Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

Not Applicable

Completed

• Conditions: Rectal Cancer; Colon Cancer

• Registration Number: NCT01801059
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.

SECONDARY OBJECTIVES:

I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.

II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.

OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.

ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.

ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.

After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• Patient is 50+ years of age
• Patient is in need of CRC screening
• Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
• Patient is not pregnant
• Patient is able to speak, read, and understand English

Exclusion Criteria

• Patient is within CRC screening guidelines
• Patient is at high risk for CRC
• Patient cannot understand English
• Patient cannot complete a CRC screening test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion rate of CRC screening	Up to 2 months	A test of two proportions will be used. If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables. The variables that differ between the two groups will be tested as confounders using risk-factor modeling. Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States