Breast Cancer FemaleNCT05298605
Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women
A study testing Faith in Action! Church-based Navigation Model in people with Breast Cancer Female and Health Knowledge, Attitudes, Practice, run by Cedars-Sinai Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Health Knowledge, Attitudes, Practice, Cancer Screening
- What is being tested?
- Faith in Action! Church-based Navigation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria as described above
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90069
Robert Haile, DrPH
Gillian Gresham, PhD
- Recruiting
UCLA Kaiser Permanente Center for Health Equity
Los Angeles, California, 90095
Allison Herrmann, PhD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer Female, Health Knowledge, Attitudes, Practice, Cancer Screening, Health Disparities
- Being tested
- Faith in Action! Church-based Navigation Model, Control
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith in Action! Church-based Navigation ModelBehavioural
Cancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet
ControlOther
Presentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Faith in Action! | Experimental | 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 Receives: Behavioral: Faith in Action! Church-based Navigation Model |
| Control | Active comparator | A presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening adherence
Percent change in adherence to breast cancer screening guidelines within 6 months from end of program
Measured: up to 6 months from end of program
Secondary outcomes (3)
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)
Measured: up to 6 months
Participant knowledge, attitudes, and beliefs towards screening (Qualitative)
Assessed in qualitative interviews
Measured: up to 6 months
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).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start16 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Responsible party
- Principal investigator, Robert Haile, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298605
- Sponsor's protocol ID
- STUDY00001641
- Status last verified
- Aug 2024
- First submitted
- 17 Mar 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data at cluster level will be available upon reasonable request.
Publications
Gresham G, Kim DH, Sung MJ, Diniz MA, Finster L, Fine M, Jeon C, Herrmann AK, Lee JY, Surani Z, Haile RW. Protocol for a cluster randomized trial to evaluate a faith-based breast cancer screening navigation model. Trials. 2026 Jan 29;27(1):168. doi: 10.1186/s13063-025-09397-2.
PubMed 41612469
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05298605
- Acronym / sponsor ID
- STUDY00001641
- Conditions
- Breast Cancer Female, Health Knowledge, Attitudes, Practice, Cancer Screening, Health Disparities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faith in Action! | Experimental | Behavioral: Faith in Action! Church-based Navigation ModelA 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 |
| Control | Active comparator | Other: ControlA presentation of lifestyle recommendations (e.g., physical activity, nutrition) will be provided to control groups. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria as described above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faith in Action! Church-based Navigation ModelCancer screening education and navigation by identified trained navigators in faith based settings + American Cancer Society Screening Guidelines pamphlet | Behavioural | Faith in Action! |
| ControlPresentation on healthy behaviors (physical activity, nutrition) + American Cancer Society Screening Guidelines pamphlet | Other | Control |
Primary outcome
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
3 secondary outcomes
Breast Cancer Screening Beliefs (Knowledge, Perception, and perceived risk)
Time frame: up to 6 months
Participant knowledge, attitudes, and beliefs towards screening (Qualitative)
Time frame: up to 6 months
Change in Knowledge of Breast Cancer Screening
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 41612469Gresham G, Kim DH, Sung MJ, Diniz MA, Finster L, Fine M, Jeon C, Herrmann AK, Lee JY, Surani Z, Haile RW. Protocol for a cluster randomized trial to evaluate a faith-based breast cancer screening navigation model. Trials. 2026 Jan 29;27(1):168. doi: 10.1186/s13063-025-09397-2.
- Individual participant dataSharing planned: Yes. Aggregated data at cluster level will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith in Action! Church-based Navigation Model in people with Breast Cancer Female and Health Knowledge, Attitudes, Practice, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Haile, DrPH (310-423-5167, Robert.haile@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening adherence (time frame: up to 6 months from end of program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.