R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492049
Recruitment Status : Active, not recruiting
First Posted : December 14, 2011
Last Update Posted : May 2, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

December 12, 2011
December 14, 2011
May 2, 2017
August 2012
August 2018   (Final data collection date for primary outcome measure)
Colorectal cancer screening (CRCS) Rate of Participants [ Time Frame: 24 months for study duration ]
CRCS rates in the patient decision aid and control subjects based on medical record reviews, physician orders for screening endoscopy after the baseline visit also from medical record reviews, and intentions to complete CRCS based on self-report.
Same as current
Complete list of historical versions of study NCT01492049 on Archive Site
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R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.

Baseline Visit:

If you agree to take part in this study, you will complete a questionnaire that asks demographic questions (such as your age and sex) and questions about colorectal cancer. It should take about 10-15 minutes to complete.

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a program on Essential Hypertension.

You will watch the program on a laptop in the clinic. The program is about 30 minutes long. After you watch the program, you will complete a questionnaire that asks what you thought about the program and some questions about understanding medical information. It should take about 5-10 minutes to complete the questionnaire.

You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone. The call should last about 20-25 minutes. You will be asked if you discussed colorectal cancer screening tests with your doctor, your preferences for colorectal cancer screening tests, and if any colorectal cancer screening tests were ordered.

At Month 3, your medical record will be reviewed by the study staff.

Length of Study:

You will be off study after your medical record is reviewed at Month 3.

This is an investigational study.

Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study. All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold outpatient clinics.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Colorectal Neoplasms
  • Behavioral: CRCS patient decision aid (PtDA) video
    Participant views PtDA program video in same room as research assistant who offers instruction as needed.
  • Behavioral: Questionnaires
    Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
    Other Name: survey
  • Behavioral: Essential Hypertension video
    Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
  • Experimental: Patient Decision Aid (PtDA)
    Participants view Patient decision aid (PtDA) video.
    • Behavioral: CRCS patient decision aid (PtDA) video
    • Behavioral: Questionnaires
  • Active Comparator: Control
    Participants view a video on Essential Hypertension.
    • Behavioral: Questionnaires
    • Behavioral: Essential Hypertension video
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
August 2018
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients
  2. 49 -75 years of age
  3. English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)

Exclusion Criteria:

  1. History of colorectal cancer
  2. History of polyps
  3. Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
  4. Family history of colorectal cancer in a first degree relative
  5. Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years
Sexes Eligible for Study: All
49 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R21CA132669 ( U.S. NIH Grant/Contract )
NCI-2015-01899 ( Registry Identifier: NCI CTRP )
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Robert Volk, PHD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP