Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836303
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 4, 2009
Information provided by:
New York University School of Medicine

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Colorecatal Cancer Screening Activation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening Among Latino Immigrants in a Primary Care Facility
Study Start Date : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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 {}. 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.

Primary Outcome Measures :
  1. Completion of Colorectal cancer screening [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. physician recommendation for colorectal cancer screening
  2. Patient adherence to physician recommended colorectal cancer screening test [ Time Frame: 3 Months ]

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836303

United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Francesca M Gany, MD NYU School of Medicine

Additional Information:
Responsible Party: Francesca M. Gany/Associate Professor, New York University School of Medicine Identifier: NCT00836303     History of Changes
Other Study ID Numbers: T01CD000146 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases