Preventive MeasuresGet ScreenedNCT00818857
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
A study testing Early Intervention and Delayed intervention in people with Preventive Measures, run by University of Rochester.
Trial summary
The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Preventive Measures
- What is being tested?
- Early Intervention and Delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Feb 2013
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 50-75 yrs.
- Women age 40-75 yrs
- One primary care visit in past 2 years.
Who cannot join
- High risk for colorectal or breast cancer.
About this study
The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients
Read the detailed description
This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.
- Conditions
- Preventive Measures
- Being tested
- Early Intervention, Delayed intervention
- Keywords
- cancer screening, screening disparities, underserved populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early InterventionBehavioural
At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.
Delayed interventionBehavioural
One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Early intervention. Receives: Behavioral: Early Intervention |
| 2 | Active comparator | Delayed intervention Receives: Behavioral: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome.
Measured: End of project, 12/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionFeb 2013
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 Preventive MeasuresStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Kevin Fiscella, University of Rochester
- Investigators
- Kevin Fiscella, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818857
- Sponsor's protocol ID
- RSRB 00025557
- Acronym
- Get Screened
- Status last verified
- Jun 2016
- First submitted
- 6 Jan 2009
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiscella K, Humiston S, Hendren S, Winters P, Idris A, Li SX, Ford P, Specht R, Marcus S. A multimodal intervention to promote mammography and colorectal cancer screening in a safety-net practice. J Natl Med Assoc. 2011 Aug;103(8):762-8. doi: 10.1016/s0027-9684(15)30417-x.
PubMed 22046855Fiscella K, Yosha A, Hendren SK, Humiston S, Winters P, Ford P, Loader S, Specht R, Pope S, Adris A, Marcus S. Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice. BMC Health Serv Res. 2010 Sep 23;10:280. doi: 10.1186/1472-6963-10-280.
PubMed 20863395
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
- ClinicalTrials.gov ID
- NCT00818857
- Acronym / sponsor ID
- Get Screened / RSRB 00025557
- Conditions
- Preventive Measures
- Keywords
- cancer screening, screening disparities, underserved populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Jan 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.
The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients
Detailed description
This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Early InterventionEarly intervention. |
| 2 | Active comparator | Behavioral: Delayed interventionDelayed intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men age 50-75 yrs.
- Women age 40-75 yrs
- One primary care visit in past 2 years.
Key exclusion criteria (1 listed)
- High risk for colorectal or breast cancer.
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 |
|---|---|---|
| Early InterventionAt the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests. | Behavioural | 1 |
| Delayed interventionOne year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests. | Behavioural | 2 |
Primary outcome
To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome.
Time frame: End of project, 12/2011
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 2016.
- Derived from this study: PubMed 22046855Fiscella K, Humiston S, Hendren S, Winters P, Idris A, Li SX, Ford P, Specht R, Marcus S. A multimodal intervention to promote mammography and colorectal cancer screening in a safety-net practice. J Natl Med Assoc. 2011 Aug;103(8):762-8. doi: 10.1016/s0027-9684(15)30417-x.
- Derived from this study: PubMed 20863395Fiscella K, Yosha A, Hendren SK, Humiston S, Winters P, Ford P, Loader S, Specht R, Pope S, Adris A, Marcus S. Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice. BMC Health Serv Res. 2010 Sep 23;10:280. doi: 10.1186/1472-6963-10-280.
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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.
Kevin Fiscella, MD, MPH principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Early Intervention and Delayed intervention in people with Preventive Measures, run by University of Rochester.
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 1 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 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (time frame: End of project, 12/2011). 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 NCT00818857, 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 2016.