R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01492049
First received: December 12, 2011
Last updated: September 24, 2014
Last verified: September 2014

December 12, 2011
September 24, 2014
August 2012
August 2016   (final data collection date for primary outcome measure)
Colorectal cancer screening (CRCS) Rate of Participants [ Time Frame: 24 months for study duration ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01492049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Colorectal Neoplasms
  • 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
  • Behavioral: Essential Hypertension video
    Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
  • Experimental: Patient Decision Aid (PtDA)
    Participants view Patient decision aid (PtDA) video.
    Interventions:
    • Behavioral: CRCS patient decision aid (PtDA) video
    • Behavioral: Questionnaires
  • Active Comparator: Control
    Participants view a video on Essential Hypertension.
    Interventions:
    • Behavioral: Questionnaires
    • Behavioral: Essential Hypertension video
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
Not Provided
August 2016   (final data collection date for primary outcome measure)

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
Both
49 Years to 75 Years
Yes
Contact: Robert Volk, PHD 713-745-4516
United States
 
NCT01492049
2010-0698, R21CA132669
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Robert Volk, PHD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP