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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Schwartz, Indiana University
ClinicalTrials.gov Identifier:
NCT01803009
First received: February 15, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Patient views NCI CRC RAT
Behavioral: View presentation regarding current chance of having an advanced adenoma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Satisfaction with NCI CRC RAT [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions

  • Preferred CRC screening test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.


Secondary Outcome Measures:
  • Uptake of CRC screening [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
    Phone call follow up and check of medical record.


Enrollment: 63
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803009

Locations
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Peter H. Schwartz, MD, PhD IU School of Medicine
  More Information

No publications provided

Responsible Party: Peter Schwartz, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01803009     History of Changes
Other Study ID Numbers: 1210009869
Study First Received: February 15, 2013
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board (IRB)

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014