Trial record 8 of 27 for:    Open Studies | "Health Literacy"

R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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: March 24, 2014
Last verified: March 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Trial - Promoting Health Literacy for Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   49 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492049

Contacts
Contact: Robert Volk, PHD 713-745-4516

Locations
United States, Texas
Harris County Hospital District Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Robert Volk, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01492049     History of Changes
Other Study ID Numbers: 2010-0698, R21CA132669
Study First Received: December 12, 2011
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014