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Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

49 Years
75 Years
Open (Enrolling)
Colorectal Neoplasms

Thank you

Trial Information

Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Colorectal cancer screening (CRCS) Rate of Participants

Outcome Description:

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.

Outcome Time Frame:

24 months for study duration

Safety Issue:


Principal Investigator

Robert Volk, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal Neoplasms
  • Promoting Health Literacy
  • Patient education program
  • Colorectal Cancer Screening
  • CRCS
  • Patient decision aid
  • PtDA
  • Video
  • Questionnaires
  • Surveys
  • Neoplasms
  • Colorectal Neoplasms



Harris County Hospital District Houston, Texas  77030