Colorectal NeoplasmsNCT00947206
Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans
A study testing LHWO about CRC and Nutrition Education + CRC brochure in people with Colorectal Neoplasms, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This proposed project seeks to expand understanding of what constitutes a "lay health worker (LHW)," how those characteristics determine the effectiveness of LHWs as health educators on colorectal cancer (CRC) screening, and the relationship of those characteristics to a particular community and culture. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- LHWO about CRC and Nutrition Education + CRC brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 909 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to May 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identified as Chinese or Chinese Americans
- age 50 to 75
- speak a language that the LHW can speak (Cantonese, Mandarin, and/or English)
- live and intend to stay in SF for at least 12 months
- have no personal history of CRC
- have no medical problems preventing them from attending educational sessions
- willing to participate in a study about health behaviors involving nutrition or CRC screening
Who cannot join
- anyone who does not meet the above criteria
- those unable to understand informed consent form written in their language
- those too debilitated to attend educational sessions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NICOS
San Francisco, California, 94108
San Francisco State University
San Francisco, California, 94132
About this study
This proposed project seeks to expand understanding of what constitutes a "lay health worker (LHW)," how those characteristics determine the effectiveness of LHWs as health educators on colorectal cancer (CRC) screening, and the relationship of those characteristics to a particular community and culture. Using quantitative and qualitative methods and a community-based participatory research (CBPR) approach, the project will develop and implement a group randomized controlled trial to evaluate LHW effectiveness in promoting CRC screening among Chinese Americans age 50 to 75 with a pilot component to evaluate the role of Traditional Chinese Medicine (TCM) healers as health educators.
The investigators will conduct focus groups with community participants to revise training materials developed in a prior pilot project. The investigators will also conduct ethnographic observations of TCM healers and focus groups with their clients to refine the training materials. The investigators will recruit 26 LHWs to be assigned to the intervention arm and 26 to the comparison arm. The LHWs will each recruit 12 participants from their social network for a total of 312 participants in each arm. The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt. The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors, with validation of self-reports. An additional 10 TCM healers will also participate as LHWs. They will each recruit 12 participants for LHWO. There will be extensive ethnographic observations as well as post-intervention focus groups of LHWO activities, LHWs, and LHWO participants to assess the factors that contribute to effective LHWO.
The primary hypothesis is that the increase in the proportion of participants who report ever having had a CRC screening test in the experimental group (LHWO about CRC) will be greater than the increase in the comparison group (nutrition education + CRC brochure).
Read the detailed description
The secondary hypotheses are:
- The increase in the proportion of participants who are up-to-date for CRC screening in the experimental group will be greater than the increase in the comparison group;
- The increase in the proportion of participants who intend to obtain CRC screening in the next 6 months in the experimental group will be greater than the increase in the comparison group;
- The increase in the proportion of participants who are aware of CRC screening tests in the experimental group will be greater than the increase in the comparison group;
- Self-efficacy is a mediator between intervention and receipt of CRC screening.
- Knowledge is a mediator between intervention and receipt of CRC screening.
- Gender is a moderator between intervention and receipt of CRC screening.
Although the pilot project intervention was effective in both men and women, the sample was too small to determine if there was a gender effect. Based on the extensive literature on LHWO among women, the intervention may be more effective among women than men.
Additional secondary hypotheses will apply the primary hypothesis and secondary hypotheses 1-3 to individual CRC tests (FOBT, sigmoidoscopy, or colonoscopy) rather than to the combined outcome.
- Conditions
- Colorectal Neoplasms
- Being tested
- LHWO about CRC, Nutrition Education + CRC brochure
- Keywords
- Chinese Americans, lay health worker outreach, colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHWO about CRCBehavioural
2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt
Nutrition Education + CRC brochureBehavioural
Bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.
| Study group | Role | What they receive |
|---|---|---|
| LHWO about CRC | Experimental | The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt. Receives: Behavioral: LHWO about CRC |
| Nutrition education + CRC brochure | Active comparator | The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. Receives: Behavioral: Nutrition Education + CRC brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
ever had a CRC screening test
Measured: 6 months
Secondary outcomes (1)
up-to-date for CRC screening
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 909 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco State University, NICOS Chinese Health Coalition
- Responsible party
- Sponsor
- Investigators
- Tung T Nguyen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947206
- Sponsor's protocol ID
- 1R01CA138778-01A1
- Status last verified
- May 2014
- First submitted
- 24 Jul 2009
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong ST, Gildengorin G, Nguyen T, Mock J. Disparities in colorectal cancer screening rates among Asian Americans and non-Latino whites. Cancer. 2005 Dec 15;104(12 Suppl):2940-7. doi: 10.1002/cncr.21521.
PubMed 16276538Mock J, McPhee SJ, Nguyen T, Wong C, Doan H, Lai KQ, Nguyen KH, Nguyen TT, Bui-Tong N. Effective lay health worker outreach and media-based education for promoting cervical cancer screening among Vietnamese American women. Am J Public Health. 2007 Sep;97(9):1693-700. doi: 10.2105/AJPH.2006.086470. Epub 2007 Feb 28.
PubMed 17329652Wu AP, Burke A, LeBaron S. Use of traditional medicine by immigrant Chinese patients. Fam Med. 2007 Mar;39(3):195-200.
PubMed 17323211Nguyen TT, Love MB, Liang C, Fung LC, Nguyen T, Wong C, Gildengorin G, Woo K. A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. J Cancer Educ. 2010 Sep;25(3):405-12. doi: 10.1007/s13187-010-0064-3. Epub 2010 Mar 5.
PubMed 20204570Nguyen TT, Tsoh JY, Woo K, Stewart SL, Le GM, Burke A, Gildengorin G, Pasick RJ, Wang J, Chan E, Fung LC, Jih J, McPhee SJ. Colorectal Cancer Screening and Chinese Americans: Efficacy of Lay Health Worker Outreach and Print Materials. Am J Prev Med. 2017 Mar;52(3):e67-e76. doi: 10.1016/j.amepre.2016.10.003. Epub 2016 Dec 13.
PubMed 27986352
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans
- ClinicalTrials.gov ID
- NCT00947206
- Acronym / sponsor ID
- 1R01CA138778-01A1
- Conditions
- Colorectal Neoplasms
- Keywords
- Chinese Americans, lay health worker outreach, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 909 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco State University, NICOS Chinese Health Coalition
- Study start
- Sep 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jul 2009 (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.
This proposed project seeks to expand understanding of what constitutes a "lay health worker (LHW)," how those characteristics determine the effectiveness of LHWs as health educators on colorectal cancer (CRC) screening, and the relationship of those characteristics to a particular community and culture. Using quantitative and qualitative methods and a community-based participatory research (CBPR) approach, the project will develop and implement a group randomized controlled trial to evaluate LHW effectiveness in promoting CRC screening among Chinese Americans age 50 to 75 with a pilot component to evaluate the role of Traditional Chinese Medicine (TCM) healers as health educators.
The investigators will conduct focus groups with community participants to revise training materials developed in a prior pilot project. The investigators will also conduct ethnographic observations of TCM healers and focus groups with their clients to refine the training materials. The investigators will recruit 26 LHWs to be assigned to the intervention arm and 26 to the comparison arm. The LHWs will each recruit 12 participants from their social network for a total of 312 participants in each arm. The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt. The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors, with validation of self-reports. An additional 10 TCM healers will also participate as LHWs. They will each recruit 12 participants for LHWO. There will be extensive ethnographic observations as well as post-intervention focus groups of LHWO activities, LHWs, and LHWO participants to assess the factors that contribute to effective LHWO.
The primary hypothesis is that the increase in the proportion of participants who report ever having had a CRC screening test in the experimental group (LHWO about CRC) will be greater than the increase in the comparison group (nutrition education + CRC brochure).
Detailed description
The secondary hypotheses are:
- The increase in the proportion of participants who are up-to-date for CRC screening in the experimental group will be greater than the increase in the comparison group;
- The increase in the proportion of participants who intend to obtain CRC screening in the next 6 months in the experimental group will be greater than the increase in the comparison group;
- The increase in the proportion of participants who are aware of CRC screening tests in the experimental group will be greater than the increase in the comparison group;
- Self-efficacy is a mediator between intervention and receipt of CRC screening.
- Knowledge is a mediator between intervention and receipt of CRC screening.
- Gender is a moderator between intervention and receipt of CRC screening.
Although the pilot project intervention was effective in both men and women, the sample was too small to determine if there was a gender effect. Based on the extensive literature on LHWO among women, the intervention may be more effective among women than men.
Additional secondary hypotheses will apply the primary hypothesis and secondary hypotheses 1-3 to individual CRC tests (FOBT, sigmoidoscopy, or colonoscopy) rather than to the combined outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LHWO about CRC | Experimental | Behavioral: LHWO about CRCThe intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt. |
| Nutrition education + CRC brochure | Active comparator | Behavioral: Nutrition Education + CRC brochureThe comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identified as Chinese or Chinese Americans
- age 50 to 75
- speak a language that the LHW can speak (Cantonese, Mandarin, and/or English)
- live and intend to stay in SF for at least 12 months
- have no personal history of CRC
Key exclusion criteria (3 listed)
- anyone who does not meet the above criteria
- those unable to understand informed consent form written in their language
- those too debilitated to attend educational sessions
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 |
|---|---|---|
| LHWO about CRC2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt | Behavioural | LHWO about CRC |
| Nutrition Education + CRC brochureBilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. | Behavioural | Nutrition education + CRC brochure |
Primary outcome
ever had a CRC screening test
Time frame: 6 months
1 secondary outcome
up-to-date for CRC screening
Time frame: 6 months
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 8 May 2014.
- Background: PubMed 16276538Wong ST, Gildengorin G, Nguyen T, Mock J. Disparities in colorectal cancer screening rates among Asian Americans and non-Latino whites. Cancer. 2005 Dec 15;104(12 Suppl):2940-7. doi: 10.1002/cncr.21521.
- Background: PubMed 17329652Mock J, McPhee SJ, Nguyen T, Wong C, Doan H, Lai KQ, Nguyen KH, Nguyen TT, Bui-Tong N. Effective lay health worker outreach and media-based education for promoting cervical cancer screening among Vietnamese American women. Am J Public Health. 2007 Sep;97(9):1693-700. doi: 10.2105/AJPH.2006.086470. Epub 2007 Feb 28.
- Background: PubMed 17323211Wu AP, Burke A, LeBaron S. Use of traditional medicine by immigrant Chinese patients. Fam Med. 2007 Mar;39(3):195-200.
- Background: PubMed 20204570Nguyen TT, Love MB, Liang C, Fung LC, Nguyen T, Wong C, Gildengorin G, Woo K. A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. J Cancer Educ. 2010 Sep;25(3):405-12. doi: 10.1007/s13187-010-0064-3. Epub 2010 Mar 5.
- Derived from this study: PubMed 27986352Nguyen TT, Tsoh JY, Woo K, Stewart SL, Le GM, Burke A, Gildengorin G, Pasick RJ, Wang J, Chan E, Fung LC, Jih J, McPhee SJ. Colorectal Cancer Screening and Chinese Americans: Efficacy of Lay Health Worker Outreach and Print Materials. Am J Prev Med. 2017 Mar;52(3):e67-e76. doi: 10.1016/j.amepre.2016.10.003. Epub 2016 Dec 13.
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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.
Tung T Nguyen, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LHWO about CRC and Nutrition Education + CRC brochure in people with Colorectal Neoplasms, run by University of California, San Francisco at 2 sites 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 7 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
ever had a CRC screening test (time frame: 6 months). 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 NCT00947206, which also lists 5 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 8 May 2014.