Colorectal CancerAANCARTLHWNCT01904890
AANCART Research Project on Lay Health Workers and Asian Americans
A study testing CRC Prevention and Screening Education and Nutrition Education in people with Colorectal Cancer, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This is a behavioral research study to evaluate the effectiveness of a type of health education, lay health worker (LHWs), on increasing the use of a routine health behavior, colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CRC Prevention and Screening Education and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2012to Aug 2015
- 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 Filipino, Hmong, or Korean Americans
- age 50 to 75
- speak a language that the lay health worker (LHW) can speak such as Tagalog, Ilocano, Hmong, Korean, or English
- live in relevant area and intend to stay there for at least 12 months
- are willing to participate in a study about health behaviors involving nutrition or CRC screening.
Who cannot join
- personal history of CRC
- medical problems which may prevent them from attending 2 educational sessions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Hawai'i at Manoa
Honolulu, Hawaii, 96822
University of California Los Angeles
Los Angeles, California, 90095
University of California Davis
Sacramento, California, 95817
About this study
Official title: Asian American Network for Cancer Awareness, Research, and Training (AANCART): The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans
This is a behavioral research study to evaluate the effectiveness of a type of health education, lay health worker (LHWs), on increasing the use of a routine health behavior, colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening. 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 Asian Americans age 50 to 75. The investigators will conduct focus groups and individual interviews with community participants to revise training and survey materials developed in prior projects. The investigators will recruit LHWs to be randomly assigned to the intervention arm and to the comparison arm. The LHWs will each recruit 15 participants from their social network. Intervention LHWs will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors. The investigators will also conduct ethnographic observations of LHWs and their participants during the small group sessions and post- intervention focus groups to understand how such a health education approach may work.
- Conditions
- Colorectal Cancer
- Being tested
- CRC Prevention and Screening Education, Nutrition Education
- Keywords
- Asian Americans, colorectal cancer screening, cancer prevention, Filipinos Americans, Hmong Americans, Korean Americans, Randomized Controlled Trials
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC Prevention and Screening EducationBehavioural
Refer to Arm Description
Nutrition EducationBehavioural
Refer to Arm Description
| Study group | Role | What they receive |
|---|---|---|
| CRC Prevention and Screening Education | Experimental | Intervention Lay Health Workers (LHWs) will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. Receives: Behavioral: CRC Prevention and Screening Education |
| Nutrition Education | Active comparator | LHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach session on CRC screening. Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of CRC Screening
self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy
Measured: Baseline to 6 months
Secondary outcomes (2)
Up-to-date CRC screening receipt
self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years
Measured: Baseline to 6 months
CRC screening Intention
self-report of intending to obtain CRC screening in 6 months
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of California, Los Angeles, University of Hawaii, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tung Nguyen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904890
- Sponsor's protocol ID
- U54CA153499 Sub7323
- Other IDs
- U54CA153499
- Acronym
- AANCARTLHW
- Status last verified
- Dec 2015
- First submitted
- 10 Jul 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian American Network for Cancer Awareness, Research, and Training (AANCART): The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans
- ClinicalTrials.gov ID
- NCT01904890
- Acronym / sponsor ID
- AANCARTLHW / U54CA153499 Sub7323
- Conditions
- Colorectal Cancer
- Keywords
- Asian Americans, colorectal cancer screening, cancer prevention, Filipinos Americans, Hmong Americans, Korean Americans, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis, University of California, Los Angeles, University of Hawaii, National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Jul 2013 (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 is a behavioral research study to evaluate the effectiveness of a type of health education, lay health worker (LHWs), on increasing the use of a routine health behavior, colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening. 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 Asian Americans age 50 to 75. The investigators will conduct focus groups and individual interviews with community participants to revise training and survey materials developed in prior projects. The investigators will recruit LHWs to be randomly assigned to the intervention arm and to the comparison arm. The LHWs will each recruit 15 participants from their social network. Intervention LHWs will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors. The investigators will also conduct ethnographic observations of LHWs and their participants during the small group sessions and post- intervention focus groups to understand how such a health education approach may work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRC Prevention and Screening Education | Experimental | Behavioral: CRC Prevention and Screening EducationIntervention Lay Health Workers (LHWs) will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. |
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationLHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach 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 (5 listed)
- self-identified as Filipino, Hmong, or Korean Americans
- age 50 to 75
- speak a language that the lay health worker (LHW) can speak such as Tagalog, Ilocano, Hmong, Korean, or English
- live in relevant area and intend to stay there for at least 12 months
- are willing to participate in a study about health behaviors involving nutrition or CRC screening.
Key exclusion criteria (2 listed)
- personal history of CRC
- medical problems which may prevent them from attending 2 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 |
|---|---|---|
| CRC Prevention and Screening EducationRefer to Arm Description | Behavioural | CRC Prevention and Screening Education |
| Nutrition EducationRefer to Arm Description | Behavioural | Nutrition Education |
Primary outcome
Receipt of CRC Screening
Time frame: Baseline to 6 months
self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy
2 secondary outcomes
Up-to-date CRC screening receipt
Time frame: Baseline to 6 months
CRC screening Intention
Time frame: Baseline to 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 30 Dec 2015.
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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 Nguyen, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRC Prevention and Screening Education and Nutrition Education in people with Colorectal Cancer, run by University of California, San Francisco at 3 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 5 inclusion and 2 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Receipt of CRC Screening (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2015.