- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742729
Increasing Colorectal Cancer Screening Among Filipino Americans
July 28, 2016 updated by: Jonsson Comprehensive Cancer Center
Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to increase colorectal cancer (CRC) screening among older Filipino Americans, specifically the use of fecal occult blood tests (FOBTs).
We will design a culturally specific intervention, an educational small group discussion with a Filipino health professional.
The effect of the intervention will be tested with 620 Filipino Americans.
Subjects will be recruited at community-based organizations and churches and invited to join a 1 1/2 hour discussion of health issues with their partner and some of their friends.
A third of the subjects will discuss exercise (control group), another third will discuss CRC and receive an FOBT kit, and the remaining third will discuss CRC and will not receive an FOBT kit.
Three months after the group session, subjects in the CRC (intervention) groups will receive a letter reminding them to get screened.
All subjects will be interviewed before and 6 months after the group sessions to assess CRC screening levels in the three groups.
Self-reported CRC screening will be verified by a review of their medical records.
Study Type
Interventional
Enrollment (Actual)
906
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-6900
- Division of Cancer Prevention and Control Research, Univ of California Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being: a Filipino American,
- Member of or affiliated with participating community agencies, between the ages of 50 and 70,
- Not up-to-date with colorectal cancer screening at baseline
Exclusion Criteria:
- Being younger than 50 or older than 70 years,
- Not being a member or not affiliated with participating community agencies,
- Not being Filipino American or up-to-date with colorectal cancer screening at baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Educational small group session with free FOBT kit
|
Educational small group session with free FOBT kit
Other Names:
|
|
Experimental: Arm 2
Educational small group session with no FOBT kit
|
Educational small group session with no FOBT kit
Other Names:
|
|
Sham Comparator: Arm 3
Control
|
Educational small group session, exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Receipt of a colorectal cancer screening test
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Knowledge and attitudes regarding CRC screening.
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Annette E Maxwell, Dr.P.H., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Maxwell AE, Danao LL, Crespi CM, Antonio C, Garcia GM, Bastani R. Disparities in the receipt of fecal occult blood test versus endoscopy among Filipino American immigrants. Cancer Epidemiol Biomarkers Prev. 2008 Aug;17(8):1963-7. doi: 10.1158/1055-9965.EPI-07-2800.
- Maxwell AE, Bastani R, Danao LL, Antonio C, Garcia GM, Crespi CM. Results of a community-based randomized trial to increase colorectal cancer screening among Filipino Americans. Am J Public Health. 2010 Nov;100(11):2228-34. doi: 10.2105/AJPH.2009.176230. Epub 2010 Sep 23.
- Maxwell AE, Bastani R, Crespi CM, Danao LL, Cayetano RT. Behavioral mediators of colorectal cancer screening in a randomized controlled intervention trial. Prev Med. 2011 Feb;52(2):167-73. doi: 10.1016/j.ypmed.2010.11.007. Epub 2010 Nov 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
August 27, 2008
First Submitted That Met QC Criteria
August 27, 2008
First Posted (Estimate)
August 28, 2008
Study Record Updates
Last Update Posted (Estimate)
August 1, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSGT-04-210-01-CPPB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.