NCT05298605

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

March 17, 2022

Last Update Submit

August 23, 2024

Conditions

Breast Cancer FemaleHealth Knowledge, Attitudes, PracticeCancer ScreeningHealth Disparities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)

    up to 6 months

  • Participant knowledge, attitudes, and beliefs towards screening (Qualitative)

    up to 6 months

  • Change in Knowledge of Breast Cancer Screening

    up to 6 months

Other Outcomes (1)

  • Change in NIH PROMIS Global Health

    Up to 6 months

Study Arms (2)

Faith in Action!

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups.

Other: Control

Interventions

Faith in Action! Church-based Navigation ModelBEHAVIORAL

Cancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet

Faith in Action!
ControlOTHER

Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet

Control

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen at risk of breast cancer
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

RECRUITING

UCLA Kaiser Permanente Center for Health Equity

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

  • Gresham G, Kim DH, Sung MJ, Diniz MA, Finster L, Fine M, Jeon C, Herrmann AK, Lee JY, Surani Z, Haile RW. Protocol for a cluster randomized trial to evaluate a faith-based breast cancer screening navigation model. Trials. 2026 Jan 29. doi: 10.1186/s13063-025-09397-2. Online ahead of print.

    PMID: 41612469DERIVED

MeSH Terms

Conditions

Behavior

Central Study Contacts

Robert Haile, DrPH

CONTACT

310-423-5167Robert.haile@cshs.org

Hayden Hutchison

CONTACT

310-423-2361Hayden.Hutchison@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cancer Research Center for Health Equity, Professor, Department of Medicine, Associate Director for Population Health

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

July 16, 2022

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Aggregated data at cluster level will be available upon reasonable request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Within one year from end of study
Access Criteria
Published protocol and uploaded to ClinicalTrials.Gov.

Locations

US(2)