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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

Tracking Information
First Submitted Date  ICMJE July 10, 2013
First Posted Date  ICMJE July 22, 2013
Last Update Posted Date December 30, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Receipt of CRC Screening [ Time Frame: Baseline to 6 months ]
self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • 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
  • CRC screening Intention [ Time Frame: Baseline to 6 months ]
    self-report of intending to obtain CRC screening in 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AANCART Research Project on Lay Health Workers and Asian Americans
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Behavioral: CRC Prevention and Screening Education
    Refer to Arm Description
  • Behavioral: Nutrition Education
    Refer to Arm Description
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Nutrition Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2015)
994
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2013)
1008
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01904890
Other Study ID Numbers  ICMJE U54CA153499 Sub7323
U54CA153499 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of California, Davis
  • University of California, Los Angeles
  • University of Hawaii
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Tung Nguyen, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP