Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans

Colorectal Carcinoma Clinical Trial

Official title:

The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115372
• Other study ID #: 11056
• Secondary ID: NCI-2017-00515U5
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: September 1, 2015

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 982
• Est. completion date: September 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Health Status Unknown
• Healthy Subject

Intervention

Other:
• Educational Intervention
Attend CRC education session
• Educational Intervention
Attend healthy nutrition session
• Informational Intervention
Receive CRC screening brochure
• Survey Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone reminder about CRC screening
• Telephone-Based Intervention
Receive telephone reminder about healthy nutrition

Locations

Country	Name	City	State
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who report ever having had a CRC screening test	Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.	Baseline to 6 months
Secondary	Proportion of participants who are up-to-date for CRC screening	Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.	At 6 months
Secondary	Proportion of participants who intend to obtain CRC screening in the next 6 months	Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.	At 6 months