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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Patient views NCI CRC RAT; Behavioral: View presentation regarding current chance of having an advanced adenoma

• Registration Number: NCT01803009
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-15
• Primary Completion: 2013-03
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Study Completion: 2013-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm	Patient views NCI CRC RAT	View CRC RAT and view presentation regarding risk of advanced adenoma
One arm	View presentation regarding current chance of having an advanced adenoma	View CRC RAT and view presentation regarding risk of advanced adenoma

Primary Outcome Measures

Name	Time	Method
Stage of readiness to screen	1 day	Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions
Perceived risk of developing CRC	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	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)
Preferred CRC screening test	1 day	Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.
Satisfaction with NCI CRC RAT	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

Secondary Outcome Measures

Name	Time	Method
Uptake of CRC screening	6 months after intervention	Phone call follow up and check of medical record.

Trial Locations

Locations (1)

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States