- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05089292
Increasing Breast Cancer Screening in Chinese Immigrants
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 40 years of age
- female
- born in China
- read and speak Cantonese, Mandarin, or English
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chinese Immigrants
NYC Chinese immigrants provided with 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire
Time Frame: immediately post presentation (presentation approximately 1 hour)
|
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
Time Frame: Baseline
|
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
Time Frame: 7 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Breast Cancer Knowledge
Time Frame: baseline and 6 months post intervention
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lina Jandorf, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-20-01174
- R21CA249261 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Screening Mammogram
-
Beekley MedicalElizabeth Wende Breast Care, LLCCompleted
-
University of North Carolina, Chapel HillWithdrawnMammogram ScheduledUnited States
-
National University Health System, SingaporeCompletedMammogram ScheduledSingapore
-
Brigham and Women's HospitalNational Cancer Institute (NCI); Mayo Clinic; Albert Einstein College of Medicine and other collaboratorsCompletedMammographic Density | Abnormal MammogramUnited States
-
Micrima, Ltd.Completed
-
University of PennsylvaniaCompletedPeople Due for Mammogram | People Due for Colonoscopy | People Due for Blood Pressure Test | People Due for Cholesterol TestUnited States
-
Pamukkale UniversityThe Scientific and Technological Research Council of TurkeyActive, not recruitingCancer Screening | Men's Health ScreeningTurkey (Türkiye)
-
Menssana Research, Inc.University of Erlangen-Nürnberg; Zuyderland Medical Centre; Mount Vernon Cancer...Not yet recruitingBreast Cancer | Abnormal Mammogram, UnspecifiedNetherlands, Germany, United Kingdom
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); Massachusetts League of Community Health Centers and other collaboratorsNot yet recruitingTobacco Cessation | Cervical Cancer Screening | Breast Cancer Screening | Colon Cancer Screening
-
Max Planck Institute for Human DevelopmentDartmouth-Hitchcock Medical CenterCompleted
Clinical Trials on Narrative breast health education
-
Wake Forest University Health SciencesAtrium Health Levine Cancer InstituteCompleted
-
Mustafa Kemal UniversityNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes Self-management | Diabetes EducationTurkey (Türkiye)
-
Hacettepe UniversityCompletedBreast Cancer | Health Knowledge, Attitudes, PracticeTurkey (Türkiye)
-
University of Arkansas, FayettevilleNational Cancer Institute (NCI); University of California, Los Angeles; Thomas... and other collaboratorsActive, not recruitingVaccine-Preventable Diseases | Human Papilloma VirusUnited States
-
University of HoustonUnknownAlcohol; Use, Problem | Marijuana Usage
-
Kırklareli UniversityOrdu University Scientific Research Projects Coordination DepartmentCompletedHealth Education | Women's HealthTurkey
-
Istanbul Aydın UniversityActive, not recruiting
-
Sakarya UniversityCompleted