Clinical trial NCT02151032: Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
Official title: Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Colorectal cancer screening
Multimedia
Booklet
Pamphlet
Audio CD
Video with animated images
Video with non-moving images
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2014-05-30
Enrollment: 189
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Bethel's Heavenly Hands
state: Texas
city: Houston
country: United States
facility: Literacy Advance of Houston
state: Texas
city: Houston
country: United States
facility: Ephiphany Community Health Outreach Services
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.