TrialReader


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

NCT03115372 — Not applicable, Completed, 982 participants, University of California, San Francisco

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT03115372
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment982 (Actual)
SponsorUniversity of California, San Francisco (Other); collaborators: National Cancer Institute (NCI)
ConditionsColorectal Carcinoma, Health Status Unknown, Healthy Subject
InterventionsEducational Intervention, Informational Intervention, Survey Administration, Telephone-Based Intervention (Other, behavioral)
Datesstart 2012-02-01, primary completion 2015-07-01, completion 2015-09-01, first posted 2017-04-14, last updated 2020-07-29
Locations4 sites in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Colorectal Carcinoma All trials for Health Status Unknown All trials of Educational Intervention All trials of Informational Intervention

-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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Group I (CRC education)ExperimentalOther: Educational Intervention; Other: Survey Administration; Behavioral: Telephone-Based InterventionLHWs 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)Active comparatorOther: Educational Intervention; Other: Informational Intervention; Other: Survey Administration; Behavioral: Telephone-Based InterventionLHWs 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.
  • Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Attend CRC education session
  • Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Attend healthy nutrition session
  • Informational Intervention (Other): Receive CRC screening brochure
  • Survey Administration (Other): Ancillary studies
  • Telephone-Based Intervention (Behavioral): Receive telephone reminder about CRC screening
  • Telephone-Based Intervention (Behavioral): Receive telephone reminder about healthy nutrition

+Outcome measures

Primary outcomes

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

  • Proportion of participants who are up-to-date for CRC screening [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.
  • Proportion of participants who intend to obtain CRC screening in the next 6 months [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.

+Eligibility

Sex: All, ages: 50 Years to 75 Years, accepts healthy volunteers

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

+Locations (4)

FacilityCityCountryStatus
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CaliforniaUnited States
University of California Davis Comprehensive Cancer CenterSacramento, CaliforniaUnited States
University of California, San FranciscoSan Francisco, CaliforniaUnited States
University of Hawaii Cancer CenterHonolulu, HawaiiUnited States

+Investigators

  • Tung Nguyen, Principal investigator, University of California, San Francisco

+Funding

NIH grants: U54CA153499

My Notes