Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-20 @ 12:28 PM
Study NCT ID:
NCT02795104
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rural Interventions for Screening Effectiveness
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-00774 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| R01CA196243 | NIH | None | https://reporter.nih.gov/quic… | View |