Study Results
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View full resultsBasic Information
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COMPLETED
NA
985 participants
INTERVENTIONAL
2016-11-30
2020-07-31
Brief Summary
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Detailed Description
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I. 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.
II. 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.
OUTLINE: Patients are randomized to 1 of 3 arms.
Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.
Arm II: Patients engage in TIDVD and PN.
Arm III: Patients receive brochures that explain and provide encouragement for cancer screening.
After completion of the study, patients are followed up at 2 and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm I (TIDVD)
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.
Educational Intervention via DVD
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Arm II (TIDVD, PN)
Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.
Educational 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
Arm III (UC)
Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.
Educational Intervention via brochure
Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures
Interventions
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Educational Intervention via brochure
Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures
Educational Intervention via DVD
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Educational 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)
* Provide informed consent
* Able to speak/read English
* Have access to a DVD player or computer that can play DVDs
Exclusion Criteria
* 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
* Have a first degree relative with a history of breast or colorectal cancer
* Plan to move outside of the country within the next year
* Reside in a nursing home or other institution
* Are pregnant or intend to become pregnant during the study period
50 Years
74 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Electra Paskett
Principal Investigator
Principal Investigators
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Electra Paskett, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Victoria Champion, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The James
Other Identifiers
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NCI-2016-00774
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16108
Identifier Type: -
Identifier Source: org_study_id
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