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

• ClinicalTrials.gov Identifier: NCT01904890
• Recruitment Status: Completed
• First Posted: July 22, 2013
• Last Update Posted: December 30, 2015
• Sponsor: University of California, San Francisco
• 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

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• Principal Investigator: Tung Nguyen, MD; University of California, San Francisco

More Information

• 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
• 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:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases