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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Patient views NCI CRC RAT; Behavioral: View presentation regarding current chance of having an advanced adenoma

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One arm; View CRC RAT and view presentation regarding risk of advanced adenoma	Behavioral: Patient views NCI CRC RAT; Behavioral: View presentation regarding current chance of having an advanced adenoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day
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.	1 day
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)	6 months
Stage of readiness to screen	Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions	1 day
Preferred CRC screening test	Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of CRC screening	Phone call follow up and check of medical record.	6 months after intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Peter H. Schwartz, MD, PhD, IU School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 3, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 1210009869