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R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01492049
Recruitment Status : Active, not recruiting
First Posted : December 14, 2011
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Behavioral: CRCS patient decision aid (PtDA) video Behavioral: Questionnaires Behavioral: Essential Hypertension video

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
Actual Study Start Date : August 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Patient Decision Aid (PtDA)
Participants view Patient decision aid (PtDA) video.
Behavioral: CRCS patient decision aid (PtDA) video
Participant views PtDA program video in same room as research assistant who offers instruction as needed.
Behavioral: Questionnaires
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Other Name: survey
Active Comparator: Control
Participants view a video on Essential Hypertension.
Behavioral: Questionnaires
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Other Name: survey
Behavioral: Essential Hypertension video
Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492049


Locations
United States, Texas
Harris County Hospital District
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert Volk, PHD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01492049     History of Changes
Other Study ID Numbers: 2010-0698
R21CA132669 ( U.S. NIH Grant/Contract )
NCI-2015-01899 ( Registry Identifier: NCI CTRP )
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Neoplasms
Promoting Health Literacy
Patient education program
Colorectal Cancer Screening
CRCS
Patient decision aid
PtDA
Video
Questionnaires
Surveys

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases