Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03884868
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two consecutive study groups (no-concurrent).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of distress experienced by patients', 'timeFrame': 'Minute 0 (before the nurse visit)', 'description': 'Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)'}, {'measure': 'Grade of distress experienced by patients', 'timeFrame': 'at 30 minutes (after the nurse visit)', 'description': 'Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)'}], 'secondaryOutcomes': [{'measure': 'Grade of understanding of the information reported by patients', 'timeFrame': 'at 30 minutes (after the nurse visit)', 'description': 'Grade of understanding of the information measured with a visual analogical scale (0-no understanding, 10- high understanding)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer screening', 'Iconographies', 'Risk communication', 'Patient medical knowledge'], 'conditions': ['Colo-rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Background: Participants in the colon and rectal cancer (CRC) screening program that have a positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who explains the meaning of the positive test and the need to perform a colonoscopy. Having a positive result in the screening test can have a negative psychological impact on patients causing anguish.\n\nObjective: To evaluate whether the use of iconographies to communicate the risks of possible diagnoses to patients with positive FIT improves the understanding of the information and reduces the degree of anguish.\n\nMethods: Quasi-experimental pre-post intervention study with a control group. 240 individuals (men and women between 50-69 years of age, with a positive FIT result attending the nursing visit) will be included in two non-concurrent study groups (120 individuals per group). The control group will receive the nurse visit as usual. For the intervention group, the nurse will use iconographies to communicate the risk of the different possible diagnoses and the risk of complications of the colonoscopy. The degree of distress (Distress Thermometer and a scale of emotion-faces) will be measured before and after the visit and the understanding of the information (visual analog scale) after the visit. The degree of distress between the control group and intervention group will be compared.\n\nIf the results are favorable, the systematic use of iconographies can be implemented in the nursing screening visit and be extended to other Screening Units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men AND\n* between 50 and 69 years of age AND\n* who participate in the colorectal cancer screening program and have a positive result in the FIT AND\n* who attend the nursing visit.\n\nExclusion Criteria:\n\n* People who do not understand Catalan or Spanish OR\n* with cognitive deterioration that prevents them from answering a questionnaire OR\n* who do not know how to read or write.'}, 'identificationModule': {'nctId': 'NCT03884868', 'briefTitle': "Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program", 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': "Use of Iconographies for Risk Communication and Reduction of Patient's Anxiety During the Nurse Information Visit in the Colorectal Cancer Screening Program", 'orgStudyIdInfo': {'id': '20198501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Regular nursing visit: 1. Explanation of the meaning of a positive result in the FIT. 2. Explanation of the need to perform a colonoscopy with sedation. 3. Anamnesis. 4. Agreement of the day and hour to perform the colonoscopy. 5. Explanation of the diet and delivery of preparation for the preparation of the colon.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In addition of the regular nursing visit: the nurse will use iconographies specially designed to communicate the risk of the different possible diagnoses and the complications of the colonoscopy. Because the risks are different according to sex and age, specific iconographies will be developed from the data available in the first screening round.', 'interventionNames': ['Other: Iconographies to communicate risks']}], 'interventions': [{'name': 'Iconographies to communicate risks', 'type': 'OTHER', 'description': 'Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc Taulí Hospital Universitari', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Pilar López-López, DUI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporació Sanitaria Parc Taulí'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pilar Lopez-Lopez', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}