Colorectal CancerNCT00742729
Increasing Colorectal Cancer Screening Among Filipino Americans
A study testing Arm 1, Arm 2 and Arm 3 in people with Colorectal Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Arm 1, Arm 2 and Arm 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 906 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Cancer Prevention and Control Research, Univ of California Los Angeles
Los Angeles, California, 90095-6900
About this study
Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Arm 1, Arm 2, Arm 3
- Keywords
- Colorectal cancer screening, Fecal occult blood test, Endoscopies, Filipino American immigrants, Community based organizations and churches
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1Behavioural
Also called Intervention 1
Educational small group session with free FOBT kit
Arm 2Behavioural
Also called Intervention 2
Educational small group session with no FOBT kit
Arm 3Behavioural
Also called Control
Educational small group session, exercise
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Educational small group session with free FOBT kit Receives: Behavioral: Arm 1 |
| Arm 2 | Experimental | Educational small group session with no FOBT kit Receives: Behavioral: Arm 2 |
| Arm 3 | Sham comparator | Control Receives: Behavioral: Arm 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of a colorectal cancer screening test
Measured: 6 months post-intervention
Secondary outcomes (1)
Knowledge and attitudes regarding CRC screening.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startSep 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Annette E Maxwell, Dr.P.H., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742729
- Sponsor's protocol ID
- RSGT-04-210-01-CPPB
- Status last verified
- Nov 2010
- First submitted
- 27 Aug 2008
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18708385Maxwell 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.
PubMed 20864724Maxwell 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.
PubMed 21111754
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Colorectal Cancer Screening Among Filipino Americans
- ClinicalTrials.gov ID
- NCT00742729
- Acronym / sponsor ID
- RSGT-04-210-01-CPPB
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, Fecal occult blood test, Endoscopies, Filipino American immigrants, Community based organizations and churches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Sep 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among Filipino Americans.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Arm 1Educational small group session with free FOBT kit |
| Arm 2 | Experimental | Behavioral: Arm 2Educational small group session with no FOBT kit |
| Arm 3 | Sham comparator | Behavioral: Arm 3Control |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1Also: Intervention 1Educational small group session with free FOBT kit | Behavioural | Arm 1 |
| Arm 2Also: Intervention 2Educational small group session with no FOBT kit | Behavioural | Arm 2 |
| Arm 3Also: ControlEducational small group session, exercise | Behavioural | Arm 3 |
Primary outcome
Receipt of a colorectal cancer screening test
Time frame: 6 months post-intervention
1 secondary outcome
Knowledge and attitudes regarding CRC screening.
Time frame: 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Results publication: PubMed 18708385Maxwell 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.
- Results publication: PubMed 20864724Maxwell 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.
- Results publication: PubMed 21111754Maxwell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette E Maxwell, Dr.P.H. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1, Arm 2 and Arm 3 in people with Colorectal Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of a colorectal cancer screening test (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742729, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.