NCT01803009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

February 15, 2013

Last Update Submit

April 1, 2014

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Stage of readiness to screen

    Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions

    1 day

  • Preferred CRC screening test

    Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.

    1 day

Secondary Outcomes (1)

  • Uptake of CRC screening

    6 months after intervention

Study Arms (1)

One arm

EXPERIMENTAL

View CRC RAT and view presentation regarding risk of advanced adenoma

Behavioral: Patient views NCI CRC RATBehavioral: View presentation regarding current chance of having an advanced adenoma

Interventions

Patient views NCI CRC RATBEHAVIORAL
One arm
View presentation regarding current chance of having an advanced adenomaBEHAVIORAL
One arm

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Peter H. Schwartz, MD, PhD

    IU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 15, 2013

First Posted

March 4, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

US(1)