Breast Cancer Clinical Trial

Rural Interventions for Screening Effectiveness

Summary

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.

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Full Description

PRIMARY OBJECTIVES:

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)
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 or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

985

Study ID:

NCT02795104

Recruitment Status:

Completed

Sponsor:

Ohio State University Comprehensive Cancer Center

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There is 1 Location for this study

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Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

985

Study ID:

NCT02795104

Recruitment Status:

Completed

Sponsor:


Ohio State University Comprehensive Cancer Center

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