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

NCT ID: NCT01803009

Last Updated: 2014-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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One arm

View CRC RAT and view presentation regarding risk of advanced adenoma

Group Type EXPERIMENTAL

Patient views NCI CRC RAT

Intervention Type BEHAVIORAL

View presentation regarding current chance of having an advanced adenoma

Intervention Type BEHAVIORAL

Interventions

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Patient views NCI CRC RAT

Intervention Type BEHAVIORAL

View presentation regarding current chance of having an advanced adenoma

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Peter Schwartz

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter H. Schwartz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IU School of Medicine

Locations

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Indiana University Health

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1210009869

Identifier Type: -

Identifier Source: org_study_id

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