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CompletedNCT01904890AANCARTLHWUpdated Dec 30, 2015

AANCART Research Project on Lay Health Workers and Asian Americans

An interventional study of CRC Prevention and Screening Education and Nutrition Education in Colorectal Cancer, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
994
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Asian Americans
  • colorectal cancer screening
  • cancer prevention
  • Filipinos Americans
  • Hmong Americans
  • Korean Americans
  • Randomized Controlled Trials
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 994 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • personal history of CRC
  • medical problems which may prevent them from attending 2 educational sessions
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
994 participants (actual)

Study arms

  • Experimental
    CRC Prevention and Screening Education

    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.

    Behavioral: CRC Prevention and Screening Education

  • Active comparator
    Nutrition Education

    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.

    Behavioral: Nutrition Education

Interventions

  • BehavioralCRC Prevention and Screening Education

    Refer to Arm Description

  • BehavioralNutrition Education

    Refer to Arm Description

06

What researchers measure

Primary outcomes

  1. Receipt of CRC Screening

    self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Up-to-date CRC screening receipt

    self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years

    Time frame: Baseline to 6 months

  2. CRC screening Intention

    self-report of intending to obtain CRC screening in 6 months

    Time frame: Baseline to 6 months

07

Study locations

3 sites
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • University of California Davis
    Sacramento, California 95817, United States
  • University of Hawai'i at Manoa
    Honolulu, Hawaii 96822, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01904890
Lead sponsor
University of California, San Francisco
Collaborators
University of California, Davis, University of California, Los Angeles, University of Hawaii, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 22, 2013
Start date
Mar 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Dec 30, 2015

Study contacts

Tung Nguyen, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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