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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05298605
Other study ID # STUDY00001641
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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