Colorectal CarcinomaNCT03115372
Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans
A study testing Educational Intervention, Informational Intervention and Survey Administration in people with Colorectal Carcinoma and Health Status Unknown, run by University of California, San Francisco at 4 sites in United States.
Trial summary
This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma, Health Status Unknown, Healthy Subject
- What is being tested?
- Educational Intervention, Informational Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 982 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2012to 1 Sep 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
- LHW: self-identified as Filipino, Hmong, or Korean Americans
- LHW: age 18 or older
- LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
- LHW: Live in the relevant area and intend to stay there for the next 12 months
- PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
- PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
- PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
- PARTICIPANTS: 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
4 sites in 1 country.
United States4 sites
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).
II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.
OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.
GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.
After completion of the study, patients are followed up at 2 months.
- Conditions
- Colorectal Carcinoma, Health Status Unknown, Healthy Subject
- Being tested
- Educational Intervention, Informational Intervention, Survey Administration, Telephone-Based Intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend CRC education session
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend healthy nutrition session
Informational InterventionOther
Receive CRC screening brochure
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive telephone reminder about CRC screening
Telephone-Based InterventionBehavioural
Receive telephone reminder about healthy nutrition
| Study group | Role | What they receive |
|---|---|---|
| Group I (CRC education) | Experimental | LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening. Receives: Other: Educational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| Group II (CRC brochure) | Active comparator | LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening. Receives: Other: Educational Intervention; Other: Informational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who report ever having had a CRC screening test
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.
Measured: Baseline to 6 months
Secondary outcomes (2)
Proportion of participants who are up-to-date for CRC screening
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
Measured: At 6 months
Proportion of participants who intend to obtain CRC screening in the next 6 months
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startFeb 2012
- Primary completion1 Jul 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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
- 982 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tung Nguyen, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115372
- Sponsor's protocol ID
- 11056
- Other IDs
- NCI-2017-00515, U54CA153499
- Status last verified
- Jul 2020
- First submitted
- 11 Apr 2017
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
- ClinicalTrials.gov ID
- NCT03115372
- Acronym / sponsor ID
- 11056
- Conditions
- Colorectal Carcinoma, Health Status Unknown, Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).
II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.
OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.
GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.
After completion of the study, patients are followed up at 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CRC education) | Experimental | Other: Educational Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionLHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening. |
| Group II (CRC brochure) | Active comparator | Other: Educational Intervention, Other: Informational Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionLHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend 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 (8 listed)
- LHW: self-identified as Filipino, Hmong, or Korean Americans
- LHW: age 18 or older
- LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
- LHW: Live in the relevant area and intend to stay there for the next 12 months
- PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend CRC education session | Other | Group I (CRC education) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend healthy nutrition session | Other | Group II (CRC brochure) |
| Informational InterventionReceive CRC screening brochure | Other | Group II (CRC brochure) |
| Survey AdministrationAncillary studies | Other | Group I (CRC education), Group II (CRC brochure) |
| Telephone-Based InterventionReceive telephone reminder about CRC screening | Behavioural | Group I (CRC education) |
| Telephone-Based InterventionReceive telephone reminder about healthy nutrition | Behavioural | Group II (CRC brochure) |
Primary outcome
Proportion of participants who report ever having had a CRC screening test
Time frame: Baseline to 6 months
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.
2 secondary outcomes
Proportion of participants who are up-to-date for CRC screening
Time frame: At 6 months
Proportion of participants who intend to obtain CRC screening in the next 6 months
Time frame: At 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 29 Jul 2020.
- Individual participant dataSharing planned: No
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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 principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Informational Intervention and Survey Administration in people with Colorectal Carcinoma and Health Status Unknown, run by University of California, San Francisco at 4 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 8 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Proportion of participants who report ever having had a CRC screening test (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 29 Jul 2020.