Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

Rectal Cancer Clinical Trial

Official title:

Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801059
• Other study ID #: OSU-07104
• Secondary ID: NCI-2012-01922
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: October 14, 2014
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Intervention

Other:
• educational intervention
Receive patient activation intervention by educational video and brochure
• educational intervention
Receive patient activation intervention by educational video
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of CRC screening	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.	Up to 2 months	No

External Links

•   Jamesline