Colorectal CancerNCT00593073
Use of Novel Tailored Reminders in Rural Primary Care
A study testing Electronic tailored messaging and General Reminder Message in people with Colorectal Cancer, run by University of Kansas at 1 site in United States.
Trial summary
Effective programs are needed that can overcome barriers to CRC screening among persons in rural communities. There is good evidence to suggest that a program employing patient activation and tailoring to address the specific concerns of individuals will be an effective model for addressing CRC screening… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Electronic tailored messaging and General Reminder Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- at average risk for colorectal cancer
- not up to date with colorectal cancer screening
Who cannot join
- Younger than 50 years of age
- at high risk for colorectal cancer
- up to date with colorectal cancer screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Effective programs are needed that can overcome barriers to CRC screening among persons in rural communities. There is good evidence to suggest that a program employing patient activation and tailoring to address the specific concerns of individuals will be an effective model for addressing CRC screening underutilization for rural residents. In this study, we propose to test such a model among rural primary care patients, a group that has, to date, received little attention. We will also bolster how tailored messaging is traditionally conducted by using a tailored informational flyer format that uses physicians as the message source to increase message saliency. This study will help to assess how a relatively low-cost, disseminable technology can effectively circumvent the "systems problems" endemic in rural primary care. This project will lay the groundwork in practice based research network clinics for future intervention studies which operationalize office and community-based technology to help rural primary care patients make informed health decisions and engage in healthy lifestyle behaviors.
Read the detailed description
Screening for colorectal cancer (CRC) remains severely underutilized. Although simple reminders are modestly effective in enhancing preventive care utilization, they are not widely utilized. Even if used widely, the effectiveness of simple reminders is limited, leaving nearly half of patients without screening. One explanation for this is that simple reminders do not address the barriers and resources of the patients and physicians they are designed to prompt. In this study, we will examine the impact on CRC screening of a reminder system that uses the physician as the message source and is tailored to the physician screening preferences and patient-reported characteristics, CRC screening-related barriers, status and CRC susceptibility. This intervention will be compared to a standard CRC health education and screening reminder system.
Touch screen 'Healthy Living' computer kiosks will be placed in 16 Kansas Physicians Engaged in Prevention Research (KPEPR) Network primary care practices. The kiosk program will screen for eligible participants who are at least 50 years of age and not up-to-date with CRC screening and guide eligible participants through a computerized Colorectal Cancer Assessment (CRCA). Kiosk participants will be randomized into either a general CRC health education + screening reminder message (GRM) (N=640) or a patient and physician-tailored CRC + screening reminder message (TRM) (N=640). Immediately upon completion of the CRCA, GRM participants will receive a brief informational flyer with general CRC health education messages and a reminder to get screened routinely for CRC. Participants in the TRM arm will receive an informational flyer that contains messages that are tailored to patient CRC screening barriers, preferences, and attitudes and physician screening preferences (guided by CRC screening options that are available within the local community) in addition to a reminder to get screened for CRC. A 90-day telephone follow-up will assess participant compliance with CRC screening recommendations, participant discussion with their physician regarding CRC screening, and patient satisfaction.
This study will use a novel patient- and physician- tailored messaging approach to promote colorectal cancer screening utilization. This study will help to assess how a practice-based computerized patient activation approach can effectively circumvent the "systems problems" endemic in rural primary care and lay the groundwork for future computer-based primary care intervention studies to help patients make informed health decisions and engage in healthy lifestyle behaviors.
- Conditions
- Colorectal Cancer
- Being tested
- Electronic tailored messaging, General Reminder Message
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic tailored messagingBehavioural
Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.
General Reminder MessageBehavioural
General CRC health education message and reminder to get screened.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tailored Reminder Message Receives: Behavioral: Electronic tailored messaging |
| 2 | Experimental | General Reminder Message Receives: Behavioral: General Reminder Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.
Measured: Baseline, 90 Days
Secondary outcomes (1)
Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening
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 posted14 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kimberly K. Engelman, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593073
- Sponsor's protocol ID
- 10174
- Other IDs
- 1R21CA121907-01
- Status last verified
- Sep 2008
- First submitted
- 31 Dec 2007
- Last updated
- 12 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel Tailored Reminders in Rural Primary Care
- ClinicalTrials.gov ID
- NCT00593073
- Acronym / sponsor ID
- 10174
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 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.
Effective programs are needed that can overcome barriers to CRC screening among persons in rural communities. There is good evidence to suggest that a program employing patient activation and tailoring to address the specific concerns of individuals will be an effective model for addressing CRC screening underutilization for rural residents. In this study, we propose to test such a model among rural primary care patients, a group that has, to date, received little attention. We will also bolster how tailored messaging is traditionally conducted by using a tailored informational flyer format that uses physicians as the message source to increase message saliency. This study will help to assess how a relatively low-cost, disseminable technology can effectively circumvent the "systems problems" endemic in rural primary care. This project will lay the groundwork in practice based research network clinics for future intervention studies which operationalize office and community-based technology to help rural primary care patients make informed health decisions and engage in healthy lifestyle behaviors.
Detailed description
Screening for colorectal cancer (CRC) remains severely underutilized. Although simple reminders are modestly effective in enhancing preventive care utilization, they are not widely utilized. Even if used widely, the effectiveness of simple reminders is limited, leaving nearly half of patients without screening. One explanation for this is that simple reminders do not address the barriers and resources of the patients and physicians they are designed to prompt. In this study, we will examine the impact on CRC screening of a reminder system that uses the physician as the message source and is tailored to the physician screening preferences and patient-reported characteristics, CRC screening-related barriers, status and CRC susceptibility. This intervention will be compared to a standard CRC health education and screening reminder system.
Touch screen 'Healthy Living' computer kiosks will be placed in 16 Kansas Physicians Engaged in Prevention Research (KPEPR) Network primary care practices. The kiosk program will screen for eligible participants who are at least 50 years of age and not up-to-date with CRC screening and guide eligible participants through a computerized Colorectal Cancer Assessment (CRCA). Kiosk participants will be randomized into either a general CRC health education + screening reminder message (GRM) (N=640) or a patient and physician-tailored CRC + screening reminder message (TRM) (N=640). Immediately upon completion of the CRCA, GRM participants will receive a brief informational flyer with general CRC health education messages and a reminder to get screened routinely for CRC. Participants in the TRM arm will receive an informational flyer that contains messages that are tailored to patient CRC screening barriers, preferences, and attitudes and physician screening preferences (guided by CRC screening options that are available within the local community) in addition to a reminder to get screened for CRC. A 90-day telephone follow-up will assess participant compliance with CRC screening recommendations, participant discussion with their physician regarding CRC screening, and patient satisfaction.
This study will use a novel patient- and physician- tailored messaging approach to promote colorectal cancer screening utilization. This study will help to assess how a practice-based computerized patient activation approach can effectively circumvent the "systems problems" endemic in rural primary care and lay the groundwork for future computer-based primary care intervention studies to help patients make informed health decisions and engage in healthy lifestyle behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Electronic tailored messagingTailored Reminder Message |
| 2 | Experimental | Behavioral: General Reminder MessageGeneral Reminder Message |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years of age or older
- at average risk for colorectal cancer
- not up to date with colorectal cancer screening
Key exclusion criteria (3 listed)
- Younger than 50 years of age
- at high risk for colorectal cancer
- up to date with colorectal cancer screening
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 |
|---|---|---|
| Electronic tailored messagingTailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened. | Behavioural | 1 |
| General Reminder MessageGeneral CRC health education message and reminder to get screened. | Behavioural | 2 |
Primary outcome
Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.
Time frame: Baseline, 90 Days
1 secondary outcome
Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening
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 12 Sep 2008.
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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.
Kimberly K. Engelman, PhD 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 Electronic tailored messaging and General Reminder Message in people with Colorectal Cancer, run by University of Kansas 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 3 inclusion and 3 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 12 Sep 2008. 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?
Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey. (time frame: Baseline, 90 Days). 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 12 Sep 2008.