search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRC Prevention and Screening Education
Nutrition Education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Asian Americans, colorectal cancer screening, cancer prevention, Filipinos Americans, Hmong Americans, Korean Americans, Randomized Controlled Trials

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Los Angeles
  • University of California Davis
  • University of Hawai'i at Manoa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRC Prevention and Screening Education

Nutrition Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Up-to-date CRC screening receipt
self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years
CRC screening Intention
self-report of intending to obtain CRC screening in 6 months

Full Information

First Posted
July 10, 2013
Last Updated
December 29, 2015
Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, University of California, Los Angeles, University of Hawaii, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01904890
Brief Title
AANCART Research Project on Lay Health Workers and Asian Americans
Acronym
AANCARTLHW
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, University of California, Los Angeles, University of Hawaii, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Asian Americans, colorectal cancer screening, cancer prevention, Filipinos Americans, Hmong Americans, Korean Americans, Randomized Controlled Trials

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
994 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRC Prevention and Screening Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
CRC Prevention and Screening Education
Intervention Description
Refer to Arm Description
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Refer to Arm Description
Primary Outcome Measure Information:
Title
Receipt of CRC Screening
Description
self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Up-to-date CRC screening receipt
Description
self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years
Time Frame
Baseline to 6 months
Title
CRC screening Intention
Description
self-report of intending to obtain CRC screening in 6 months
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung Nguyen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Hawai'i at Manoa
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States

12. IPD Sharing Statement

Learn more about this trial

AANCART Research Project on Lay Health Workers and Asian Americans

We'll reach out to this number within 24 hrs