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Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00836303
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 2, 2009
February 2, 2009
December 2005
June 2007   (final data collection date for primary outcome measure)
Completion of Colorectal cancer screening [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • physician recommendation for colorectal cancer screening [ Designated as safety issue: No ]
  • Patient adherence to physician recommended colorectal cancer screening test [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening Among Latino Immigrants in a Primary Care Facility

This study will assess the effectiveness of a culturally-responsive intervention to increase colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of a large municipal Hospital in New York City. propose a randomized, control trial to determine if a video-based intervention, that educates and activates the patient and the provider via the patient, will increase rates of CRC screening referrals compared to a control group.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Colorectal Cancer
Behavioral: 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.
  • No Intervention: Control
    Patients of physicians randomly assigned to the control group received usual care
  • Experimental: Intervention Group
    This group will receive the behavioral intervention.
    Intervention: Behavioral: Colorecatal Cancer Screening Activation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
July 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult Latino immigrants
  • 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:

  • Personal or family history of colorectal cancer.
  • 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.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836303
T01 CD000146
No
Francesca M. Gany/Associate Professor, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Francesca M Gany, MD NYU School of Medicine
New York University School of Medicine
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP