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

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298605
• Other study ID #: STUDY00001641
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Robert Haile, DrPH
• Phone: 310-423-5167
• Email: Robert.haile[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Kaiser Permanente Center for Health Equity	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	California Breast Cancer Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Participant knowledge, attitudes, and beliefs towards screening (Qualitative)	Assessed in qualitative interviews	up to 6 months
Secondary	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