Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial

NCT ID: NCT02151032

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-05-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Booklet

Intervention Type BEHAVIORAL

Participants read a booklet about colorectal cancer screening tests.

Audio CD

Intervention Type BEHAVIORAL

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

Questionnaires

Intervention Type BEHAVIORAL

Questionnaire completion before and after viewing the program.

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.

Video with Non-Moving Images

Intervention Type BEHAVIORAL

Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.

Questionnaires

Intervention Type BEHAVIORAL

Questionnaire completion before and after viewing the program.

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.

Video with Animated Images

Intervention Type BEHAVIORAL

Participants watch a video with animated images about colorectal cancer screening tests on an iPad.

Questionnaires

Intervention Type BEHAVIORAL

Questionnaire completion before and after viewing the program.

Interventions

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Booklet

Participants read a booklet about colorectal cancer screening tests.

Intervention Type BEHAVIORAL

Audio CD

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

Intervention Type BEHAVIORAL

Video with Non-Moving Images

Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.

Intervention Type BEHAVIORAL

Video with Animated Images

Participants watch a video with animated images about colorectal cancer screening tests on an iPad.

Intervention Type BEHAVIORAL

Questionnaires

Questionnaire completion before and after viewing the program.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pamphlet Surveys

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Informed Medical Decision Making

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Volk, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Bethel's Heavenly Hands

Houston, Texas, United States

Site Status

Literacy Advance of Houston

Houston, Texas, United States

Site Status

Ephiphany Community Health Outreach Services

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31795820 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29587709 (View on PubMed)

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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0619-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-0632

Identifier Type: -

Identifier Source: org_study_id

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