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Completed

NCT Number: NCT03115372

Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans

This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Status Unknown Healthy Subject 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

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).

II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.

OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.

GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.

GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.

After completion of the study, patients are followed up at 2 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • LHW: self-identified as Filipino, Hmong, or Korean Americans
  • LHW: age 18 or older
  • LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
  • LHW: Live in the relevant area and intend to stay there for the next 12 months
  • PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
  • PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
  • PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
  • PARTICIPANTS: Are willing to participate in a study about health behaviors involving nutrition or CRC screening

Exclusion criteria

  • Personal history of CRC
  • Medical problems which may prevent them from attending 2 educational sessions

Treatment and study plan

Educational Intervention

Other

Attend CRC education session

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Informational intervention

Other

Receive CRC screening brochure

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive telephone reminder about CRC screening

Primary outcomes

  1. Proportion of participants who report ever having had a CRC screening test

    Time frame: Baseline to 6 months

    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.

Secondary outcomes

  1. Proportion of participants who are up-to-date for CRC screening

    Time frame: At 6 months

    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.

  2. Proportion of participants who intend to obtain CRC screening in the next 6 months

    Time frame: At 6 months

    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2017
Registry last updated
Jul 29, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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