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Clinical Trials/NCT01492049
NCT01492049
Completed
Not Applicable

Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

M.D. Anderson Cancer Center1 site in 1 country107 target enrollmentAugust 7, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
M.D. Anderson Cancer Center
Enrollment
107
Locations
1
Primary Endpoint
Colorectal cancer screening (CRCS) Rate of Participants
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 7, 2012
End Date
September 12, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • History of colorectal cancer
  • History of polyps
  • Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
  • Family history of colorectal cancer in a first degree relative
  • Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years

Outcomes

Primary Outcomes

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.

Study Sites (1)

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