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Increasing Breast Cancer Screening in Chinese Immigrants

Primary Purpose

Screening Mammogram

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative breast health education
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Screening Mammogram focused on measuring Breast cancer screening, Health education, Chinese immigrant, Health disparities

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥ 40 years of age
  • female
  • born in China
  • read and speak Cantonese, Mandarin, or English

Exclusion Criteria:

- none

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chinese Immigrants

Arm Description

NYC Chinese immigrants provided with narrative breast health education

Outcomes

Primary Outcome Measures

Screening mammogram completion
Self-report completion of screening mammogram (Yes/No)

Secondary Outcome Measures

Screening mammogram intention
Question: How likely are you to undergo a screening mammogram in the next 6 months? (Very likely, Somewhat likely, Not sure, Somewhat not likely, Not at all likely)
Change in Feasibility and Acceptability Questionnaire
Pre- and post-program survey to access feasibility and acceptability of adapted narrative education program. Full scale from 5 - 25, with a higher score indicating greater acceptability.

Full Information

First Posted
October 15, 2021
Last Updated
December 15, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05089292
Brief Title
Increasing Breast Cancer Screening in Chinese Immigrants
Official Title
Increasing Breast Cancer Screening in Chinese Immigrants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening Mammogram
Keywords
Breast cancer screening, Health education, Chinese immigrant, Health disparities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre/Post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chinese Immigrants
Arm Type
Experimental
Arm Description
NYC Chinese immigrants provided with narrative breast health education
Intervention Type
Behavioral
Intervention Name(s)
Narrative breast health education
Intervention Description
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
Primary Outcome Measure Information:
Title
Screening mammogram completion
Description
Self-report completion of screening mammogram (Yes/No)
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
Screening mammogram intention
Description
Question: How likely are you to undergo a screening mammogram in the next 6 months? (Very likely, Somewhat likely, Not sure, Somewhat not likely, Not at all likely)
Time Frame
6 months post intervention
Title
Change in Feasibility and Acceptability Questionnaire
Description
Pre- and post-program survey to access feasibility and acceptability of adapted narrative education program. Full scale from 5 - 25, with a higher score indicating greater acceptability.
Time Frame
Baseline and 6 months post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥ 40 years of age female born in China read and speak Cantonese, Mandarin, or English Exclusion Criteria: - none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lina Jandorf
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
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.

Learn more about this trial

Increasing Breast Cancer Screening in Chinese Immigrants

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