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

Overview

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.

Full Title of Study: “Patients’ Opinions and Responses to the National Cancer Institute’s Colorectal Cancer Risk Assessment Tool”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Behavioral: Patient views NCI CRC RAT
  • Behavioral: View presentation regarding current chance of having an advanced adenoma

Arms, Groups and Cohorts

  • Experimental: One arm
    • View CRC RAT and view presentation regarding risk of advanced adenoma

Clinical Trial Outcome Measures

Primary Measures

  • Satisfaction with NCI CRC RAT
    • Time Frame: 1 day
    • 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
    • Time Frame: 1 day
    • 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
    • Time Frame: 6 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
    • Time Frame: 1 day
    • Measure calculated from patient’s answers on 5 multiple-choice or Likert-scale questions
  • Preferred CRC screening test
    • Time Frame: 1 day
    • Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.

Secondary Measures

  • Uptake of CRC screening
    • Time Frame: 6 months after intervention
    • Phone call follow up and check of medical record.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Schwartz, Associate Professor of Medicine – Indiana University
  • Overall Official(s)
    • Peter H. Schwartz, MD, PhD, Principal Investigator, IU School of Medicine

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