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Completed

NCT Number: NCT01415479

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

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

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Behavioral

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.

Quantitative

Behavioral

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)

Default

Behavioral

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.

Primary outcomes

  1. Intention to undergo CRC screening in the next six months

    Time frame: Day 1: Immediately before and after viewing intervention (at the same visit)

    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 outcomes

  1. Preferred CRC screening test

    Time frame: Day 1: Immediately before and after viewing intervention (at the same visit)

    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).

  2. Knowledge of CRC risk and the benefit of CRC screening

    Time frame: Day 1: Immediately before and after viewing intervention (at the same visit)

    8 True/False questions and 4 Multiple choice questions

  3. Decision conflict

    Time frame: Day 1: Immediately before and after viewing intervention (at the same visit)

    Decision Conflict Scale

  4. Completion of CRC screening

    Time frame: 6 months post-intervention

    Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on personal report and medical record.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 12, 2011
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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