Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
July 8, 2022 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
189
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
Houston, Texas, United States, 77042
- Literacy Advance of Houston
-
Houston, Texas, United States, 77035
- Bethel's Heavenly Hands
-
Houston, Texas, United States, 77071
- Ephiphany Community Health Outreach Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
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
Description
Inclusion Criteria:
- Men and women 45 to 75 years of age.
- Participant must speak English.
Exclusion Criteria:
1) Self-reported diagnosis of colon cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
Participants read a booklet about colorectal cancer screening tests.
Other Names:
Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.
Questionnaire completion before and after viewing the program.
Other Names:
|
|
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.
|
Questionnaire completion before and after viewing the program.
Other Names:
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
|
|
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.
|
Questionnaire completion before and after viewing the program.
Other Names:
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Volk, PHD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Housten AJ, Kamath GR, Bevers TB, Cantor SB, Dixon N, Hite A, Kallen MA, Leal VB, Li L, Volk RJ. Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial. Med Decis Making. 2020 Jan;40(1):17-28. doi: 10.1177/0272989X19890296. Epub 2019 Dec 3.
- Housten AJ, Lowenstein LM, Hoover DS, Leal VB, Kamath GR, Volk RJ. Limitations of the S-TOFHLA in measuring poor numeracy: a cross-sectional study. BMC Public Health. 2018 Mar 27;18(1):405. doi: 10.1186/s12889-018-5333-9.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2012
Primary Completion (Actual)
May 19, 2020
Study Completion (Actual)
May 19, 2020
Study Registration Dates
First Submitted
May 27, 2014
First Submitted That Met QC Criteria
May 28, 2014
First Posted (Estimate)
May 30, 2014
Study Record Updates
Last Update Posted (Actual)
July 11, 2022
Last Update Submitted That Met QC Criteria
July 8, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-0632
- 0619-1 (Other Grant/Funding Number: Foundation for Informed Medical Decision Making)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.