Colorectal CancerNCT00955188
Computer-Based Tailored or Standard Information for Colorectal Cancer Screening
An observational study of Colorectal Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- computer-assisted intervention, educational intervention and medical chart review
- How many people
- 345 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2004to May 2008
- 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 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Kelsey-Seybold Clinic, Houston, Tx Study Coordinator: Bettencourt , Judy ( ) Email: Judith.L.Bettencourt@uth.tmc.e Phone: 713-500-9754
DISEASE CHARACTERISTICS:
- At average risk for colorectal cancer (CRC), defined as the following:
- No personal history of CRC, adenomatous colon polyps, or inflammatory bowel disease
- No family history of CRC
- Not up-to-date with CRC screening in past year OR have never been screened, defined as
- Up-to-date screening is defined as having completed 1 of the following:
- Fecal occult blood test within the past 2 years
- Sigmoidoscopy within the past 5 years
- Colonoscopy with the past 10 years
- Double-contrast barium enema within the past 5 years
- Patient at San Francisco Community Health Network or at Henry Ford Health System and a member of the Health Alliance Plan
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 1 year
- No history of inflammatory bowel disease, polyposis, or hereditary nonpolyposis
- No severe comorbidity or significantly lowered life expectancy, including any of the following:
- Do not resuscitate (DNR)/do not intubate (DNI) code status
- Metastatic cancer
- End-stage congestive heart failure
- Severe chronic obstructive pulmonary disease
- Coronary artery disease with recent myocardial infarction or unstable angina
- Dementia
PRIOR CONCURRENT THERAPY:
- No prior bowel resection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Evaluating a Preference-tailored Intervention to Increase CRC Screening in Primary Care Settings
RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings.
PURPOSE: This randomized clinical trial is studying computer-based tailored information to see how well it works compared with standard information for colorectal cancer screening.
Read the detailed description
OBJECTIVES:
- To evaluate the effectiveness of a preference-tailored (PT) intervention vs standard information (SI) delivered via computer for increasing patients' adherence to colorectal cancer (CRC)-screening guidelines in a randomized controlled trial in two racially/ethnically diverse geographic locations.
- To assess the impact of the intervention on patient perceptions of informed-decision making, physician recommendation for CRC screening, decision conflict and satisfaction, and intention to get screened 3 days after a primary care visit.
- To conduct a cost-effectiveness analysis of a preference-tailored strategy for increasing CRC screening utilization.
OUTLINE: This is a multicenter study. Patients are randomized by the computer program to 1 of 3 intervention arms.
- Arm I (preference-tailored intervention): Patients receive overview information about colorectal cancer (CRC), including graphics and descriptions of the colon and colon polyps. Patients then complete a preference-assessment exercise test by using a specially designed website. A brief description of the test is given at this time, and patients are offered the option to learn more about their preference-matched test. Patients are then given a list of other available CRC-screening tests with a brief description and option to learn more about each test. The program informs them when all information has been viewed. At the time the patients exit the program, or have viewed all the information available, they are asked to choose which test is preferable to receive from a list of existing test options.
- Arm II (standard information intervention): Patients receive overview information as in arm I. The patients then use a website listing of the four existing CRC screening test options along with graphical representations. They are allowed to interact with this web page to view basic or more information about any or all of the tests. The program informs them when all the information has been viewed. At this point, patients are asked to choose which test they would prefer to receive from a list of existing test options, as in arm I.
- Arm III (usual care): Patients receive usual care and do not receive any extra educational materials. Patients may receive a telephone follow up at 12 months.
Upon completion of the intervention, patients in arms I and II receive a printout to take with them to their upcoming appointment. For those in arm I, this printout will include their top three attributes, their preference-matched test, and their final test choice. For those in arm II, this printout will include a list of the four screening tests but will not list their final test choice.
Patients in arm I and II undergo a 3-day follow-up telephone interview. Medical charts of all patients in all 3 arms are reviewed at 12 months.
- Conditions
- Colorectal Cancer
- Being tested
- computer-assisted intervention, educational intervention, medical chart review
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted interventionOther
educational interventionOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to colorectal cancer screening at 12 months post-intervention
Measured: 12 months
Secondary outcomes (4)
Elements of informed decision making
Measured: 12 months
Knowledge about screening options
Measured: 12 months
Decisional conflict and satisfaction
Measured: 12 months
Intention to get screened
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startAug 2004
- Primary completionApr 2007
- Study completionMay 2008
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.
- More trials run by University of Michigan Rogel 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 only
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah T. Hawley, PhD, MPH, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955188
- Sponsor's protocol ID
- CDR0000632080
- Other IDs
- R01CA131041, P30CA046592, H8000-32900-01
- Status last verified
- Dec 2012
- First submitted
- 7 Aug 2009
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Preference-tailored Intervention to Increase CRC Screening in Primary Care Settings
- ClinicalTrials.gov ID
- NCT00955188
- Acronym / sponsor ID
- CDR0000632080
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Aug 2009 (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.
RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings.
PURPOSE: This randomized clinical trial is studying computer-based tailored information to see how well it works compared with standard information for colorectal cancer screening.
Detailed description
OBJECTIVES:
- To evaluate the effectiveness of a preference-tailored (PT) intervention vs standard information (SI) delivered via computer for increasing patients' adherence to colorectal cancer (CRC)-screening guidelines in a randomized controlled trial in two racially/ethnically diverse geographic locations.
- To assess the impact of the intervention on patient perceptions of informed-decision making, physician recommendation for CRC screening, decision conflict and satisfaction, and intention to get screened 3 days after a primary care visit.
- To conduct a cost-effectiveness analysis of a preference-tailored strategy for increasing CRC screening utilization.
OUTLINE: This is a multicenter study. Patients are randomized by the computer program to 1 of 3 intervention arms.
- Arm I (preference-tailored intervention): Patients receive overview information about colorectal cancer (CRC), including graphics and descriptions of the colon and colon polyps. Patients then complete a preference-assessment exercise test by using a specially designed website. A brief description of the test is given at this time, and patients are offered the option to learn more about their preference-matched test. Patients are then given a list of other available CRC-screening tests with a brief description and option to learn more about each test. The program informs them when all information has been viewed. At the time the patients exit the program, or have viewed all the information available, they are asked to choose which test is preferable to receive from a list of existing test options.
- Arm II (standard information intervention): Patients receive overview information as in arm I. The patients then use a website listing of the four existing CRC screening test options along with graphical representations. They are allowed to interact with this web page to view basic or more information about any or all of the tests. The program informs them when all the information has been viewed. At this point, patients are asked to choose which test they would prefer to receive from a list of existing test options, as in arm I.
- Arm III (usual care): Patients receive usual care and do not receive any extra educational materials. Patients may receive a telephone follow up at 12 months.
Upon completion of the intervention, patients in arms I and II receive a printout to take with them to their upcoming appointment. For those in arm I, this printout will include their top three attributes, their preference-matched test, and their final test choice. For those in arm II, this printout will include a list of the four screening tests but will not list their final test choice.
Patients in arm I and II undergo a 3-day follow-up telephone interview. Medical charts of all patients in all 3 arms are reviewed at 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Kelsey-Seybold Clinic, Houston, Tx Study Coordinator: Bettencourt , Judy ( ) Email: Judith.L.Bettencourt@uth.tmc.e Phone: 713-500-9754
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 |
|---|---|---|
| computer-assisted intervention | Other | – |
| educational intervention | Other | – |
| medical chart review | Other | – |
Primary outcome
Adherence to colorectal cancer screening at 12 months post-intervention
Time frame: 12 months
4 secondary outcomes
Elements of informed decision making
Time frame: 12 months
Knowledge about screening options
Time frame: 12 months
Decisional conflict and satisfaction
Time frame: 12 months
Intention to get screened
Time frame: 12 months
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 21 Dec 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.
Sarah T. Hawley, PhD, MPH principal investigator
University of Michigan Rogel Cancer Center
3 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 University of Michigan Rogel Cancer Center 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?
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 21 Dec 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.
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?
Adherence to colorectal cancer screening at 12 months post-intervention (time frame: 12 months). 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 21 Dec 2012.