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Completed

NCT Number: NCT01492049

R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

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

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

49 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harris County Hospital District

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRCS patient decision aid (PtDA) video

Behavioral

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

Questionnaires

Behavioral

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

Other names: survey

Essential Hypertension video

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2011
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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