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We plan to share de-identified individual participant data (IPD) that underlie the results reported in this study, including text, tables, and figures. The data will be made available beginning six months after publication and will remain accessible for a period of five years. Access will be granted to researchers who submit a methodologically sound proposal, subject to approval by the study team. Along with the IPD, supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be available. Requests for data access should be directed to Marina Pinheiro, MD, PhD email: mpinheiro@icbas.up.pt.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Local Health Unit Barcelos/Esposende, Public Health Unit', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto de Saude Publica da Universidade do Porto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Public Health Medical Doctor, Local Health Authority', 'investigatorFullName': 'David Nascimento Moreira', 'investigatorAffiliation': 'Instituto de Saude Publica da Universidade do Porto'}}}}