Colorectal CancerNCT00012922
Low Literacy Intervention for Colorectal Cancer Screening
A study testing Low Literacy Intervention for Colorectal Cancer Screening in people with Colorectal Cancer, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Low Literacy Intervention for Colorectal Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2003
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 50 with average risk for colorectal cancer. Patients with family history and/or personal history excluded, as well as those up to date on colorectal cancer screening.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Chicago, Illinois, 60611
About this study
Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.
Read the detailed description
Background:
Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.
Objectives:
The objectives of this study were to 1) test whether a health care provider-directed intervention increased colorectal cancer screening rates in an urban VA medical center and 2) evaluate the cost-effectiveness of the intervention.
Methods:
The study was a randomized controlled trial, conducted at two clinic firms at a VA Medical Center in Chicago. Eligible patients were men, age 50 and older, had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. Health care providers in the intervention firm attended a workshop on colorectal cancer screening. Every 4-6 months they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. Medical records were reviewed for colorectal cancer screening recommendations and completion. Literacy level was assessed in a subset of patients. In the cost-effectiveness analysis, resource and cost estimates were derived.
Status:
The project is complete.
- Conditions
- Colorectal Cancer
- Being tested
- Low Literacy Intervention for Colorectal Cancer Screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Literacy Intervention for Colorectal Cancer ScreeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Low Literacy Intervention for Colorectal Cancer Screening |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionApr 2003
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charles L. Bennett, MD PhD MPP, Principal investigator, Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012922
- Sponsor's protocol ID
- PCI 99-158
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Literacy Intervention for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT00012922
- Acronym / sponsor ID
- PCI 99-158
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Apr 2003 (actual)
- First posted
- 16 Mar 2001 (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.
Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.
Detailed description
Background:
Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.
Objectives:
The objectives of this study were to 1) test whether a health care provider-directed intervention increased colorectal cancer screening rates in an urban VA medical center and 2) evaluate the cost-effectiveness of the intervention.
Methods:
The study was a randomized controlled trial, conducted at two clinic firms at a VA Medical Center in Chicago. Eligible patients were men, age 50 and older, had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. Health care providers in the intervention firm attended a workshop on colorectal cancer screening. Every 4-6 months they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. Medical records were reviewed for colorectal cancer screening recommendations and completion. Literacy level was assessed in a subset of patients. In the cost-effectiveness analysis, resource and cost estimates were derived.
Status:
The project is complete.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Low Literacy Intervention for Colorectal Cancer Screening |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 50 with average risk for colorectal cancer. Patients with family history and/or personal history excluded, as well as those up to date on colorectal cancer screening.
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 |
|---|---|---|
| Low Literacy Intervention for Colorectal Cancer Screening | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 Apr 2015.
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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.
Charles L. Bennett, MD PhD MPP principal investigator
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Literacy Intervention for Colorectal Cancer Screening in people with Colorectal Cancer, run by US Department of Veterans Affairs 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 1 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 7 Apr 2015. 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.
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 Apr 2015.