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

NCT03115372 | Completed DMC

• 3 other identifiers: 11056NCI-2017-00515U54CA153499
• Study Type: interventional
• Target: 982
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Colorectal Carcinoma; Health Status Unknown; Healthy Subject

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to 6 months

Secondary Outcomes (2)

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

  At 6 months

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

  At 6 months

Study Arms (2)

Group I (CRC education)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Group II (CRC brochure)

ACTIVE COMPARATOR

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.

Other: Educational Intervention; Other: Informational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Interventions

Educational Intervention OTHER

Attend CRC education session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (CRC education)

Informational Intervention OTHER

Receive CRC screening brochure

Group II (CRC brochure)

Survey Administration OTHER

Ancillary studies

Group I (CRC education); Group II (CRC brochure)

Telephone-Based Intervention BEHAVIORAL

Receive telephone reminder about CRC screening

Group I (CRC education)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Tung Nguyen

  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: April 11, 2017
• First Posted: April 14, 2017
• Study Start: February 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)