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Completed

NCT Number: NCT00947206

Lay Health Workers and Colorectal Cancer Screening Among Chinese Americans

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).

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICOS, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LHWO about CRC

Behavioral

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

Nutrition Education + CRC brochure

Behavioral

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

Primary outcomes

  1. ever had a CRC screening test

    Time frame: 6 months

Secondary outcomes

  1. up-to-date for CRC screening

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • NICOS Chinese Health Coalition
  • San Francisco State University

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2009
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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