Rural Interventions for Screening Effectiveness (RISE)

The Ohio State University

Status: Completed

Conditions: Breast, Cervical or Colorectal Cancer Screening Needed

Treatments: Behavioral: Educational Intervention via DVD; Behavioral: Educational Intervention-DVD & Telephone Based Navigation; Behavioral: Educational Intervention via brochure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02795104

OSU-16108

R01CA196243 (U.S. NIH Grant/Contract)

NCI-2016-00774 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 985 patients

Sex: Female

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

985 participants in 3 patient groups

Arm I (TIDVD)

Experimental group

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.

Treatment:

Behavioral: Educational Intervention via DVD

Arm II (TIDVD, PN)

Experimental group

Description:

Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.

Treatment:

Behavioral: Educational Intervention-DVD & Telephone Based Navigation

Arm III (UC)

Experimental group

Description:

Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Treatment:

Behavioral: Educational Intervention via brochure