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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151032
• Other study ID #: 2011-0632
• Secondary ID: 0619-1
• Status: Completed
• Start date: November 2012
• Est. completion date: May 19, 2020

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Booklet
Participants read a booklet about colorectal cancer screening tests.
• Audio CD
Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.
• Video with Non-Moving Images
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
• Video with Animated Images
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
• Questionnaires
Questionnaire completion before and after viewing the program.

Locations

Country	Name	City	State
United States	Bethel's Heavenly Hands	Houston	Texas
United States	Ephiphany Community Health Outreach Services	Houston	Texas
United States	Literacy Advance of Houston	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Foundation for Informed Medical Decision Making

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program	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

External Links

•   University of Texas MD Anderson Cancer Center Website