Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Health Knowledge, Attitudes, Practice; Breast Cancer Female; Health Disparities; Cancer Screening
• Intervention / Treatment: Behavioral: Faith in Action! Church-based Navigation Model; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Haile, DrPH; Phone Number: 310-423-5167; Email: Robert.haile@cshs.org
• Study Contact Backup: Name: Hayden Hutchison; Phone Number: 310-423-2361; Email: Hayden.Hutchison@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Robert Haile, DrPH
      • Sub-Investigator: Christie Jeon, ScD
      • Sub-Investigator: Gillian Gresham, PhD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Kaiser Permanente Center for Health Equity
      • Contact: Allison Herrmann, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Faith in Action!; A train-the-trainer approach will be used to educate lay health navigators to present the culturally adapted "Faith in Action!" curriculum and to provide breast cancer screening navigation to Korean American women within faith-based settings	Behavioral: Faith in Action! Church-based Navigation Model; Cancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet
Active Comparator: Control; A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups.	Other: Control; Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening adherence	Percent change in adherence to breast cancer screening guidelines within 6 months from end of program	up to 6 months from end of program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)	Assessed in validated, Breast Cancer Screening Beliefs Questionnaire (Kwok et al) including Likert-type questions (13 items and 3 sub scales, items range 1-5, strongly agree to strongly disagree)	up to 6 months
Participant knowledge, attitudes, and beliefs towards screening (Qualitative)	Assessed in qualitative interviews	up to 6 months
Change in Knowledge of Breast Cancer Screening	Knowledge of breast cancer screening based on pre-post knowledge assessments adapted Cancer 101 assessments (3 knowledge assessments (5 items each), response categories: Agree, Disagree, or Unsure).	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NIH PROMIS Global Health	Change in continuous NIH PROMIS converted T-Scores (mean 50, SD:10) at 6 months. Questionnaire includes physical and mental health domains (4 items total, likert 5-point scale, converted to continuous T scores)	Up to 6 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: California Breast Cancer Research Program

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY00001641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregated data at cluster level will be available upon reasonable request.
• IPD Sharing Time Frame: Within one year from end of study
• IPD Sharing Access Criteria: Published protocol and uploaded to ClinicalTrials.Gov.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No