Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVES: I. 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.

Official Title
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The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)

Conditions
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Colorectal Carcinoma, Health Status Unknown, Healthy Subject

Intervention / Treatment
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* Other: Educational Intervention
* Other: Educational Intervention
* Other: Informational Intervention
* Other: Survey Administration
* Behavioral: Telephone-Based Intervention
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Personal history of CRC Medical problems which may prevent them from attending 2 educational sessions

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (CRC education)<br>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. | Other: Educational Intervention<br>* Attend CRC education session<br>* Other names: Intervention, Educational;Other: Survey Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive telephone reminder about CRC screening<br>|
| Active Comparator: Group II (CRC brochure)<br>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. | Other: Educational Intervention<br>* Attend healthy nutrition session<br>* Other names: Intervention, Educational;Other: Informational Intervention<br>* Receive CRC screening brochure<br>Other: Survey Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive telephone reminder about healthy nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 6 months |