Clinical trial NCT01492049: R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Official title: Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms
Promoting Health Literacy
Patient education program
Colorectal Cancer Screening
CRCS
Patient decision aid
PtDA
Video
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-14
Enrollment: 107
Sex: ALL
Minimum age (years): 49
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colorectal cancer screening (CRCS) Rate of Participants
timeFrame: 24 months for study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris County Hospital District
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: PRINCIPAL_INVESTIGATOR
References: