search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Faith in Action! Church-based Navigation Model
Control
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Female

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting
  • UCLA Kaiser Permanente Center for Health EquityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faith in Action!

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Participant knowledge, attitudes, and beliefs towards screening (Qualitative)
Assessed in qualitative interviews
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).

Full Information

First Posted
March 17, 2022
Last Updated
July 18, 2022
Sponsor
Cedars-Sinai Medical Center
Collaborators
California Breast Cancer Research Program
search

1. Study Identification

Unique Protocol Identification Number
NCT05298605
Brief Title
Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
California Breast Cancer Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Health Knowledge, Attitudes, Practice, Cancer Screening, Health Disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Faith in Action!
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups.
Intervention Type
Behavioral
Intervention Name(s)
Faith in Action! Church-based Navigation Model
Intervention Description
Cancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet
Primary Outcome Measure Information:
Title
Screening adherence
Description
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 Outcome Measure Information:
Title
Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)
Description
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
Title
Participant knowledge, attitudes, and beliefs towards screening (Qualitative)
Description
Assessed in qualitative interviews
Time Frame
up to 6 months
Title
Change in Knowledge of Breast Cancer Screening
Description
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 Pre-specified Outcome Measures:
Title
Change in NIH PROMIS Global Health
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women at risk of breast cancer
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Haile, DrPH
Phone
310-423-5167
Email
Robert.haile@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Hayden Hutchison
Phone
310-423-2361
Email
Hayden.Hutchison@cshs.org
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Haile, DrPH
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
First Name & Middle Initial & Last Name & Degree
Christie Jeon, ScD
Facility Name
UCLA Kaiser Permanente Center for Health Equity
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Herrmann, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs