Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

Colorectal Neoplasms Clinical Trial

Official title:

Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947206
• Other study ID #: 1R01CA138778-01A1
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: May 6, 2014
• Start date: September 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 909
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• LHWO about CRC
2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt
• 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.

Locations

Country	Name	City	State
United States	NICOS	San Francisco	California
United States	San Francisco State University	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	NICOS Chinese Health Coalition, San Francisco State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Epub 2007 Feb 28. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ever had a CRC screening test		6 months	No
Secondary	up-to-date for CRC screening		6 months	No