Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

This study is currently recruiting participants.
Verified September 2013 by University of California, San Francisco
Sponsor:
Collaborators:
San Francisco State University
NICOS Chinese Health Coalition
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00947206
First received: July 24, 2009
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Colorectal Neoplasms
Behavioral: LHWO about CRC
Behavioral: Nutrition Education + CRC brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • ever had a CRC screening test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • up-to-date for CRC screening [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 784
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LHWO about CRC
The intervention group participants will be exposed to 2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt.
Behavioral: LHWO about CRC
2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt
Active Comparator: Nutrition education + CRC brochure
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.
Behavioral: Nutrition Education + CRC brochure
Bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.

Detailed Description:

The secondary hypotheses are:

  1. 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;
  2. 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;
  3. 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;
  4. Self-efficacy is a mediator between intervention and receipt of CRC screening.
  5. Knowledge is a mediator between intervention and receipt of CRC screening.
  6. 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947206

Contacts
Contact: Tung T Nguyen, MD 415-514-8659 tung.nguyen@ucsf.edu
Contact: Gem M Le, PhD 415-476-0101 gem.le@ucsf.edu

Locations
United States, California
NICOS Recruiting
San Francisco, California, United States, 94108
Contact: Kent Woo, MSW    415-788-6426    KentWoo@aol.com   
Principal Investigator: Kent Woo, MSW         
San Francisco State University Not yet recruiting
San Francisco, California, United States, 94132
Contact: Adam Burke, PhD    415-338-1774    aburke@sfsu.edu   
Contact: Jun Wang, PhD    415-405-2147    wangjun@sfsu.edu   
Sub-Investigator: Jun Wang, PhD         
Sub-Investigator: Adam Burke, PhD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco State University
NICOS Chinese Health Coalition
Investigators
Principal Investigator: Tung T Nguyen, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00947206     History of Changes
Other Study ID Numbers: 1R01CA138778-01A1
Study First Received: July 24, 2009
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Chinese Americans
lay health worker outreach
colorectal cancer screening

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 15, 2014