NCT01904890

Brief Summary

This is a behavioral research study to evaluate the effectiveness of a type of health education, lay health worker (LHWs), on increasing the use of a routine health behavior, colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening. 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 Asian Americans age 50 to 75. The investigators will conduct focus groups and individual interviews with community participants to revise training and survey materials developed in prior projects. The investigators will recruit LHWs to be randomly assigned to the intervention arm and to the comparison arm. The LHWs will each recruit 15 participants from their social network. Intervention LHWs will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach session on CRC screening. Effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' CRC screening behaviors. The investigators will also conduct ethnographic observations of LHWs and their participants during the small group sessions and post- intervention focus groups to understand how such a health education approach may work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
994

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.4 years

First QC Date

July 10, 2013

Last Update Submit

December 29, 2015

Conditions

Keywords

Asian Americanscolorectal cancer screeningcancer preventionFilipinos AmericansHmong AmericansKorean AmericansRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • Receipt of CRC Screening

    self-report of ever had fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy

    Baseline to 6 months

Secondary Outcomes (2)

  • Up-to-date CRC screening receipt

    Baseline to 6 months

  • CRC screening Intention

    Baseline to 6 months

Study Arms (2)

CRC Prevention and Screening Education

EXPERIMENTAL

Intervention Lay Health Workers (LHWs) will be taught to teach their participants about CRC screening through 2 outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt.

Behavioral: CRC Prevention and Screening Education

Nutrition Education

ACTIVE COMPARATOR

LHWs and participants in the comparison group will receive a bilingual CRC brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention LHW outreach session on CRC screening.

Behavioral: Nutrition Education

Interventions

Refer to Arm Description

CRC Prevention and Screening Education

Refer to Arm Description

Nutrition Education

Eligibility Criteria

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

You may qualify if:

  • self-identified as Filipino, Hmong, or Korean Americans
  • age 50 to 75
  • speak a language that the lay health worker (LHW) can speak such as Tagalog, Ilocano, Hmong, Korean, or English
  • live in relevant area and intend to stay there for at least 12 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University of Hawai'i at Manoa

Honolulu, Hawaii, 96822, United States

Location

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 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 10, 2013

First Posted

July 22, 2013

Study Start

March 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations