Skip to content

R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01492049
Enrollment
107
Registered
2011-12-14
Start date
2012-08-07
Completion date
2018-09-12
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

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

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.

Interventions

BEHAVIORALCRCS patient decision aid (PtDA) video

Participant views PtDA program video in same room as research assistant who offers instruction as needed.

BEHAVIORALQuestionnaires

Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.

BEHAVIORALEssential Hypertension video

Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
49 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal cancer screening (CRCS) Rate of Participants24 months for study durationCRCS 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026