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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT03115372
Collaborator
National Cancer Institute (NCI) (NIH)
982
Enrollment
4
Locations
2
Arms
43
Actual Duration (Months)
245.5
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Educational Intervention
  • Other: Informational Intervention
  • Other: Survey Administration
  • Behavioral: Telephone-Based Intervention
  • Behavioral: Telephone-Based Intervention
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

  2. 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

Study Type:
Interventional
Actual Enrollment :
982 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
Actual Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Educational Intervention
Attend CRC education session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Survey Administration
    Ancillary studies

    Behavioral: Telephone-Based Intervention
    Receive telephone reminder about CRC screening
    Active Comparator: 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.

    Other: Educational Intervention
    Attend healthy nutrition session
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Informational Intervention
    Receive CRC screening brochure

    Other: Survey Administration
    Ancillary studies

    Behavioral: Telephone-Based Intervention
    Receive telephone reminder about healthy nutrition

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who report ever having had a CRC screening test [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 Outcome Measures

    1. Proportion of participants who are up-to-date for CRC screening [At 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.

    2. Proportion of participants who intend to obtain CRC screening in the next 6 months [At 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    2 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    3 University of California, San Francisco San Francisco California United States 94115
    4 University of Hawaii Cancer Center Honolulu Hawaii United States 96813

    Sponsors and Collaborators

    • University of California, San Francisco
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Tung Nguyen, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03115372
    Other Study ID Numbers:
    • 11056
    • NCI-2017-00515
    • U54CA153499
    First Posted:
    Apr 14, 2017
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jul 29, 2020