Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT01801059
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate of CRC screening', 'timeFrame': 'Up to 2 months', 'description': 'A test of two proportions will be used. If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables. The variables that differ between the two groups will be tested as confounders using risk-factor modeling. Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colon cancer', 'Colorectal Cancer Screening'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.\n\nSECONDARY OBJECTIVES:\n\nI. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.\n\nII. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.\n\nOUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.\n\nARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.\n\nARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.\n\nAfter the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 50+ years of age\n* Patient is in need of CRC screening\n* Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)\n* Patient is not pregnant\n* Patient is able to speak, read, and understand English\n\nExclusion Criteria:\n\n* Patient is within CRC screening guidelines\n* Patient is at high risk for CRC\n* Patient cannot understand English\n* Patient cannot complete a CRC screening test'}, 'identificationModule': {'nctId': 'NCT01801059', 'briefTitle': 'Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)', 'orgStudyIdInfo': {'id': 'OSU-07104'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01922', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I education CRC and CRC screening', 'description': 'Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.', 'interventionNames': ['Other: educational intervention', 'Other: questionnaire administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II education and patient activation intervention', 'description': 'Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.', 'interventionNames': ['Other: educational intervention', 'Other: questionnaire administration']}], 'interventions': [{'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive patient activation intervention by educational video and brochure', 'armGroupLabels': ['Arm I education CRC and CRC screening', 'Arm II education and patient activation intervention']}, {'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive patient activation intervention by educational video', 'armGroupLabels': ['Arm I education CRC and CRC screening', 'Arm II education and patient activation intervention']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I education CRC and CRC screening', 'Arm II education and patient activation intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Mira Katz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mira Katz', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}