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

Colorectal Cancer Clinical Trial

— CRC-RAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803009
• Other study ID #: 1210009869
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: April 1, 2014
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board (IRB)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Patient views NCI CRC RAT

• View presentation regarding current chance of having an advanced adenoma

Locations

Country	Name	City	State
United States	Indiana University Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Stage of readiness to screen	Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions	1 day	No
Primary	Preferred CRC screening test	Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.	1 day	No
Secondary	Uptake of CRC screening	Phone call follow up and check of medical record.	6 months after intervention	No