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Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
educational intervention
questionnaire administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer focused on measuring colon cancer, Colorectal Cancer Screening

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I education CRC and CRC screening

Arm II education and patient activation intervention

Arm Description

Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.

Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
October 14, 2014
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01801059
Brief Title
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer
Official Title
Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
colon cancer, Colorectal Cancer Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I education CRC and CRC screening
Arm Type
Active Comparator
Arm Description
Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.
Arm Title
Arm II education and patient activation intervention
Arm Type
Experimental
Arm Description
Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive patient activation intervention by educational video and brochure
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive patient activation intervention by educational video
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Completion rate of CRC screening
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mira Katz
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

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