We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computer-Based Tailored or Standard Information for Colorectal Cancer Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955188
First Posted: August 10, 2009
Last Update Posted: December 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose

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.


Condition Intervention
Colorectal Cancer Other: computer-assisted intervention Other: educational intervention Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating a Preference-tailored Intervention to Increase CRC Screening in Primary Care Settings

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Adherence to colorectal cancer screening at 12 months post-intervention [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Elements of informed decision making [ Time Frame: 12 months ]
  • Knowledge about screening options [ Time Frame: 12 months ]
  • Decisional conflict and satisfaction [ Time Frame: 12 months ]
  • Intention to get screened [ Time Frame: 12 months ]

Enrollment: 345
Study Start Date: August 2004
Study Completion Date: May 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955188


Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
University of Michigan Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sarah T. Hawley, PhD, MPH University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00955188     History of Changes
Other Study ID Numbers: CDR0000632080
R01CA131041 ( U.S. NIH Grant/Contract )
P30CA046592 ( U.S. NIH Grant/Contract )
H8000-32900-01
First Submitted: August 7, 2009
First Posted: August 10, 2009
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by University of Michigan Cancer Center:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases