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Trial record 78 of 482 for:    colon cancer | ( Map: Texas, United States )

Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized 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: NCT02151032
Recruitment Status : Active, not recruiting
First Posted : May 30, 2014
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to compare how people who are 45-75 years old respond to 3 different versions of a program about screening tests for colorectal cancer. Researchers want to use this study as part of a long-term project to learn the best ways to communicate health information to patients.

Condition or disease Intervention/treatment
Colorectal Cancer Behavioral: Booklet Behavioral: Audio CD Behavioral: Video with Non-Moving Images Behavioral: Video with Animated Images Behavioral: Questionnaires

Detailed Description:

If you agree to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. Neither you nor the study staff will be able to choose which group you will be in:

  • If you are in Group 1, you will read a booklet about colorectal cancer screening tests. While reading the booklet, you will also listen to an audio CD that will narrate the booklet.
  • If you are in Group 2, you will watch a video with non-moving images about colorectal cancer screening tests on an iPad.
  • If you are in Group 3, you will watch a video with animated images about colorectal cancer screening tests on an iPad.

You will complete questionnaires before and after viewing the program that will contain questions about:

  • Your age and what language you speak
  • Your math and reading comprehension
  • Your knowledge of colorectal cancer and colorectal cancer screening
  • Your thoughts about colorectal cancer screening
  • Your opinions about this study, and
  • How well you understand the booklet/video you view as part of this study

It will take about 1 hour to complete all the questionnaires. In total, the study will take about 1 ½ to 2 hours to complete. After you have completed the questionnaires, your participation in the study will be over.

This is an investigational study.

Up to 201 people will take part in this multicenter study. Up to 67 will be enrolled at MD Anderson.


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Study Type : Observational
Estimated Enrollment : 201 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
Actual Study Start Date : November 2012
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Colorectal Cancer Screening Booklet + Audio CD
Participants read the booklet about colorectal cancer screening tests, and listen to an audio CD that will narrate the booklet. Questionnaire completion before and after viewing the program.
Behavioral: Booklet
Participants read a booklet about colorectal cancer screening tests.
Other Name: Pamphlet

Behavioral: Audio CD
Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.

Behavioral: Questionnaires
Questionnaire completion before and after viewing the program.
Other Name: Surveys

Video with Non-Moving Images on iPad
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.
Behavioral: Video with Non-Moving Images
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.

Behavioral: Questionnaires
Questionnaire completion before and after viewing the program.
Other Name: Surveys

Video with Animated Images on iPad
Participants watch a video with animated images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.
Behavioral: Video with Animated Images
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.

Behavioral: Questionnaires
Questionnaire completion before and after viewing the program.
Other Name: Surveys




Primary Outcome Measures :
  1. Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program [ Time Frame: 1 day ]
    The fixed effects analysis of variance (ANOVA) will utilize a factorial design with two factors: content presentation type (standard, animated, interactive) and numeracy status (high and low based on US population scores). Main dependent measures are gist and verbatim knowledge. Gist and verbatim knowledge scores (0-100) looked at separately as well as combined.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants from MD Anderson Cancer Prevention Center (CPC), Literacy Advance of Houston (LAH), Ephiphany Community Health Outreach Services (ECHOS), and Bethel's Heavenly Hands
Criteria

Inclusion Criteria:

  1. Men and women 45 to 75 years of age.
  2. Participant must speak English.

Exclusion Criteria:

1) Self-reported diagnosis of colon cancer.


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): NCT02151032


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Bethel's Heavenly Hands
Houston, Texas, United States, 77035
Literacy Advance of Houston
Houston, Texas, United States, 77042
Ephiphany Community Health Outreach Services
Houston, Texas, United States, 77071
Sponsors and Collaborators
M.D. Anderson Cancer Center
Foundation for Informed Medical Decision Making
Investigators
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Principal Investigator: Robert Volk, PHD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02151032     History of Changes
Other Study ID Numbers: 2011-0632
0619-1 ( Other Grant/Funding Number: Foundation for Informed Medical Decision Making )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
Colorectal cancer screening
Multimedia
Booklet
Pamphlet
Audio CD
Video with animated images
Video with non-moving images
Questionnaires
Surveys
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases