Colorectal CancerNCT02151032
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Booklet, Audio CD and Video with Non-Moving Images
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 189 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to 19 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Men and women 45 to 75 years of age.
- Participant must speak English.
Who cannot join
- 1) Self-reported diagnosis of colon cancer.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Bethel's Heavenly Hands
Houston, Texas, 77035
Literacy Advance of Houston
Houston, Texas, 77042
Ephiphany Community Health Outreach Services
Houston, Texas, 77071
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Booklet, Audio CD, Video with Non-Moving Images, Video with Animated Images, Questionnaires
- Keywords
- Colorectal Cancer, Colorectal cancer screening, Multimedia, Booklet, Pamphlet, Audio CD, Video with animated images, Video with non-moving images, Questionnaires, Surveys
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BookletBehavioural
Also called Pamphlet
Participants read a booklet about colorectal cancer screening tests.
Audio CDBehavioural
Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.
Video with Non-Moving ImagesBehavioural
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
Video with Animated ImagesBehavioural
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion before and after viewing the program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Booklet; Behavioral: Audio CD; Behavioral: 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. Receives: Behavioral: Video with Non-Moving Images; Behavioral: 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. Receives: Behavioral: Video with Animated Images; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startNov 2012
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Responsible party
- Sponsor
- Investigators
- Robert Volk, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151032
- Sponsor's protocol ID
- 2011-0632
- Other IDs
- 0619-1
- Status last verified
- Nov 2023
- First submitted
- 27 May 2014
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31795820Housten 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.
PubMed 29587709
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
- ClinicalTrials.gov ID
- NCT02151032
- Acronym / sponsor ID
- 2011-0632
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Colorectal cancer screening, Multimedia, Booklet, Pamphlet, Audio CD, Video with animated images, Video with non-moving images
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Study start
- Nov 2012 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Screening Booklet + Audio CD | – | Behavioral: Booklet, Behavioral: Audio CD, Behavioral: QuestionnairesParticipants 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. |
| Video with Non-Moving Images on iPad | – | Behavioral: Video with Non-Moving Images, Behavioral: QuestionnairesParticipants 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 Animated Images on iPad | – | Behavioral: Video with Animated Images, Behavioral: QuestionnairesParticipants watch a video with animated images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Men and women 45 to 75 years of age.
- Participant must speak English.
Key exclusion criteria (1 listed)
- 1) Self-reported diagnosis of colon cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BookletAlso: PamphletParticipants read a booklet about colorectal cancer screening tests. | Behavioural | Colorectal Cancer Screening Booklet + Audio CD |
| Audio CDParticipants listen to an audio CD that will narrate the colorectal cancer screening tests booklet. | Behavioural | Colorectal Cancer Screening Booklet + Audio CD |
| Video with Non-Moving ImagesParticipants watch a video with non-moving images about colorectal cancer screening tests on an iPad. | Behavioural | Video with Non-Moving Images on iPad |
| Video with Animated ImagesParticipants watch a video with animated images about colorectal cancer screening tests on an iPad. | Behavioural | Video with Animated Images on iPad |
| QuestionnairesAlso: SurveysQuestionnaire completion before and after viewing the program. | Behavioural | Colorectal Cancer Screening Booklet + Audio CD, Video with Animated Images on iPad, Video with Non-Moving Images on iPad |
Primary outcome
Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 31795820Housten 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.
- Derived from this study: PubMed 29587709Housten 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Volk, PHD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.