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AANCART Research Project on Lay Health Workers and Asian Americans (AANCARTLHW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborators:
University of California, Davis
University of California, Los Angeles
University of Hawaii
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01904890
First received: July 10, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer Screening
Behavioral: CRC Prevention and Screening Education
Behavioral: Nutrition Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Asian American Network for Cancer Awareness, Research, and Training (AANCART): The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Receipt of CRC Screening [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy


Secondary Outcome Measures:
  • Up-to-date CRC screening receipt [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years

  • CRC screening Intention [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    self-report of intending to obtain CRC screening in 6 months


Estimated Enrollment: 1008
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • personal history of CRC
  • medical problems which may prevent them from attending 2 educational sessions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904890

Contacts
Contact: Ching Wong, BS (415) 502-4099 ching.wong@ucsf.edu
Contact: Tung Nguyen, MD 415-514-8659 tung.nguyen@ucsf.edu

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Marjorie Kagawa Singer, PhD    310.794.6604    mkagawa@ucla.edu   
Principal Investigator: Marjorie Kagawa Singer, PhD, MA, MN, RN, FAAN         
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Elisa Tong, MD, MA    916-734-7005    elisa.tong@ucdmc.ucdavis.edu   
Sub-Investigator: Elisa Tong, MD, MA         
United States, Hawaii
University of Hawai`i at Manoa Recruiting
Honolulu, Hawaii, United States, 96822
Contact: Angela Sy, DrPH    808-956-5181    sya@hawaii.edu   
Principal Investigator: Angela Sy, DrPH         
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
University of California, Los Angeles
University of Hawaii
Investigators
Principal Investigator: Tung Nguyen, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01904890     History of Changes
Other Study ID Numbers: U54CA153499 Sub7323, U54CA153499
Study First Received: July 10, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Asian Americans
colorectal cancer screening
cancer prevention
Filipinos Americans
Hmong Americans
Korean Americans
Randomized Controlled Trials

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014