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
  Purpose

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 Intervention
Colorectal Cancer
Behavioral: Colorecatal Cancer Screening Activation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Completion of Colorectal cancer screening [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 130
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 {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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00836303

Locations
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
Investigators
Principal Investigator: Francesca M Gany, MD NYU School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Francesca M. Gany/Associate Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00836303     History of Changes
Other Study ID Numbers: T01 CD000146
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014