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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00742729
Other study ID # RSGT-04-210-01-CPPB
Secondary ID
Status Completed
Phase N/A
First received August 27, 2008
Last updated July 28, 2016
Start date September 2004
Est. completion date June 2009

Study information

Verified date November 2010
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans.


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.


Recruitment information / eligibility

Status Completed
Enrollment 906
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Arm 1
Educational small group session with free FOBT kit
Arm 2
Educational small group session with no FOBT kit
Arm 3
Educational small group session, exercise

Locations

Country Name City State
United States Division of Cancer Prevention and Control Research, Univ of California Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.EP — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Receipt of a colorectal cancer screening test 6 months post-intervention No
Secondary Knowledge and attitudes regarding CRC screening. 6 months post-intervention No
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