Clinical trial NCT01415479: Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening
Official title: Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Colon cancer
Screening
Decision-making
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 212
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Intention to undergo CRC screening in the next six months
timeFrame: Day 1: Immediately before and after viewing intervention (at the same visit)
Secondary outcomes:
measure: Preferred CRC screening test
timeFrame: Day 1: Immediately before and after viewing intervention (at the same visit)
measure: Knowledge of CRC risk and the benefit of CRC screening
timeFrame: Day 1: Immediately before and after viewing intervention (at the same visit)
measure: Decision conflict
timeFrame: Day 1: Immediately before and after viewing intervention (at the same visit)
measure: Completion of CRC screening
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Peter H. Schwartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz PH, Perkins SM, Schmidt KK, Muriello PF, Althouse S, Rawl SM. Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. Med Decis Making. 2017 Aug;37(6):688-702. doi: 10.1177/0272989X17698678. Epub 2017 Apr 11.