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Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool (CRC-RAT)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient views NCI CRC RAT
View presentation regarding current chance of having an advanced adenoma
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

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.
  • Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.

Exclusion Criteria:

  • Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
  • Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
  • Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
  • Inability to speak and read English

Sites / Locations

  • Indiana University Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm

Arm Description

View CRC RAT and view presentation regarding risk of advanced adenoma

Outcomes

Primary Outcome Measures

Satisfaction with NCI CRC RAT
19 Likert-scale questions regarding usability of and satisfaction with the questions asked by the website to assess individual risk and the information provided
Perceived risk of developing CRC
Six Likert-scale questions regarding the subject's perceived risk of developing CRC in next 5 years, 10 years, and lifetime, and compared to others of same age and gender.
Intent to be screened within six months
Three multiple-choice questions regarding intent to be screened in next six months in general or with colonoscopy or stool testing. (Answer options: Definitely, Probably, Probably not, and Definitely not)
Stage of readiness to screen
Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions
Preferred CRC screening test
Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.

Secondary Outcome Measures

Uptake of CRC screening
Phone call follow up and check of medical record.

Full Information

First Posted
February 15, 2013
Last Updated
April 1, 2014
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01803009
Brief Title
Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Acronym
CRC-RAT
Official Title
Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 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
Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One arm
Arm Type
Experimental
Arm Description
View CRC RAT and view presentation regarding risk of advanced adenoma
Intervention Type
Behavioral
Intervention Name(s)
Patient views NCI CRC RAT
Intervention Type
Behavioral
Intervention Name(s)
View presentation regarding current chance of having an advanced adenoma
Primary Outcome Measure Information:
Title
Satisfaction with NCI CRC RAT
Description
19 Likert-scale questions regarding usability of and satisfaction with the questions asked by the website to assess individual risk and the information provided
Time Frame
1 day
Title
Perceived risk of developing CRC
Description
Six Likert-scale questions regarding the subject's perceived risk of developing CRC in next 5 years, 10 years, and lifetime, and compared to others of same age and gender.
Time Frame
1 day
Title
Intent to be screened within six months
Description
Three multiple-choice questions regarding intent to be screened in next six months in general or with colonoscopy or stool testing. (Answer options: Definitely, Probably, Probably not, and Definitely not)
Time Frame
6 months
Title
Stage of readiness to screen
Description
Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions
Time Frame
1 day
Title
Preferred CRC screening test
Description
Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Uptake of CRC screening
Description
Phone call follow up and check of medical record.
Time Frame
6 months after 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. Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites. Exclusion Criteria: Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding. Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment. Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp Inability to speak and read English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H. Schwartz, MD, PhD
Organizational Affiliation
IU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool

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