Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-21 @ 2:18 PM
Study NCT ID:
NCT03100461
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRC screening completion rate', 'timeFrame': '12-14 Months', 'description': 'Rate of participants who receive CRC screening during study participation'}], 'secondaryOutcomes': [{'measure': 'Cost analysis of each intervention pathway', 'timeFrame': '14 Months', 'description': 'Measure will be calculated by estimating all cost factors in the CRC screening process, include personnel and materials/supplies costs, materials development costs, and time of all study staff involved. Measure represented as a per participant cost to complete screening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Screening', 'Colon Cancer', 'Colon Cancer Screening'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.', 'detailedDescription': 'Colorectal Cancer is preventable and curable but is still the second most common cause of cancer death in the U.S. Minorities and those with low income have more CRC than middle and high income Whites.. They also get fewer CRC screening tests. Low knowledge of CRC screening may, in part, drive this lower test use. We need new ways to improve CRC screening in primary care clinics where many minority and uninsured patients receive health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a home address and access to a working telephone\n* Pass Mini-Cog assessment\n\nExclusion Criteria:\n\n* FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years\n* Acute medical illness,\n* current GI bleed\n* history of adenomatous polyps\n* Colorectal Cancer\n* 1st degree relative with CRC \\< age 60 years\n* inherited polyposis/non-polyposis syndrome\n* inflammatory bowel disease\n* Another household member enrolled in the study'}, 'identificationModule': {'nctId': 'NCT03100461', 'acronym': 'AIMSS', 'briefTitle': 'Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations', 'orgStudyIdInfo': {'id': 'STUDY00002929'}, 'secondaryIdInfos': [{'id': '1R01CA188898-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA188898-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HE + HE', 'description': 'Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.', 'interventionNames': ['Other: Health Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HE + I2', 'description': 'Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.', 'interventionNames': ['Other: I2', 'Other: Health Education']}, {'type': 'EXPERIMENTAL', 'label': 'I2 + I2', 'description': 'Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.', 'interventionNames': ['Other: I2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'I2 + HE', 'description': 'Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.', 'interventionNames': ['Other: I2', 'Other: Health Education']}], 'interventions': [{'name': 'I2', 'type': 'OTHER', 'otherNames': ['Implementation Intentions'], 'description': 'A touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor\'s office, with what supplies, etc.).', 'armGroupLabels': ['HE + I2', 'I2 + HE', 'I2 + I2']}, {'name': 'Health Education', 'type': 'OTHER', 'description': 'Standard of care approach that will provide basic information on CRC screening.', 'armGroupLabels': ['HE + HE', 'HE + I2', 'I2 + HE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Allen Greiner, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}