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Clinical Trials/NCT03115372
NCT03115372CompletedNot Applicable

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

University of California, San Francisco8 sites in 1 country982 target enrollmentStarted: February 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
982
Locations
8
Primary Endpoint
Proportion of participants who report ever having had a CRC screening test

Study Overview

Brief 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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Proportion of participants who are up-to-date for CRC screening(At 6 months)
  • Proportion of participants who intend to obtain CRC screening in the next 6 months(At 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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