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

Primary Purpose

Colorectal Carcinoma, Health Status Unknown, Healthy Subject

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Educational Intervention
Informational Intervention
Survey Administration
Telephone-Based Intervention
Telephone-Based Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Carcinoma

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • University of California, San Francisco
  • University of Hawaii Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (CRC education)

Group II (CRC brochure)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 11, 2017
Last Updated
July 27, 2020
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03115372
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Health Status Unknown, Healthy Subject

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
982 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (CRC education)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (CRC brochure)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend CRC education session
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend healthy nutrition session
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive CRC screening brochure
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone reminder about CRC screening
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone reminder about healthy nutrition
Primary Outcome Measure Information:
Title
Proportion of participants who report ever having had a CRC screening test
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Proportion of participants who are up-to-date for CRC screening
Description
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.
Time Frame
At 6 months
Title
Proportion of participants who intend to obtain CRC screening in the next 6 months
Description
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.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung Nguyen
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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