Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening
|
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. |
| ClinicalTrials.gov Identifier: NCT01415479 |
|
Recruitment Status
:
Completed
First Posted
: August 12, 2011
Last Update Posted
: April 30, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colonic Neoplasms | Behavioral: Control Behavioral: Quantitative Behavioral: Default | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 212 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Trial of a Computer-Based Presentation of Quantitative Information About Colorectal Cancer Screening |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Quantitative
Subjects view:
|
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:
|
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:
|
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.
|
- 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).
- 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).
- 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
- Decision conflict [ Time Frame: Day 1: Immediately before and after viewing intervention (at the same visit) ]Decision Conflict Scale
- 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.
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 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT01415479
| United States, Indiana | |
| IU Health | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Peter H. Schwartz, MD, PhD | Indiana University School of Medicine |
| 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 ( Other Grant/Funding Number: IU Health Values Fund ) |
| First Posted: | August 12, 2011 Key Record Dates |
| Last Update Posted: | April 30, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Peter Schwartz, 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 |