Colorectal CancerNCT00594113
"Touch 2 Screen" Multi-media Colorectal Cancer Screening Intervention
A study testing Touch 2 Screen and Touch screen intervention in people with Colorectal Cancer, run by Allen A. Greiner, MD, MPH at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the effectiveness of a multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Touch 2 Screen and Touch screen intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be at least 50 years of age
- Must not have had a colonoscopy in the last 10 years
- Must not have completed Fecal Occult Blood Test in the past year
- Must not have a family history of colorectal cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics
The primary purpose of this study is to determine the effectiveness of a multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior. The multi-media presentation is delivered in a touch-screen computer format and contains messages about colorectal cancer that are tailored to each participant based on individual survey responses. It is hypothesized that tailored messages and defining implementation intentions may have a relationship with completion of colorectal cancer screening.
Read the detailed description
The majority of the intervention will be delivered in primary care settings on low-cost touch-screen computers through multi-media audio-narrative and video messages. Studies have not tested the effectiveness of tailored communications specified to stated "implementation intentions" for improving CRC screening. A randomized design will test a comparison of generic information versus a multi-media tailored intervention that specifically addresses each participant's screening test preference, current CRC screening decisional state (Precaution Adoption Process Model), and specified to stated "implementation intentions" (the "when," "Where," and "how" details of screening.) Behavioral intervention materials in English and Spanish will be developed with the help of cultural experts, pilot tests, and interviews that will test salience and cultural appropriateness of audio, video, and graphic messages for low-income minorities and whites. The study will be conducted with 460 patients eligible for CRC screening and recruited while presenting for care in urban clinics. All participants will receive baseline touch-screen administered assessment and, depending on stated preference, be offered either immunochemical fecal occult blood test (iFOBT-InSureTM) or a colonoscopy. Participants will be randomized to either "C" (comparison group-computer delivered generic CRC information) or "TI2" (active intervention-computer delivered tailored messaging based on individual PAPM stage, behavioral constructs, and "implementation intentions"). A brief office exit survey will assess patient-provider discussions of CRC screening and satisfaction with computerized message materials. A 90-day post randomization follow-up telephone call assessment with all participants will reassess PAPM stage and perceived CRC screening barriers.
The primary outcome will be CRC screening completion at 90 days. Secondary outcomes will assess 90-day PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy). This intervention will provide information on the utility of embedding a low-cost technologically advanced "implementation intentions" based behavioral intervention in primary care practice.
- Conditions
- Colorectal Cancer
- Being tested
- Touch 2 Screen, Touch screen intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch 2 ScreenOther
Multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior
Touch screen interventionOther
Touch screen intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multimedia Colorectal Cancer Screening Receives: Other: Touch 2 Screen; Other: Touch screen intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion
Measured: 90 Days
Secondary outcomes (1)
PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy)
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionJan 2012
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allen A. Greiner, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Allen A. Greiner, MD, MPH, University of Kansas Medical Center
- Investigators
- Allen A. Greiner, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594113
- Sponsor's protocol ID
- 1RO1CA119098-01
- Status last verified
- Jun 2012
- First submitted
- 3 Jan 2008
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Greiner KA, Geana MV, Epp A, Watson A, Filippi M, Daley CM, Engelman KK, James AS, Campbell M. A computerized intervention to promote colorectal cancer screening for underserved populations: theoretical background and algorithm development. Technol Health Care. 2012;20(1):25-35. doi: 10.3233/THC-2011-0653.
PubMed 22297711Greiner KA, Daley CM, Epp A, James A, Yeh HW, Geana M, Born W, Engelman KK, Shellhorn J, Hester CM, LeMaster J, Buckles DC, Ellerbeck EF. Implementation intentions and colorectal screening: a randomized trial in safety-net clinics. Am J Prev Med. 2014 Dec;47(6):703-14. doi: 10.1016/j.amepre.2014.08.005. Epub 2014 Nov 18.
PubMed 25455115
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics
- ClinicalTrials.gov ID
- NCT00594113
- Acronym / sponsor ID
- 1RO1CA119098-01
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Allen A. Greiner, MD, MPHUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jan 2008 (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 primary purpose of this study is to determine the effectiveness of a multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior. The multi-media presentation is delivered in a touch-screen computer format and contains messages about colorectal cancer that are tailored to each participant based on individual survey responses. It is hypothesized that tailored messages and defining implementation intentions may have a relationship with completion of colorectal cancer screening.
Detailed description
The majority of the intervention will be delivered in primary care settings on low-cost touch-screen computers through multi-media audio-narrative and video messages. Studies have not tested the effectiveness of tailored communications specified to stated "implementation intentions" for improving CRC screening. A randomized design will test a comparison of generic information versus a multi-media tailored intervention that specifically addresses each participant's screening test preference, current CRC screening decisional state (Precaution Adoption Process Model), and specified to stated "implementation intentions" (the "when," "Where," and "how" details of screening.) Behavioral intervention materials in English and Spanish will be developed with the help of cultural experts, pilot tests, and interviews that will test salience and cultural appropriateness of audio, video, and graphic messages for low-income minorities and whites. The study will be conducted with 460 patients eligible for CRC screening and recruited while presenting for care in urban clinics. All participants will receive baseline touch-screen administered assessment and, depending on stated preference, be offered either immunochemical fecal occult blood test (iFOBT-InSureTM) or a colonoscopy. Participants will be randomized to either "C" (comparison group-computer delivered generic CRC information) or "TI2" (active intervention-computer delivered tailored messaging based on individual PAPM stage, behavioral constructs, and "implementation intentions"). A brief office exit survey will assess patient-provider discussions of CRC screening and satisfaction with computerized message materials. A 90-day post randomization follow-up telephone call assessment with all participants will reassess PAPM stage and perceived CRC screening barriers.
The primary outcome will be CRC screening completion at 90 days. Secondary outcomes will assess 90-day PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy). This intervention will provide information on the utility of embedding a low-cost technologically advanced "implementation intentions" based behavioral intervention in primary care practice.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Touch 2 Screen, Other: Touch screen interventionMultimedia Colorectal Cancer Screening |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be at least 50 years of age
- Must not have had a colonoscopy in the last 10 years
- Must not have completed Fecal Occult Blood Test in the past year
- Must not have a family history of colorectal cancer.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Touch 2 ScreenMulti-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior | Other | 1 |
| Touch screen interventionTouch screen intervention | Other | 1 |
Primary outcome
CRC screening completion
Time frame: 90 Days
1 secondary outcome
PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy)
Time frame: 90 Days
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 20 Jun 2012.
- Background: PubMed 22297711Greiner KA, Geana MV, Epp A, Watson A, Filippi M, Daley CM, Engelman KK, James AS, Campbell M. A computerized intervention to promote colorectal cancer screening for underserved populations: theoretical background and algorithm development. Technol Health Care. 2012;20(1):25-35. doi: 10.3233/THC-2011-0653.
- Derived from this study: PubMed 25455115Greiner KA, Daley CM, Epp A, James A, Yeh HW, Geana M, Born W, Engelman KK, Shellhorn J, Hester CM, LeMaster J, Buckles DC, Ellerbeck EF. Implementation intentions and colorectal screening: a randomized trial in safety-net clinics. Am J Prev Med. 2014 Dec;47(6):703-14. doi: 10.1016/j.amepre.2014.08.005. Epub 2014 Nov 18.
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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.
Allen A. Greiner, MD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch 2 Screen and Touch screen intervention in people with Colorectal Cancer, run by Allen A. Greiner, MD, MPH at 1 site 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 4 inclusion and 0 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 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
CRC screening completion (time frame: 90 Days). 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 NCT00594113, 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 20 Jun 2012.