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

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Quantitative
Default
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonic Neoplasms focused on measuring Colon cancer, Screening, Decision-making

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IU Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Quantitative

Default

Quantitative + Default

Control

Arm Description

Subjects view: 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. 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)

Subjects view: 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. 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).

Subjects view: 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. 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) 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).

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.

Outcomes

Primary Outcome Measures

Intention to undergo CRC screening in the next six months
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
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
8 True/False questions and 4 Multiple choice questions
Decision conflict
Decision Conflict Scale
Completion of CRC screening
Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on personal report and medical record.

Full Information

First Posted
August 2, 2011
Last Updated
April 29, 2013
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01415479
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colon cancer, Screening, Decision-making

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quantitative
Arm Type
Experimental
Arm Description
Subjects view: 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. 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)
Arm Title
Default
Arm Type
Experimental
Arm Description
Subjects view: 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. 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).
Arm Title
Quantitative + Default
Arm Type
Experimental
Arm Description
Subjects view: 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. 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) 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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quantitative
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Default
Intervention Description
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 Outcome Measure Information:
Title
Intention to undergo CRC screening in the next six months
Description
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).
Time Frame
Day 1: Immediately before and after viewing intervention (at the same visit)
Secondary Outcome Measure Information:
Title
Preferred CRC screening test
Description
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).
Time Frame
Day 1: Immediately before and after viewing intervention (at the same visit)
Title
Knowledge of CRC risk and the benefit of CRC screening
Description
8 True/False questions and 4 Multiple choice questions
Time Frame
Day 1: Immediately before and after viewing intervention (at the same visit)
Title
Decision conflict
Description
Decision Conflict Scale
Time Frame
Day 1: Immediately before and after viewing intervention (at the same visit)
Title
Completion of CRC screening
Description
Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on personal report and medical record.
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H. Schwartz, MD, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28398836
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.
Results Reference
derived

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

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