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

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ClinicalTrials.gov Identifier: NCT01803009
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Study Start Date : November 2012
Primary Completion Date : March 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. Stage of readiness to screen [ Time Frame: 1 day ]
    Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions

  5. Preferred CRC screening test [ Time Frame: 1 day ]
    Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.


Secondary Outcome Measures :
  1. Uptake of CRC screening [ Time Frame: 6 months after intervention ]
    Phone call follow up and check of medical record.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peter Schwartz, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01803009     History of Changes
Other Study ID Numbers: 1210009869
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

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