Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT02360605
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2015-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health Literacy Interventions to Overcome Disparities in CRC Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carnol@lsuhsc.edu', 'phone': '318-675-4324', 'title': 'Dr. Connie Arnold', 'organization': 'LSUShreveport'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 0, 'seriousNumAtRisk': 308, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prevention Coordinator Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.\n\nprevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 0, 'seriousNumAtRisk': 306, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Initial CRC Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.'}, {'id': 'OG001', 'title': 'Prevention Coordinator Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.\n\nprevention coordinator: patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed'}], 'classes': [{'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\\<0.05', 'groupDescription': 'FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after receipt of FIT kit', 'description': 'A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Repeat CRC Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.'}, {'id': 'OG001', 'title': 'Prevention Coordinator Arm', 'description': 'Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.\n\nprevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.\n\nAnnual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\\<0.05', 'groupDescription': 'Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'between 12 and 18 months of previous screen, 2 years overall', 'description': 'Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 2 primary outcome is number of participants who return a FIT for 2 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '620 participants enrolled - 6 withdrew the day after enrollment - 614 participants at baseline. Of these, 44 had a positive FIT result and were excluded from the second FIT screening and 2 withdrew after year 1 resulting in a sample size of 568 for the 2nd year screening analysis. All participants who were enrolled were included in the final analysis with the exception of the 44 with a positive FIT test in Year 1 and the 2 lost-to-follow-up.'}, {'type': 'PRIMARY', 'title': 'Repeat Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.'}, {'id': 'OG001', 'title': 'Prevention Coordinator Arm', 'description': 'Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.\n\nprevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.\n\nAnnual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\\<0.05', 'groupDescription': 'Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'between 12 and 18 months of previous screen, 2 years overall', 'description': 'Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 3 primary outcome is number of participants who return a FIT all 3 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '531 eligible for year 3 screening - 614 baseline minus \\[Year 1 FIT positive (n=44) + Lost to follow-up in year 2 (n=2) + Year 2 FIT positive (n=17) =Lost to follow-up in year 3 (n=20)\\]'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.'}, {'id': 'FG001', 'title': 'Prevention Coordinator Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.\n\nPrevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '291'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occurred from February 2015-October 2016 in four Federally Qualified Health Centers in rural South Louisiana. Clinic staff asked consecutive patients aged 50 to 75 presenting to the clinic for a scheduled routine primary care visit if they were interested in participating in a CRC screening study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Automated Telephone Reminder Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.\n\nautomated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.'}, {'id': 'BG001', 'title': 'Prevention Coordinator Arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.\n\nPrevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.\n\nYears 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '6 patients withdrew within a day of enrolling and therefore were not included in the CRC analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-09', 'size': 289755, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-10T00:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2015-02-05', 'resultsFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-01', 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial CRC Screening', 'timeFrame': '6 months after receipt of FIT kit', 'description': 'A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.'}, {'measure': 'Repeat CRC Screening', 'timeFrame': 'between 12 and 18 months of previous screen, 2 years overall', 'description': 'Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 2 primary outcome is number of participants who return a FIT for 2 years.'}, {'measure': 'Repeat Screening', 'timeFrame': 'between 12 and 18 months of previous screen, 2 years overall', 'description': 'Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 3 primary outcome is number of participants who return a FIT all 3 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer screening', 'low literacy', 'community clinics', 'Fecal Immunochemical Test'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '18384785', 'type': 'BACKGROUND', 'citation': 'Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ; American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology. 2008 May;134(5):1570-95. doi: 10.1053/j.gastro.2008.02.002. Epub 2008 Feb 8.'}, {'pmid': '19998273', 'type': 'BACKGROUND', 'citation': 'Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.'}, {'pmid': '20388702', 'type': 'BACKGROUND', 'citation': 'Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Keating NL, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. National Institutes of Health state-of-the-science conference statement: Enhancing use and quality of colorectal cancer screening. Ann Intern Med. 2010 May 18;152(10):663-7. doi: 10.7326/0003-4819-152-10-201005180-00237. Epub 2010 Apr 13. No abstract available.'}, {'pmid': '18725837', 'type': 'BACKGROUND', 'citation': 'Taplin SH, Haggstrom D, Jacobs T, Determan A, Granger J, Montalvo W, Snyder WM, Lockhart S, Calvo A. Implementing colorectal cancer screening in community health centers: addressing cancer health disparities through a regional cancer collaborative. Med Care. 2008 Sep;46(9 Suppl 1):S74-83. doi: 10.1097/MLR.0b013e31817fdf68.'}, {'pmid': '20613704', 'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening among adults aged 50-75 years - United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Jul 9;59(26):808-12.'}, {'pmid': '11296623', 'type': 'BACKGROUND', 'citation': 'Davis TC, Dolan NC, Ferreira MR, Tomori C, Green KW, Sipler AM, Bennett CL. The role of inadequate health literacy skills in colorectal cancer screening. Cancer Invest. 2001;19(2):193-200. doi: 10.1081/cnv-100000154.'}, {'pmid': '12018928', 'type': 'BACKGROUND', 'citation': 'Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health literacy and cancer communication. CA Cancer J Clin. 2002 May-Jun;52(3):134-49. doi: 10.3322/canjclin.52.3.134.'}, {'pmid': '15226329', 'type': 'BACKGROUND', 'citation': 'Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.'}, {'pmid': '20064288', 'type': 'BACKGROUND', 'citation': 'Burt RW. Strategies for colon cancer screening with considerations of cost and access to care. J Natl Compr Canc Netw. 2010 Jan;8(1):2-5. doi: 10.6004/jnccn.2010.0002. No abstract available.'}, {'pmid': '15207986', 'type': 'BACKGROUND', 'citation': "O'Malley AS, Beaton E, Yabroff KR, Abramson R, Mandelblatt J. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Prev Med. 2004 Jul;39(1):56-63. doi: 10.1016/j.ypmed.2004.02.022."}, {'pmid': '18304342', 'type': 'BACKGROUND', 'citation': 'Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.'}, {'pmid': '16307620', 'type': 'BACKGROUND', 'citation': 'Greiner KA, Born W, Nollen N, Ahluwalia JS. Knowledge and perceptions of colorectal cancer screening among urban African Americans. J Gen Intern Med. 2005 Nov;20(11):977-83. doi: 10.1111/j.1525-1497.2005.00165.x.'}, {'pmid': '22757955', 'type': 'BACKGROUND', 'citation': 'Davis TC, Arnold CL, Rademaker AW, Platt DJ, Esparza J, Liu D, Wolf MS. 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Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial. Am J Prev Med. 2009 Jun;36(6):459-67. doi: 10.1016/j.amepre.2009.01.032. Epub 2009 Apr 11.'}, {'pmid': '19774423', 'type': 'BACKGROUND', 'citation': 'Lee JK, Reis V, Liu S, Conn L, Groessl EJ, Ganiats TG, Ho SB. Improving fecal occult blood testing compliance using a mailed educational reminder. J Gen Intern Med. 2009 Nov;24(11):1192-7. doi: 10.1007/s11606-009-1087-5. Epub 2009 Sep 23.'}, {'pmid': '20508529', 'type': 'BACKGROUND', 'citation': 'Mosen DM, Feldstein AC, Perrin N, Rosales AG, Smith DH, Liles EG, Schneider JL, Lafata JE, Myers RE, Kositch M, Hickey T, Glasgow RE. Automated telephone calls improved completion of fecal occult blood testing. Med Care. 2010 Jul;48(7):604-10. doi: 10.1097/MLR.0b013e3181dbdce7.'}]}, 'descriptionModule': {'briefSummary': "In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual colorectal cancer (CRC) screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of this study is to compare the effectiveness of two distinct follow-up strategies to promote CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2. Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both follow-up strategies to investigate implementation and barriers 4. Determine if the effects of either strategy vary by patients' literacy skills. 5. Explore patient characteristics associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time between study arms.", 'detailedDescription': "The investigators objective is to compare the effectiveness of two distinct follow-up strategies to promote colorectal cancer screening: a prevention coordinator (PC) approach vs. an automated telephone reminder (ATR) system. The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project \\[R01CA115869\\] by adding a follow-up strategy to the health literacy intervention. In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients' completion of initial and annual CRC screening using Fecal Immunochemical Test (FIT).\n\nSubstantial evidence shows that routine screening can prevent colorectal cancer (CRC) or detect it at an early stage, reducing related mortality. While overall CRC screening rates in the US are increasing, rates remain persistently low among uninsured and low-income individuals, those with fewer years of education, and racial/ethnic minorities. Low health literacy has been linked to cancer screening noncompliance, higher rates of advanced stage of presentation of disease and health disparities. In response, the Department of Health and Human Services has called for health information and services that are accurate, accessible, and actionable as well as culturally appropriate.\n\nThis study will implement a two-arm, randomized controlled trial with low income, underinsured patients in federally qualified health centers (FQHCs) to evaluate and compare the effectiveness of PC and ATR follow-up strategies to increase CRC screening. All patients recruited to the study will receive evidence-based, literacy appropriate screening materials developed using health literacy 'best practices' and a simplified FIT kit. Use of these materials has been shown to significantly increase CRC screening rates in the investigators ongoing study. Patients will be randomized to receive either: 1) the PC follow-up strategy, in which a PC personally reminds patients to complete and mail FIT kits, and perceived barriers to screening are discussed and addressed; or 2) the ATR follow-up strategy, in which an automated system electronically encourages patients to complete and mail FIT kits using plain language messages. The effectiveness of these two approaches will be compared at 12 and 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a patient of the identified clinics,\n2. age 50 to 75 (based on American Cancer Society (ACS) guidelines), and\n3. can speak and understand English\n\nExclusion Criteria:\n\n1. previous history of cancer other than non-melanoma skin cancer,\n2. up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),\n3. a first relative family history that requires a more complete history and possible colonoscopy because of their risk factor (these patients will be referred to their provider for follow-up),\n4. an uncorrectable hearing or visual impairment, or\n5. too ill to participate.'}, 'identificationModule': {'nctId': 'NCT02360605', 'briefTitle': 'Health Literacy Interventions to Overcome Disparities in CRC Screening', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center Shreveport'}, 'officialTitle': 'Health Literacy Interventions to Overcome Disparities in CRC Screening', 'orgStudyIdInfo': {'id': 'RSG-13-021-01 - CPPB'}, 'secondaryIdInfos': [{'id': 'RSG-13-021-01 - CPPB', 'type': 'OTHER_GRANT', 'domain': 'American Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'automated telephone reminder arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.', 'interventionNames': ['Behavioral: automated telephone reminder', 'Behavioral: Health literacy appropriate education and demonstration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prevention coordinator arm', 'description': 'Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.', 'interventionNames': ['Behavioral: prevention coordinator', 'Behavioral: Health literacy appropriate education and demonstration']}], 'interventions': [{'name': 'automated telephone reminder', 'type': 'BEHAVIORAL', 'description': 'The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.', 'armGroupLabels': ['automated telephone reminder arm']}, {'name': 'prevention coordinator', 'type': 'BEHAVIORAL', 'description': 'The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.', 'armGroupLabels': ['prevention coordinator arm']}, {'name': 'Health literacy appropriate education and demonstration', 'type': 'BEHAVIORAL', 'description': 'The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.', 'armGroupLabels': ['automated telephone reminder arm', 'prevention coordinator arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center Shreveport', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Loyola University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}