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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Carcinoma; Healthy Subject; Health Status Unknown
• Intervention / Treatment: Other: Survey Administration; Other: Educational Intervention; Other: Educational Intervention; Behavioral: Telephone-Based Intervention; Behavioral: Telephone-Based Intervention; Other: Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 982
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Attend CRC education session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Attend healthy nutrition session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Telephone-Based Intervention; Receive telephone reminder about CRC screening; Behavioral: Telephone-Based Intervention; Receive telephone reminder about healthy nutrition
Active Comparator: 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.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Attend CRC education session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Attend healthy nutrition session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Telephone-Based Intervention; Receive telephone reminder about CRC screening; Behavioral: Telephone-Based Intervention; Receive telephone reminder about healthy nutrition; Other: Informational Intervention; Receive CRC screening brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tung Nguyen, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 11056 (DAIDS ES Registry Number); U54CA153499 (U.S. NIH Grant/Contract); NCI-2017-00515 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No