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Clinical Trials/NCT05298605
NCT05298605
Recruiting
Not Applicable

Faith in Action! A Cluster-Randomized Trial to Evaluate the Efficacy of a Church-based Navigation Model to Increase Breast Cancer Screening Among Korean Women in Los Angeles

Cedars-Sinai Medical Center2 sites in 1 country320 target enrollmentJuly 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Cedars-Sinai Medical Center
Enrollment
320
Locations
2
Primary Endpoint
Screening adherence
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this research is to develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings and evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings in Los Angeles, California. The primary research procedures include trainings and key informant interviews with lay health navigators in faith-based settings followed by a cluster randomized trial to evaluate the intervention.

Detailed Description

A parallel cluster randomized trial (CRT) with staggered roll-out will be conducted to evaluate the efficacy of the "Faith in Action!" intervention on breast cancer screening rates among Korean American women. This will involve two blocks of 8 churches each (total 16 churches) randomized to either the intervention or waitlist control. A train the trainer approach will be used to educate and certify lay health navigators identified by targeted Korean church leaders from selected churches. The trained health navigators will be deployed back to the churches and community settings with tools and resources to deliver cancer education and increase motivation to participate in breast cancer screening through proven approaches such as one-on-one education, small media and workshops. The research objectives are to: 1. Develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings. 2. Evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings. It is hypothesized that the implementation of this culturally adapted cancer screening training curriculum for lay health navigators, built upon the Korean communities' frequent engagement with "expert" schools and deployed among existing networks in the faith-based Korean community, will increase adherence to breast cancer screening guidelines among underserved Korean American women.

Registry
clinicaltrials.gov
Start Date
July 16, 2022
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Haile

Director, Cancer Research Center for Health Equity, Professor, Department of Medicine, Associate Director for Population Health

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Korean woman who is 45 years or older
  • Does not currently have a breast cancer diagnosis
  • Non-adherent to cancer screening (did not receive mammogram in last 2 years based on self-report)
  • Prospective or current member of participating Korean Churches
  • Willing to participate in study

Exclusion Criteria

  • Does not meet inclusion criteria as described above

Outcomes

Primary Outcomes

Screening adherence

Time Frame: up to 6 months from end of program

Percent change in adherence to breast cancer screening guidelines within 6 months from end of program

Secondary Outcomes

  • Participant knowledge, attitudes, and beliefs towards screening (Qualitative)(up to 6 months)
  • Change in Knowledge of Breast Cancer Screening(up to 6 months)
  • Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)(up to 6 months)

Study Sites (2)

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