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OpenTrials
Completed

NCT Number: NCT01803009

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient views NCI CRC RAT

Behavioral

View presentation regarding current chance of having an advanced adenoma

Behavioral

Primary outcomes

  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 outcomes

  1. Uptake of CRC screening

    Time frame: 6 months after intervention

    Phone call follow up and check of medical record.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: CRC-RAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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