Rural Interventions for Screening Effectiveness



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 74
Updated:3/15/2019
Start Date:October 2016
End Date:September 2020
Contact:The Ohio State University Comprehensive Cancer Center
Email:cathy.tatum@osumc.edu
Phone:877-304-2273

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Comparative Effectiveness of Interventions to Improve Screening Among Rural Women

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.

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.

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
We found this trial at
2
sites
Columbus, Ohio 43210
Principal Investigator: Electra D. Paskett
Phone: 614-293-3917
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Columbus, OH
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Columbus, Ohio 43210
Principal Investigator: Electra D. Paskett
Phone: 614-293-3917
?
mi
from
Columbus, OH
Click here to add this to my saved trials