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

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: Colorectal Cancer
• Intervention / Treatment: Behavioral: Booklet; Behavioral: Audio CD; Behavioral: Questionnaires; Behavioral: Video with Non-Moving Images; Behavioral: Video with Animated Images

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

Study Locations

• United States
  • 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

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:

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

Exclusion Criteria:

1) Self-reported diagnosis of colon cancer.

Study Plan

How is the study designed?

Number of groups / cohorts

3

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.	Behavioral: Booklet; Participants read a booklet about colorectal cancer screening tests.; Other Names: 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 Names: 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: Questionnaires; Questionnaire completion before and after viewing the program.; Other Names: Surveys; Behavioral: 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 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: Questionnaires; Questionnaire completion before and after viewing the program.; Other Names: Surveys; Behavioral: Video with Animated Images; 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	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

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Foundation for Informed Medical Decision Making
• Investigators: Principal Investigator: Robert Volk, PHD, M.D. Anderson Cancer Center

Publications and helpful links

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

• University of Texas MD Anderson Cancer Center Website

Study record dates

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: Colorectal Cancer; Colorectal cancer screening; Questionnaires; Surveys; Pamphlet; Multimedia; Booklet; Audio CD; Video with animated images; Video with non-moving images
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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