R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRCS patient decision aid (PtDA) video
Questionnaires
Essential Hypertension video
Sponsored by
About this trial
This is an interventional other trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Promoting Health Literacy, Patient education program, Colorectal Cancer Screening, CRCS, Patient decision aid, PtDA, Video, Questionnaires, Surveys
Eligibility Criteria
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
Sites / Locations
- Harris County Hospital District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient Decision Aid (PtDA)
Control
Arm Description
Participants view Patient decision aid (PtDA) video.
Participants view a video on Essential Hypertension.
Outcomes
Primary Outcome Measures
Colorectal cancer screening (CRCS) Rate of Participants
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01492049
First Posted
December 12, 2011
Last Updated
November 16, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01492049
Brief Title
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Official Title
Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2012 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Neoplasms, Promoting Health Literacy, Patient education program, Colorectal Cancer Screening, CRCS, Patient decision aid, PtDA, Video, Questionnaires, Surveys
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Decision Aid (PtDA)
Arm Type
Experimental
Arm Description
Participants view Patient decision aid (PtDA) video.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants view a video on Essential Hypertension.
Intervention Type
Behavioral
Intervention Name(s)
CRCS patient decision aid (PtDA) video
Intervention Description
Participant views PtDA program video in same room as research assistant who offers instruction as needed.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
survey
Intervention Description
Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
Intervention Type
Behavioral
Intervention Name(s)
Essential Hypertension video
Intervention Description
Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
Primary Outcome Measure Information:
Title
Colorectal cancer screening (CRCS) Rate of Participants
Description
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.
Time Frame
24 months for study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Volk, PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harris County Hospital District
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
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