Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05690958
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2088}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline'}, {'measure': 'Gender', 'timeFrame': 'Baseline'}, {'measure': 'Education', 'timeFrame': 'Baseline'}, {'measure': 'Current GERD symptoms', 'timeFrame': '7 days', 'description': 'Reflux Disease Questionnaire (RDQ)'}, {'measure': 'Marital status', 'timeFrame': 'Baseline'}, {'measure': 'Ethnicity', 'timeFrame': 'Baseline'}, {'measure': 'Previous upper endoscopy experience', 'timeFrame': 'Baseline'}, {'measure': 'Personal history of cancer', 'timeFrame': 'Baseline'}, {'measure': 'Knowing someone affected by esophageal cancer', 'timeFrame': 'Baseline'}, {'measure': 'General cancer worry', 'timeFrame': 'Baseline', 'description': "Lerman's cancer worry scale (CWS)"}, {'measure': 'Perceived risk of EAC', 'timeFrame': 'Baseline', 'description': 'Item adapted from HINTS survey'}, {'measure': 'General screening intent and beliefs about cancer screening', 'timeFrame': 'Baseline', 'description': 'Item adapted from screening module of awareness and beliefs about cancer (ABC) measure'}, {'measure': 'Anticipated discomfort during the screening test', 'timeFrame': 'Baseline', 'description': '7-point Likert scale'}, {'measure': 'Acceptability of screening test accuracy', 'timeFrame': 'Baseline', 'description': '7-point Likert scale'}], 'primaryOutcomes': [{'measure': 'Intended uptake of EAC screening', 'timeFrame': 'Baseline', 'description': "Participants will be informed about BE/EAC screening. Participants will also be informed about using upper endoscopy for this purpose and 1 out of 3 alternative hypothetical screening scenario's (transnasal endoscopy, ingestible cell-collection device, or breath analysis. Subsequently, participants will be asked if they intend to attend upper endoscopy and the alternative test if they were invited."}], 'secondaryOutcomes': [{'measure': 'Views on the organization of EAC screening', 'timeFrame': 'Baseline', 'description': 'Various items that are based on qualitative focus group results on the topic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Barrett Esophagus', 'Barrett Adenocarcinoma', 'Esophageal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38619114', 'type': 'DERIVED', 'citation': "Sijben J, Rainey L, Maas F, Broeders MJM, Siersema PD, Peters Y. The Public's Intended Uptake of Hypothetical Esophageal Adenocarcinoma Screening Scenarios: A Nationwide Survey. Am J Gastroenterol. 2024 Sep 1;119(9):1802-1812. doi: 10.14309/ajg.0000000000002812. Epub 2024 Apr 15."}]}, 'descriptionModule': {'briefSummary': "Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Public preferences should also be considered on the organizational level to guarantee client-centered decision-making in the design of the screening process.\n\nObjective: This study will examine Dutch individuals' intended uptake of EAC screening, including factors that predict uptake, and their views on its organization.\n\nStudy design: Cross-sectional population-based survey. Study population: Dutch individuals aged 45-75 years. The required sample size is 2088 and 8350 individuals will be invited based on an assumed participation rate of 25%.\n\nMethods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.\n\nMain study parameters/endpoints: The primary outcome of the study is the intended uptake of EAC screening (strong vs weak). Secondary study endpoints are the perceived need for consultation, perceived need for general education campaigns, acceptability of risk stratification scenarios, and acceptability of using health care resources for EAC screening.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 15 to 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "A sample will be drawn from the Dutch population registry, the 'Basisregistratie Personen' (BRP), using simple random sampling.", 'genderDescription': 'All genders are included in the study. We provide a non-binairy answer option for gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 45 to 75 years\n\nExclusion Criteria:\n\n* Previous diagnosis of EAC.\n* Unable to provide informed consent.\n* Unable to fill out the digital survey.'}, 'identificationModule': {'nctId': 'NCT05690958', 'acronym': 'ACCEPT-survey', 'briefTitle': "Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey", 'orgStudyIdInfo': {'id': '111597'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Filling in a survey'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'jasmijn sijben', 'role': 'CONTACT', 'email': 'jasmijn.sijben@radboudumc.nl', 'phone': '+31621193178'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Jasmijn D Sijben, drs', 'role': 'CONTACT', 'email': 'jasmijn.sijben@radboudumc.nl', 'phone': '+31629061198'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}