Computer-Based Tailored or Standard Information for Colorectal Cancer Screening

December 19, 2012 updated by: University of Michigan Rogel Cancer Center

Evaluating a Preference-tailored Intervention to Increase CRC Screening in Primary Care Settings

RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings.

PURPOSE: This randomized clinical trial is studying computer-based tailored information to see how well it works compared with standard information for colorectal cancer screening.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

To evaluate the effectiveness of a preference-tailored (PT) intervention vs standard information (SI) delivered via computer for increasing patients' adherence to colorectal cancer (CRC)-screening guidelines in a randomized controlled trial in two racially/ethnically diverse geographic locations.
To assess the impact of the intervention on patient perceptions of informed-decision making, physician recommendation for CRC screening, decision conflict and satisfaction, and intention to get screened 3 days after a primary care visit.
To conduct a cost-effectiveness analysis of a preference-tailored strategy for increasing CRC screening utilization.

OUTLINE: This is a multicenter study. Patients are randomized by the computer program to 1 of 3 intervention arms.

Arm I (preference-tailored intervention): Patients receive overview information about colorectal cancer (CRC), including graphics and descriptions of the colon and colon polyps. Patients then complete a preference-assessment exercise test by using a specially designed website. A brief description of the test is given at this time, and patients are offered the option to learn more about their preference-matched test. Patients are then given a list of other available CRC-screening tests with a brief description and option to learn more about each test. The program informs them when all information has been viewed. At the time the patients exit the program, or have viewed all the information available, they are asked to choose which test is preferable to receive from a list of existing test options.
Arm II (standard information intervention): Patients receive overview information as in arm I. The patients then use a website listing of the four existing CRC screening test options along with graphical representations. They are allowed to interact with this web page to view basic or more information about any or all of the tests. The program informs them when all the information has been viewed. At this point, patients are asked to choose which test they would prefer to receive from a list of existing test options, as in arm I.
Arm III (usual care): Patients receive usual care and do not receive any extra educational materials. Patients may receive a telephone follow up at 12 months.

Upon completion of the intervention, patients in arms I and II receive a printout to take with them to their upcoming appointment. For those in arm I, this printout will include their top three attributes, their preference-matched test, and their final test choice. For those in arm II, this printout will include a list of the four screening tests but will not list their final test choice.

Patients in arm I and II undergo a 3-day follow-up telephone interview. Medical charts of all patients in all 3 arms are reviewed at 12 months.

Study Type

Observational

Enrollment (Actual)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109-0942
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kelsey-Seybold Clinic, Houston, Tx

Study Coordinator: Bettencourt , Judy ( ) Email: Judith.L.Bettencourt@uth.tmc.e Phone: 713-500-9754

Description

DISEASE CHARACTERISTICS:

At average risk for colorectal cancer (CRC), defined as the following:
- No personal history of CRC, adenomatous colon polyps, or inflammatory bowel disease
- No family history of CRC
Not up-to-date with CRC screening in past year OR have never been screened, defined as
- Up-to-date screening is defined as having completed 1 of the following:
  - Fecal occult blood test within the past 2 years
  - Sigmoidoscopy within the past 5 years
  - Colonoscopy with the past 10 years
  - Double-contrast barium enema within the past 5 years
Patient at San Francisco Community Health Network or at Henry Ford Health System and a member of the Health Alliance Plan

PATIENT CHARACTERISTICS:

Life expectancy ≥ 1 year
No history of inflammatory bowel disease, polyposis, or hereditary nonpolyposis
No severe comorbidity or significantly lowered life expectancy, including any of the following:
- Do not resuscitate (DNR)/do not intubate (DNI) code status
- Metastatic cancer
- End-stage congestive heart failure
- Severe chronic obstructive pulmonary disease
- Coronary artery disease with recent myocardial infarction or unstable angina
- Dementia

PRIOR CONCURRENT THERAPY:

No prior bowel resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence to colorectal cancer screening at 12 months post-intervention Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Elements of informed decision making Time Frame: 12 months	12 months
Knowledge about screening options Time Frame: 12 months	12 months
Decisional conflict and satisfaction Time Frame: 12 months	12 months
Intention to get screened Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Sarah T. Hawley, PhD, MPH, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria