Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-04-17 @ 11:59 PM
Study NCT ID:
NCT02795104
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2016-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rural Interventions for Screening Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ryan.baltic@osumc.edu', 'phone': '614-293-4121', 'title': 'Ryan Baltic', 'organization': 'The Ohio State University Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants could report any and all issues to the study team from enrollment to study exit (1 year) via mail, email, fax, or phone.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD)', 'description': 'TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.', 'otherNumAtRisk': 382, 'deathsNumAtRisk': 382, 'otherNumAffected': 0, 'seriousNumAtRisk': 382, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN)', 'description': 'TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 388, 'otherNumAffected': 0, 'seriousNumAtRisk': 388, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm III Usual Care (UC)', 'description': 'UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 0, 'seriousNumAtRisk': 193, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (TIDVD)', 'description': 'Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.\n\nEducational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch'}, {'id': 'OG001', 'title': 'Arm II (TIDVD, PN)', 'description': 'Educational Intervention-DVD \\& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.\n\nEducational Intervention-DVD \\& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator'}, {'id': 'OG002', 'title': 'Arm III (UC)', 'description': 'Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.\n\nEducational Intervention via brochure: Educational Intervention via brochure:\n\nIn this arm of the educational intervention the participant receives brochures'}], 'classes': [{'title': 'Received All Needed Screenings within 12-months of Enrollment', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Received Any Needed Screening within 12-months of Enrollment', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Will be tested initially with pair-wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions and the UC group on the binary dependent variable (adherence), while adjusting for any potentially confounding covariates. The models will be controlled for any demographic covariate (e.g., age, education) for which the randomized groups differ significantly at baseline using a liberal significance level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used to impute the adherence outcome for participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost Effectiveness of Each Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (TIDVD)', 'description': 'Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.\n\nEducational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch'}, {'id': 'OG001', 'title': 'ARM II (TIDVD, PN)', 'description': 'Educational Intervention-DVD \\& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.\n\nEducational Intervention-DVD \\& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator'}, {'id': 'OG002', 'title': 'ARM III (UC)', 'description': 'Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.\n\nEducational Intervention via brochure: Educational Intervention via brochure:\n\nIn this arm of the educational intervention the participant receives brochures'}], 'classes': [{'categories': [{'measurements': [{'value': '14,462.64', 'groupId': 'OG000'}, {'value': '10,638.20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Cost-effectiveness analysis (CEA) implies a comparison of whether the cost per unit of outcome in one situation exceeds that in another. Unless the outcome measures are comparable, this is not possible. Will be able to examine outcomes of the interventions and the UC group (participants who up to date with all three cancer screening guidelines at 12 month follow-up). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.', 'unitOfMeasure': "USD ('22) per completed UTD screening", 'reportingStatus': 'POSTED', 'populationDescription': 'Same as main outcome. All participants included.'}, {'type': 'SECONDARY', 'title': 'Cost of the Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM I (TIDVD)', 'description': 'Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.\n\nEducational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch'}, {'id': 'OG001', 'title': 'ARM II (TIDVD, PN)', 'description': 'Educational Intervention-DVD \\& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.\n\nEducational Intervention-DVD \\& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator'}, {'id': 'OG002', 'title': 'ARM III (UC)', 'description': 'Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.\n\nEducational Intervention via brochure: Educational Intervention via brochure:\n\nIn this arm of the educational intervention the participant receives brochures'}], 'classes': [{'categories': [{'measurements': [{'value': '326,012.29', 'groupId': 'OG000'}, {'value': '670,841.46', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'In the model implemented in this study, the patient navigators spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the navigator is full-time, data were collected concerning broad categories of time use through a structured time log so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts were used to provide the majority of this information.', 'unitOfMeasure': 'US Dollars (2022)', 'reportingStatus': 'POSTED', 'populationDescription': 'Same as main outcome. All participants of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD)', 'description': 'TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.'}, {'id': 'FG001', 'title': 'Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN)', 'description': 'TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator'}, {'id': 'FG002', 'title': 'Arm III Usual Care (UC)', 'description': 'UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '395'}, {'groupId': 'FG002', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '382'}, {'groupId': 'FG001', 'numSubjects': '388'}, {'groupId': 'FG002', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Determined to be Ineligible with Exit Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}, {'value': '963', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ARM I (TIDVD)', 'description': 'Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.\n\nEducational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch'}, {'id': 'BG001', 'title': 'ARM II (TIDVD, PN)', 'description': 'Educational Intervention-DVD \\& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.\n\nEducational Intervention-DVD \\& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator'}, {'id': 'BG002', 'title': 'ARM III (UC)', 'description': 'Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.\n\nEducational Intervention via brochure: Educational Intervention via brochure:\n\nIn this arm of the educational intervention the participant receives brochures'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age at consent', 'categories': [{'measurements': [{'value': '58.2', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '6.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '382', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}, {'value': '963', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '376', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '936', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'Indiana', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}]}, {'title': 'Ohio', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '585', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-11', 'size': 738379, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-28T12:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 985}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2016-06-06', 'resultsFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-27', 'studyFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms', 'timeFrame': 'Up to 12 months', 'description': 'Will be tested initially with pair-wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions and the UC group on the binary dependent variable (adherence), while adjusting for any potentially confounding covariates. The models will be controlled for any demographic covariate (e.g., age, education) for which the randomized groups differ significantly at baseline using a liberal significance level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used to impute the adherence outcome for participants.'}], 'secondaryOutcomes': [{'measure': 'Cost Effectiveness of Each Intervention', 'timeFrame': 'Up to 12 months', 'description': 'Cost-effectiveness analysis (CEA) implies a comparison of whether the cost per unit of outcome in one situation exceeds that in another. Unless the outcome measures are comparable, this is not possible. Will be able to examine outcomes of the interventions and the UC group (participants who up to date with all three cancer screening guidelines at 12 month follow-up). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.'}, {'measure': 'Cost of the Interventions', 'timeFrame': 'Up to 12 months', 'description': 'In the model implemented in this study, the patient navigators spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the navigator is full-time, data were collected concerning broad categories of time use through a structured time log so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts were used to provide the majority of this information.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RISE'], 'conditions': ['Breast, Cervical or Colorectal Cancer Screening Needed']}, 'referencesModule': {'references': [{'pmid': '37115541', 'type': 'DERIVED', 'citation': 'Champion VL, Paskett ED, Stump TE, Biederman EB, Vachon E, Katz ML, Rawl SM, Baltic RD, Kettler CD, Seiber EE, Xu WY, Monahan PO. Comparative Effectiveness of 2 Interventions to Increase Breast, Cervical, and Colorectal Cancer Screening Among Women in the Rural US: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2311004. doi: 10.1001/jamanetworkopen.2023.11004.'}, {'pmid': '36328234', 'type': 'DERIVED', 'citation': 'Biederman E, Baltic R, Katz ML, Rawl S, Vachon E, Monahan PO, Stump TE, Kettler C, Carter L, Young G, Xu W, Paskett ED, Champion V. Increasing breast, cervical, and colorectal cancer screening among rural women: Baseline characteristics of a randomized control trial. Contemp Clin Trials. 2022 Dec;123:106986. doi: 10.1016/j.cct.2022.106986. Epub 2022 Oct 31.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The James'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.\n\nII. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nArm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.\n\nArm II: Patients engage in TIDVD and PN.\n\nArm III: Patients receive brochures that explain and provide encouragement for cancer screening.\n\nAfter completion of the study, patients are followed up at 2 and 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)\n* Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)\n* Provide informed consent\n* Able to speak/read English\n* Have access to a DVD player or computer that can play DVDs\n\nExclusion Criteria:\n\n* Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis\n* Have a personal history of inflammatory bowel disease (Crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer\n* Have a first degree relative with a history of breast or colorectal cancer\n* Plan to move outside of the country within the next year\n* Reside in a nursing home or other institution\n* Are pregnant or intend to become pregnant during the study period"}, 'identificationModule': {'nctId': 'NCT02795104', 'acronym': 'RISE', 'briefTitle': 'Rural Interventions for Screening Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Comparative Effectiveness of Interventions to Improve Screening Among Rural Women', 'orgStudyIdInfo': {'id': 'OSU-16108'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00774', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'R01CA196243', 'link': 'https://reporter.nih.gov/quickSearch/R01CA196243', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (TIDVD)', 'description': 'Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.', 'interventionNames': ['Behavioral: Educational Intervention via DVD']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (TIDVD, PN)', 'description': 'Educational Intervention-DVD \\& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.', 'interventionNames': ['Behavioral: Educational Intervention-DVD & Telephone Based Navigation']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (UC)', 'description': 'Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.', 'interventionNames': ['Behavioral: Educational Intervention via brochure']}], 'interventions': [{'name': 'Educational Intervention via brochure', 'type': 'BEHAVIORAL', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Educational Intervention via brochure:\n\nIn this arm of the educational intervention the participant receives brochures', 'armGroupLabels': ['Arm III (UC)']}, {'name': 'Educational Intervention via DVD', 'type': 'BEHAVIORAL', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch', 'armGroupLabels': ['Arm I (TIDVD)']}, {'name': 'Educational Intervention-DVD & Telephone Based Navigation', 'type': 'BEHAVIORAL', 'description': 'Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator', 'armGroupLabels': ['Arm II (TIDVD, PN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Electra Paskett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}, {'name': 'Victoria Champion, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'These data will only be used to characterize/compare the group individual to those who are eligible and agree to participate; with those who are ineligible and will not be shared after the completion of the study with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Electra Paskett', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}