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

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ClinicalTrials.gov Identifier: NCT01904890
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 30, 2015
Sponsor:
Collaborators:
University of California, Davis
University of California, Los Angeles
University of Hawaii
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: CRC Prevention and Screening Education Behavioral: Nutrition Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 994 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Refer to Arm Description
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
Refer to Arm Description


Outcome Measures
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Primary Outcome Measures :
  1. Receipt of CRC Screening [ Time Frame: Baseline to 6 months ]
    self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy


Secondary Outcome Measures :
  1. Up-to-date CRC screening receipt [ Time Frame: Baseline to 6 months ]
    self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years

  2. CRC screening Intention [ Time Frame: Baseline to 6 months ]
    self-report of intending to obtain CRC screening in 6 months


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904890


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
University of California Davis
Sacramento, California, United States, 95817
United States, Hawaii
University of Hawai'i at Manoa
Honolulu, Hawaii, United States, 96822
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
University of California, Los Angeles
University of Hawaii
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tung Nguyen, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01904890    
Other Study ID Numbers: U54CA153499 Sub7323
U54CA153499 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases