NCT02151032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7.6 years

First QC Date

May 27, 2014

Last Update Submit

November 9, 2023

Conditions

Keywords

Colorectal CancerColorectal cancer screeningMultimediaBookletPamphletAudio CDVideo with animated imagesVideo with non-moving imagesQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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: BookletBehavioral: Audio CDBehavioral: Questionnaires

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: Video with Non-Moving ImagesBehavioral: Questionnaires

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: Video with Animated ImagesBehavioral: Questionnaires

Interventions

BookletBEHAVIORAL

Participants read a booklet about colorectal cancer screening tests.

Also known as: Pamphlet
Colorectal Cancer Screening Booklet + Audio CD
Audio CDBEHAVIORAL

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

Colorectal Cancer Screening Booklet + Audio CD

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

Video with Non-Moving Images on iPad

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

Video with Animated Images on iPad
QuestionnairesBEHAVIORAL

Questionnaire completion before and after viewing the program.

Also known as: Surveys
Colorectal Cancer Screening Booklet + Audio CDVideo with Animated Images on iPadVideo with Non-Moving Images on iPad

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • \) Self-reported diagnosis of colon cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Bethel's Heavenly Hands

Houston, Texas, 77035, United States

Location

Literacy Advance of Houston

Houston, Texas, 77042, United States

Location

Ephiphany Community Health Outreach Services

Houston, Texas, 77071, United States

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Videotape RecordingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Volk, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 30, 2014

Study Start

November 1, 2012

Primary Completion

May 19, 2020

Study Completion

May 19, 2020

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations