Clinical trial NCT03115372: Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans
Official title: The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Health Status Unknown
Healthy Subject
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-14
Enrollment: 982
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).

II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.

OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.

GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.

GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.

After completion of the study, patients are followed up at 2 months.

Eligibility criteria: Inclusion Criteria:

* LHW: self-identified as Filipino, Hmong, or Korean Americans
* LHW: age 18 or older
* LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
* LHW: Live in the relevant area and intend to stay there for the next 12 months
* PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
* PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
* PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
* PARTICIPANTS: 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

Primary outcomes:
measure: Proportion of participants who report ever having had a CRC screening test
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Proportion of participants who are up-to-date for CRC screening
timeFrame: At 6 months
measure: Proportion of participants who intend to obtain CRC screening in the next 6 months
timeFrame: At 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: University of California, San Francisco
name: Tung Nguyen
role: PRINCIPAL_INVESTIGATOR
References: