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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05298605
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by (Responsible Party):
Robert Haile, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Health Knowledge, Attitudes, Practice Cancer Screening Health Disparities Behavioral: Faith in Action! Church-based Navigation Model Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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
Actual Study Start Date : July 16, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Active Comparator: Control
A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups.
Other: Control
Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet




Primary Outcome Measures :
  1. Screening adherence [ Time Frame: up to 6 months from end of program ]
    Percent change in adherence to breast cancer screening guidelines within 6 months from end of program


Secondary Outcome Measures :
  1. Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk) [ Time Frame: up to 6 months ]
    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)

  2. Participant knowledge, attitudes, and beliefs towards screening (Qualitative) [ Time Frame: up to 6 months ]
    Assessed in qualitative interviews

  3. Change in Knowledge of Breast Cancer Screening [ Time Frame: up to 6 months ]
    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).


Other Outcome Measures:
  1. Change in NIH PROMIS Global Health [ Time Frame: Up to 6 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women at risk of breast cancer
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05298605


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

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90069
Contact: Robert Haile, DrPH         
Sub-Investigator: Gillian Gresham, PhD         
Sub-Investigator: Christie Jeon, ScD         
UCLA Kaiser Permanente Center for Health Equity Recruiting
Los Angeles, California, United States, 90095
Contact: Allison Herrmann, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
California Breast Cancer Research Program
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Responsible Party: Robert Haile, Director, Cancer Research Center for Health Equity, Professor, Department of Medicine, Associate Director for Population Health, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05298605    
Other Study ID Numbers: STUDY00001641
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregated data at cluster level will be available upon reasonable request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Within one year from end of study
Access Criteria: Published protocol and uploaded to ClinicalTrials.Gov.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases