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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA249261 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.
A total of 156 participants will be recruited during the entire study.
In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.
In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Immigrants | Experimental | NYC Chinese immigrants provided with narrative breast health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrative breast health education | Behavioral | Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire | Post-program survey to access acceptability of adapted narrative education program. Full-scale from 0% to 100%, with a higher percent indicating greater acceptability. An arbitrary cutoff value of 80% acceptance will determine the interventions' acceptability for the study. | immediately post presentation (presentation approximately 1 hour) |
| Number of Participants Who Were Engaged in Program | Percent of participants who showed up to the Chinese-community-based organizations and would like to participate in the program to assess engagement rate of participants | Baseline |
| Percentage of Community Organizations Willing to Host Program | Percentage of Chinese Community-based organizations who were willing to host the program to assess feasibility. Engagement rate of Chinese-community-based organizations was used to access feasibility | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Breast Cancer Knowledge | Pre- and post-program survey to access change in breast cancer knowledge. Each correct answer counted as 1 point, each incorrect one as 0, and skipped questions as 0. Full scale from 0-6, with a higher score indicates more knowledge. | baseline and 6 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
- none
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| Name | Affiliation | Role |
|---|---|---|
| Lina Jandorf | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
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Results for Aim 2 of study provided. Gatekeepers and stakeholders were not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chinese Immigrants | NYC Chinese immigrants provided with narrative breast health education Narrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chinese Immigrants | NYC Chinese immigrants provided with narrative breast health education Narrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire | Post-program survey to access acceptability of adapted narrative education program. Full-scale from 0% to 100%, with a higher percent indicating greater acceptability. An arbitrary cutoff value of 80% acceptance will determine the interventions' acceptability for the study. | Posted | Count of Participants | Participants | immediately post presentation (presentation approximately 1 hour) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chinese Immigrants | NYC Chinese immigrants provided with narrative breast health education Narrative breast health education: Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community |
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The study utilized a convenience sample recruited from Chinese community-based organizations located in New York City, which may have contributed to the high percentage of insurance involvement (100%), primary care physician access (100%), and participants living in the United States for more than 20 years. Thus, the generalizability of the findings may be limited, particularly for populations with inadequate insurance coverage.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lina Jandorf | Icahn School of Medicine at Mount Sinai | (212) 659-5506 | lina.jandorf@mssm.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2020 | May 7, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2022 | May 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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Pre/Post-test design
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Last Mammogram | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Who Were Engaged in Program | Percent of participants who showed up to the Chinese-community-based organizations and would like to participate in the program to assess engagement rate of participants | 107 is the number of people in the participating Chinese-community-based organizations. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Change in Breast Cancer Knowledge | Pre- and post-program survey to access change in breast cancer knowledge. Each correct answer counted as 1 point, each incorrect one as 0, and skipped questions as 0. Full scale from 0-6, with a higher score indicates more knowledge. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months post intervention |
|
|
|
| Primary | Percentage of Community Organizations Willing to Host Program | Percentage of Chinese Community-based organizations who were willing to host the program to assess feasibility. Engagement rate of Chinese-community-based organizations was used to access feasibility | Posted | Number | percentage of organizations | 7 months | organizations | organizations |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |