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Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LHWO about CRC
Nutrition Education + CRC brochure
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 Neoplasms focused on measuring Chinese Americans, lay health worker outreach, colorectal cancer screening

Eligibility Criteria

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

Inclusion Criteria:

  • self-identified as Chinese or Chinese Americans
  • age 50 to 75
  • speak a language that the LHW can speak (Cantonese, Mandarin, and/or English)
  • live and intend to stay in SF for at least 12 months
  • have no personal history of CRC
  • have no medical problems preventing them from attending educational sessions
  • willing to participate in a study about health behaviors involving nutrition or CRC screening

Exclusion Criteria:

  • anyone who does not meet the above criteria
  • those unable to understand informed consent form written in their language
  • those too debilitated to attend educational sessions

Sites / Locations

  • NICOS
  • San Francisco State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LHWO about CRC

Nutrition education + CRC brochure

Arm Description

The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt.

The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.

Outcomes

Primary Outcome Measures

ever had a CRC screening test

Secondary Outcome Measures

up-to-date for CRC screening

Full Information

First Posted
July 24, 2009
Last Updated
May 6, 2014
Sponsor
University of California, San Francisco
Collaborators
San Francisco State University, NICOS Chinese Health Coalition
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1. Study Identification

Unique Protocol Identification Number
NCT00947206
Brief Title
Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans
Official Title
Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco State University, NICOS Chinese Health Coalition

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposed project seeks to expand understanding of what constitutes a "lay health worker (LHW)," how those characteristics determine the effectiveness of LHWs as health educators on colorectal cancer (CRC) screening, and the relationship of those characteristics to a particular community and culture. 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 Chinese Americans age 50 to 75 with a pilot component to evaluate the role of Traditional Chinese Medicine (TCM) healers as health educators. The investigators will conduct focus groups with community participants to revise training materials developed in a prior pilot project. The investigators will also conduct ethnographic observations of TCM healers and focus groups with their clients to refine the training materials. The investigators will recruit 26 LHWs to be assigned to the intervention arm and 26 to the comparison arm. The LHWs will each recruit 12 participants from their social network for a total of 312 participants in each arm. The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt. The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors, with validation of self-reports. An additional 10 TCM healers will also participate as LHWs. They will each recruit 12 participants for LHWO. There will be extensive ethnographic observations as well as post-intervention focus groups of LHWO activities, LHWs, and LHWO participants to assess the factors that contribute to effective LHWO. The primary hypothesis is that the increase in the proportion of participants who report ever having had a CRC screening test in the experimental group (LHWO about CRC) will be greater than the increase in the comparison group (nutrition education + CRC brochure).
Detailed Description
The secondary hypotheses are: The increase in the proportion of participants who are up-to-date for CRC screening in the experimental group will be greater than the increase in the comparison group; The increase in the proportion of participants who intend to obtain CRC screening in the next 6 months in the experimental group will be greater than the increase in the comparison group; The increase in the proportion of participants who are aware of CRC screening tests in the experimental group will be greater than the increase in the comparison group; Self-efficacy is a mediator between intervention and receipt of CRC screening. Knowledge is a mediator between intervention and receipt of CRC screening. Gender is a moderator between intervention and receipt of CRC screening. Although the pilot project intervention was effective in both men and women, the sample was too small to determine if there was a gender effect. Based on the extensive literature on LHWO among women, the intervention may be more effective among women than men. Additional secondary hypotheses will apply the primary hypothesis and secondary hypotheses 1-3 to individual CRC tests (FOBT, sigmoidoscopy, or colonoscopy) rather than to the combined outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Chinese Americans, lay health worker outreach, colorectal cancer screening

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LHWO about CRC
Arm Type
Experimental
Arm Description
The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt.
Arm Title
Nutrition education + CRC brochure
Arm Type
Active Comparator
Arm Description
The comparison group will receive a bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.
Intervention Type
Behavioral
Intervention Name(s)
LHWO about CRC
Intervention Description
2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education + CRC brochure
Intervention Description
Bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.
Primary Outcome Measure Information:
Title
ever had a CRC screening test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
up-to-date for CRC screening
Time Frame
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: self-identified as Chinese or Chinese Americans age 50 to 75 speak a language that the LHW can speak (Cantonese, Mandarin, and/or English) live and intend to stay in SF for at least 12 months have no personal history of CRC have no medical problems preventing them from attending educational sessions willing to participate in a study about health behaviors involving nutrition or CRC screening Exclusion Criteria: anyone who does not meet the above criteria those unable to understand informed consent form written in their language those too debilitated to attend educational sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung T Nguyen, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICOS
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
San Francisco State University
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16276538
Citation
Wong ST, Gildengorin G, Nguyen T, Mock J. Disparities in colorectal cancer screening rates among Asian Americans and non-Latino whites. Cancer. 2005 Dec 15;104(12 Suppl):2940-7. doi: 10.1002/cncr.21521.
Results Reference
background
PubMed Identifier
17329652
Citation
Mock J, McPhee SJ, Nguyen T, Wong C, Doan H, Lai KQ, Nguyen KH, Nguyen TT, Bui-Tong N. Effective lay health worker outreach and media-based education for promoting cervical cancer screening among Vietnamese American women. Am J Public Health. 2007 Sep;97(9):1693-700. doi: 10.2105/AJPH.2006.086470. Epub 2007 Feb 28.
Results Reference
background
PubMed Identifier
17323211
Citation
Wu AP, Burke A, LeBaron S. Use of traditional medicine by immigrant Chinese patients. Fam Med. 2007 Mar;39(3):195-200.
Results Reference
background
PubMed Identifier
20204570
Citation
Nguyen TT, Love MB, Liang C, Fung LC, Nguyen T, Wong C, Gildengorin G, Woo K. A pilot study of lay health worker outreach and colorectal cancer screening among Chinese Americans. J Cancer Educ. 2010 Sep;25(3):405-12. doi: 10.1007/s13187-010-0064-3. Epub 2010 Mar 5.
Results Reference
background
PubMed Identifier
27986352
Citation
Nguyen TT, Tsoh JY, Woo K, Stewart SL, Le GM, Burke A, Gildengorin G, Pasick RJ, Wang J, Chan E, Fung LC, Jih J, McPhee SJ. Colorectal Cancer Screening and Chinese Americans: Efficacy of Lay Health Worker Outreach and Print Materials. Am J Prev Med. 2017 Mar;52(3):e67-e76. doi: 10.1016/j.amepre.2016.10.003. Epub 2016 Dec 13.
Results Reference
derived

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Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

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