Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
NCT ID: NCT00836303
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2005-12-31
2007-07-31
Brief Summary
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Colorectal cancer remains one of the most prevalent cancers among the general population, as well as in the Latino population, in the United States. There are serious disparities in CRC screening rates between different races and socio-demographic populations (American Cancer Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are one of the populations most affected by the lack of screening, reducing their relative benefit from preventive CRC services. This study will use a modified version of an intervention developed and studied by Pignone (11), with changes made to be tailored specifically to the Latino immigrant population. The outcomes measured will include referral for CRC screening and adherence with providers' referrals. In addition, the investigators will measure screening rates for other cancer screening tests to assess if the CRC intervention displaces or facilitates other cancer screening. A sample of Latino immigrants seeking care at the primary care clinic of Bellevue Hospital will be accrued through a process of consecutive sampling until reaching the proposed sample size of 101 patients in each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention the investigators will use the z-test and will report the difference in proportion between the intervention and the control group with a 95% CI, adjusting for intra-class correlations and covariates. A repeated measurement analysis with logistic regression will be used to examine the effects of covariates.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Patients of physicians randomly assigned to the control group received usual care
No interventions assigned to this group
Intervention Group
This group will receive the behavioral intervention.
Colorecatal Cancer Screening Activation
Research assistants showed intervention patients a colorectal cancer educational video in Spanish on a portable personal digital video display device while the patients were waiting for their visit. The 11-minute video was developed by the National Alliance for Hispanic Health and was accompanied by a brochure with key information from the video {http://www.hispanichealth.org/publication/}. Intervention patients were also given a one-page reminder to hand to their physicians notifying them 1) of their patients' eligibility for colorectal cancer screening, and 2) of their patients' receipt of CRC educational material.
Interventions
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Colorecatal Cancer Screening Activation
Research assistants showed intervention patients a colorectal cancer educational video in Spanish on a portable personal digital video display device while the patients were waiting for their visit. The 11-minute video was developed by the National Alliance for Hispanic Health and was accompanied by a brochure with key information from the video {http://www.hispanichealth.org/publication/}. Intervention patients were also given a one-page reminder to hand to their physicians notifying them 1) of their patients' eligibility for colorectal cancer screening, and 2) of their patients' receipt of CRC educational material.
Eligibility Criteria
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Inclusion Criteria
* Men and women
* 50 years and older
* Having had at least 2 previous visits to the primary care clinic in the past 2 years
Exclusion Criteria
* Had fecal occult blood testing (FOBT) in the past year, or flexible sigmoidoscopy or barium enema in the past 5 years, or colonoscopy in the past 10 years.
* Lower gastrointestinal symptoms, including bleeding, pain, diarrhea and/or constipation.
* Too ill to participate
* Any cancer diagnosis other than non-melanoma skin cancer.
50 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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New York University School of Medicine
Principal Investigators
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Francesca M Gany, MD
Role: PRINCIPAL_INVESTIGATOR
NYU School of Medicine
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Related Links
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Related Info
Other Identifiers
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