ClinicalTrials.gg
Status unknownNCT05298605Updated Aug 27, 2024

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

An interventional study of Faith in Action! Church-based Navigation Model and Control in Breast Cancer Female, Health Knowledge, Attitudes, Practice and Cancer Screening, sponsored by Cedars-Sinai Medical Center. Status unknown at 2 sites in United States. Open to female participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer Female
  • Health Knowledge, Attitudes, Practice
  • Cancer Screening
  • Health Disparities

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03

In context

Behavior

406 studies on the registry are indexed under Behavior; 167 are open to participants now.

This study's planned enrollment of 320 is above the median of 120 across 316 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Does not meet inclusion criteria as described above
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
320 participants (estimated)

Study arms

  • 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

  • Active comparator
    Control

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

    Other: Control

Interventions

  • BehavioralFaith 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

  • OtherControl

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

06

What researchers measure

Primary outcomes

  1. Screening adherence

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

    Time frame: up to 6 months from end of program

Secondary outcomes

  1. 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)

    Time frame: up to 6 months

  2. Participant knowledge, attitudes, and beliefs towards screening (Qualitative)

    Assessed in qualitative interviews

    Time frame: up to 6 months

  3. 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).

    Time frame: up to 6 months

Other outcomes

  1. 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)

    Time frame: Up to 6 months

07

Study locations

2 of 2 sites recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California 90069, United States
    • Robert Haile, DrPH · Contact
    • Gillian Gresham, PhD · Sub investigator
    • Christie Jeon, ScD · Sub investigator
    Recruiting
  • UCLA Kaiser Permanente Center for Health Equity
    Los Angeles, California 90095, United States
    • Allison Herrmann, PhD · Contact
    Recruiting
08

References and documents

Publications

  • 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;27(1):168. doi: 10.1186/s13063-025-09397-2. PubMed 41612469 ↗

Individual participant data

Plan to share: Yes — Aggregated data at cluster level will be available upon reasonable request.

Supporting information: Study protocol, Informed consent form

Time frame: Within one year from end of study

Access criteria: Published protocol and uploaded to ClinicalTrials.Gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05298605
Collaborators
California Breast Cancer Research Program
Responsible party
Robert Haile (Director, Cancer Research Center for Health Equity, Professor, Department of Medicine, Associate Director for Population Health, Cedars-Sinai Medical Center) — Principal investigator
First posted
Mar 28, 2022
Start date
Jul 16, 2022
Primary completion
Jul 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Aug 27, 2024

Study contacts

Robert Haile, DrPH
Contact
Robert.haile@cshs.org
310-423-5167
Hayden Hutchison
Contact
Hayden.Hutchison@cshs.org
310-423-2361

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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