NCT00947206

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
909

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

4.7 years

First QC Date

July 24, 2009

Last Update Submit

May 6, 2014

Conditions

Keywords

Chinese Americanslay health worker outreachcolorectal cancer screening

Outcome Measures

Primary Outcomes (1)

  • ever had a CRC screening test

    6 months

Secondary Outcomes (1)

  • up-to-date for CRC screening

    6 months

Study Arms (2)

LHWO about CRC

EXPERIMENTAL

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

Nutrition education + CRC brochure

ACTIVE COMPARATOR

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

Interventions

LHWO about CRCBEHAVIORAL

2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt

LHWO about CRC

Bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.

Nutrition education + CRC brochure

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NICOS

San Francisco, California, 94108, United States

Location

San Francisco State University

San Francisco, California, 94132, United States

Location

Related Publications (5)

  • 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.

    PMID: 16276538BACKGROUND
  • 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.

    PMID: 17329652BACKGROUND
  • Wu AP, Burke A, LeBaron S. Use of traditional medicine by immigrant Chinese patients. Fam Med. 2007 Mar;39(3):195-200.

    PMID: 17323211BACKGROUND
  • 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.

    PMID: 20204570BACKGROUND
  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Tung T Nguyen, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 28, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations