Colorectal CancerPhase 3NCT01072851
Tools for Improving Colorectal Cancer Screening Rates: Multimedia Versus Print
A Phase 3 study testing Multimedia Education, Print Media and Usual and customary waiting room process in people with Colorectal Cancer, run by Trinity Health Of New England at 3 sites in United States.
Trial summary
The objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Multimedia Education, Print Media and Usual and customary waiting room process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Sep 2012
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-80 years of age,
- Registered for an appointment at one of the target clinics,
- Speaks English or Spanish.
Who cannot join
- Patient has had CRC screening in the past 12 months,
- Unable to review the study materials because of language, physical condition or literacy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midlakes Medical Building
Highland Park, Illinois, 60085
North Chicago Health Center
North Chicago, Illinois, 60064
Belvidere Medical Building
Waukegan, Illinois, 60085
About this study
Official title: Tools for Improving Colorectal Cancer Screening Rates: Multimedia vs Print
The objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel content to allow valid comparison of format-related effects on knowledge and screening rates.These easy to use tools will provide under served patients at community health centers with clear and consistent messages about colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a doctor.
Specific Aims
- To determine if multimedia and print interventions that provide patients with information and motivational messages about CRC screening increase screening rates above usual care.
- Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.
- Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.
- Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity
- Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.
Read the detailed description
Despite the clear benefits of screening for early detection and prevention of colorectal cancer, as many as half of eligible adults remain unscreened. Poor and under served populations, particularly African American and Latino/Hispanic adults, are at greatest risk for noncompliance with recommended tests. Health education strategies developed to date have led to relatively minimal gains, resulting in little translation to routine clinical practice. This is especially true in more difficult, resource-strained practice settings, such as community health centers.
The interventions in the proposed study draw on communication science to optimize message design, use communication technology to optimize message delivery and include parallel content in both print and multimedia versions to allow comparison of format-related effects on both knowledge and screening rates.The multimedia and print tools are based on patient education programs that we developed with extensive attention to theory as well as community member input.
- Conditions
- Colorectal Cancer
- Being tested
- Multimedia Education, Print Media, Usual and customary waiting room process
- Keywords
- colorectal cancer screening, multimedia education, print education, culturally competent
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia EducationBehavioural
Also called colon cancer, communication, patient education
A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
Print MediaBehavioural
Also called colon cancer, communication, education
Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
Usual and customary waiting room processBehavioural
Also called colon cancer, communitcation, education
No specialized educational intervention to promote colorectal cancer screening or to explain the process
| Study group | Role | What they receive |
|---|---|---|
| Multimedia educational tool | Experimental | Multimedia education tool - A culturally competent video explaining the importance of and the process of colorectal cancer screening Receives: Behavioral: Multimedia Education |
| Print educational tool | Experimental | Print media - A culturally competent printed brochure explaining the importance of and the process of colorectal cancer screening Receives: Behavioral: Print Media |
| No intervention | Active comparator | Usual and customary waiting room process - Usual and customary office waiting period with access to standard nationally generated colorectal cancer screening informational material in the waiting room and/or exam room. Receives: Behavioral: Usual and customary waiting room process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools
Measured: 3 months post visit
Secondary outcomes (2)
Role of race/ethnicity and literacy levels on the comparative effects if the intervention
Measured: At scheduled appointment
Comparative knowledge of colorectal cancer screening by patients who view the print or multi-media educational tools.
Measured: At the scheduled patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Northwestern University
- Responsible party
- Sponsor
- Investigators
- Gregory Makoul, PHD, Principal investigator, St. Francis Hospital & Medical Center, Hartford CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072851
- Sponsor's protocol ID
- 0910001-E
- Status last verified
- Sep 2012
- First submitted
- 18 Feb 2010
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools for Improving Colorectal Cancer Screening Rates: Multimedia vs Print
- ClinicalTrials.gov ID
- NCT01072851
- Acronym / sponsor ID
- 0910001-E
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer screening, multimedia education, print education, culturally competent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Northwestern University
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Feb 2010 (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 objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel content to allow valid comparison of format-related effects on knowledge and screening rates.These easy to use tools will provide under served patients at community health centers with clear and consistent messages about colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a doctor.
Specific Aims
- To determine if multimedia and print interventions that provide patients with information and motivational messages about CRC screening increase screening rates above usual care.
- Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.
- Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.
- Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity
- Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.
Detailed description
Despite the clear benefits of screening for early detection and prevention of colorectal cancer, as many as half of eligible adults remain unscreened. Poor and under served populations, particularly African American and Latino/Hispanic adults, are at greatest risk for noncompliance with recommended tests. Health education strategies developed to date have led to relatively minimal gains, resulting in little translation to routine clinical practice. This is especially true in more difficult, resource-strained practice settings, such as community health centers.
The interventions in the proposed study draw on communication science to optimize message design, use communication technology to optimize message delivery and include parallel content in both print and multimedia versions to allow comparison of format-related effects on both knowledge and screening rates.The multimedia and print tools are based on patient education programs that we developed with extensive attention to theory as well as community member input.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multimedia educational tool | Experimental | Behavioral: Multimedia EducationMultimedia education tool - A culturally competent video explaining the importance of and the process of colorectal cancer screening |
| Print educational tool | Experimental | Behavioral: Print MediaPrint media - A culturally competent printed brochure explaining the importance of and the process of colorectal cancer screening |
| No intervention | Active comparator | Behavioral: Usual and customary waiting room processUsual and customary waiting room process - Usual and customary office waiting period with access to standard nationally generated colorectal cancer screening informational material in the waiting room and/or exam room. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-80 years of age,
- Registered for an appointment at one of the target clinics,
- Speaks English or Spanish.
Key exclusion criteria (2 listed)
- Patient has had CRC screening in the past 12 months,
- Unable to review the study materials because of language, physical condition or literacy.
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 |
|---|---|---|
| Multimedia EducationAlso: colon cancer, communication, patient educationA four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures. | Behavioural | Multimedia educational tool |
| Print MediaAlso: colon cancer, communication, educationExposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures. | Behavioural | Print educational tool |
| Usual and customary waiting room processAlso: colon cancer, communitcation, educationNo specialized educational intervention to promote colorectal cancer screening or to explain the process | Behavioural | No intervention |
Primary outcome
Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools
Time frame: 3 months post visit
2 secondary outcomes
Role of race/ethnicity and literacy levels on the comparative effects if the intervention
Time frame: At scheduled appointment
Comparative knowledge of colorectal cancer screening by patients who view the print or multi-media educational tools.
Time frame: At the scheduled patient visit
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 7 Sep 2012.
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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.
Gregory Makoul, PHD principal investigator
St. Francis Hospital & Medical Center, Hartford CT
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multimedia Education, Print Media and Usual and customary waiting room process in people with Colorectal Cancer, run by Trinity Health Of New England at 3 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 3 inclusion and 2 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 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools (time frame: 3 months post visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2012.