Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Rural Interventions for Screening Effectiveness

Protocol: OSU-16108

Full Title

Comparative Effectiveness of Interventions to Improve Screening among Rural Women:Rural Interventions for Screening Effectiveness (RISE)

Purpose

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.

Study Objective

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.

Are you eligible?

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

Breast Cancer