Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colorecatal Cancer Screening Activation
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention Group
Arm Description
Patients of physicians randomly assigned to the control group received usual care
This group will receive the behavioral intervention.
Outcomes
Primary Outcome Measures
Completion of Colorectal cancer screening
Secondary Outcome Measures
physician recommendation for colorectal cancer screening
Patient adherence to physician recommended colorectal cancer screening test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00836303
Brief Title
Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
Official Title
A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening Among Latino Immigrants in a Primary Care Facility
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients of physicians randomly assigned to the control group received usual care
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This group will receive the behavioral intervention.
Intervention Type
Behavioral
Intervention Name(s)
Colorecatal Cancer Screening Activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of Colorectal cancer screening
Time Frame
3 months
Secondary Outcome Measure Information:
Title
physician recommendation for colorectal cancer screening
Title
Patient adherence to physician recommended colorectal cancer screening test
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca M Gany, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hispanichealth.org/
Description
Related Info
Learn more about this trial
Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
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