AANCART Research Project on Lay Health Workers and Asian Americans

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904890
• Other study ID #: U54CA153499 Sub7323
• Secondary ID: U54CA153499
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: December 29, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• CRC Prevention and Screening Education
Refer to Arm Description
• Nutrition Education
Refer to Arm Description

Locations

Country	Name	City	State
United States	University of Hawai`i at Manoa	Honolulu	Hawaii
United States	University of California Los Angeles	Los Angeles	California
United States	University of California Davis	Sacramento	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI), University of California, Davis, University of California, Los Angeles, University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of CRC Screening	self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy	Baseline to 6 months	No
Secondary	Up-to-date CRC screening receipt	self-report of FOBT within 12 months, sigmoidoscopy within 5 years, or colonoscopy within 10 years	Baseline to 6 months	No
Secondary	CRC screening Intention	self-report of intending to obtain CRC screening in 6 months	Baseline to 6 months	No