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Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Schwartz, Indiana University
ClinicalTrials.gov Identifier:
NCT01415479
First received: August 2, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

Fifty thousand people die from colorectal cancer (CRC) every year, making it the second leading cause of death from cancer in the United States. And although there are multiple screening tests that reduce the morbidity and mortality of this disease, less than 60% of eligible individuals are up to date with recommended screening.

One of the challenges to improving screening is helping patients understand the range of approved tests, including colonoscopy, sigmoidoscopy, and stool testing (such as fecal immunochemical testing (FIT)). Patients rarely consider all their options, partly due to the limited time they have to learn about them during busy doctor's visits.

Computer-based presentations, including decision aids, are a promising tool for improving patient understanding in this and other areas, by giving patients significant amounts of information.

But there are important questions about how to design such presentations, including whether they should provide quantitative data about the risks and benefits of screening. Some experts feel that these numbers and graphs are necessary for fully informed decision-making, while others are concerned that they may confuse patients or dissuade them from screening.

The investigators have created and pilot tested a computer-based presentation of quantitative information about CRC screening. The investigators found that subjects who viewed the program in a non-healthcare setting exhibited significantly increased interest in screening. In addition, the investigators tested a version of the program that includes a "nudge" towards stool testing with FIT, as a way of encouraging individuals who are confused to undergo some form of screening. In our testing, receiving the nudge was associated with a significant increase in interest in FIT.

The investigators now seek to conduct a randomized, controlled study of our computer-based presentation with Clarian patients who are due for CRC screening. All subjects will first view a general video about CRC screening and then will be randomly placed into four groups (using a 2x2 design), to receive quantitative information (or not), and a nudge towards FIT (or not).

The results will determine whether a presentation of quantitative information can increase patient understanding, quality of decision-making, and uptake of CRC screening. The results will serve as pilot data for a larger, externally funded study of the effect of individualized ("personalized") quantitative information in this area


Condition Intervention
Colonic Neoplasms
 Behavioral: Control
Behavioral: Quantitative
Behavioral: Default

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Intention to undergo CRC screening in the next six months [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ] [ Designated as safety issue: No ]
    Multiple choice question assessing subject's interest in getting a colon screening test in the next 6 months (choices: definitely, probably, may or may not, probably not, or definitely not).


Secondary Outcome Measures:
  • Preferred CRC screening test [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ] [ Designated as safety issue: No ]
    Multiple choice question: which colon test the subject would choose if he or she was having one (choices: stool test, colonoscopy, other, or don't know).

  • Knowledge of CRC risk and the benefit of CRC screening [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ] [ Designated as safety issue: No ]
    8 True/False questions and 4 Multiple choice questions

  • Decision conflict [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ] [ Designated as safety issue: No ]
    Decision Conflict Scale

  • Completion of CRC screening [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on personal report and medical record.
Estimated Enrollment: 212
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quantitative

Subjects view:

  1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
  2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
 Behavioral: Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Behavioral: Quantitative
Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Experimental: Default

Subjects view:

  1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
  2. Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT).
 Behavioral: Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Behavioral: Default
Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the "Default" intervention since it attempts to shift the "default" choice from "no screening" to FIT.
Experimental: Quantitative + Default

Subjects view:

  1. Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
  2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
  3. Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT).
 Behavioral: Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
Behavioral: Quantitative
Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
Behavioral: Default
Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the "Default" intervention since it attempts to shift the "default" choice from "no screening" to FIT.
Active Comparator: Control
Subjects view a computer-based presentation regarding colorectal cancer (CRC) and available screening tests for CRC, primarily a video produced by the American Cancer Society.
 Behavioral: Control
Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.

  Eligibility
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-75 years old
  • No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years or fecal occult blood testing (including FIT) in last 1 year, and
  • Upcoming appointment with primary care physician at three primary care sites of IU Health (previously sites of the Methodist Medical Group (MMG)): Internal Medicine and Pediatrics Fishers, Family & Internal Medicine South, or Family & Internal Medicine East Washington.

Exclusion Criteria:

  • Undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
  • Diagnosis or medical history conferring elevated risk for CRC including previous polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC, or
  • Inability to speak English and to fill out a questionnaire written in English.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415479

Locations
United States, Indiana
IU Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Peter H. Schwartz, MD, PhD Indiana University School of Medicine
  More Information

Responsible Party: Peter Schwartz, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01415479     History of Changes
Other Study ID Numbers: CCCDA-10-085-01-A  VFR-320-A 
Study First Received: August 2, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Colon cancer
Screening
Decision-making

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

ClinicalTrials.gov processed this record on September 23, 2016