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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | California Breast Cancer Research Program |
United States,
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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