Clinical trial NCT02795104: Rural Interventions for Screening Effectiveness
Official title: Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast, Cervical or Colorectal Cancer Screening Needed
Keywords: RISE
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-09
Enrollment: 985
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms
timeFrame: Up to 12 months
Secondary outcomes:
measure: Cost Effectiveness of Each Intervention
timeFrame: Up to 12 months
measure: Cost of the Interventions
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Victoria Champion, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.