NCT05089292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

October 15, 2021

Results QC Date

May 8, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Breast cancer screeningHealth educationChinese immigrantHealth disparities

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Change in Breast Cancer Knowledge

    baseline and 6 months post intervention

Study Arms (1)

Chinese Immigrants

EXPERIMENTAL

NYC Chinese immigrants provided with narrative breast health education

Behavioral: Narrative breast health education

Interventions

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

Chinese Immigrants

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Lina Jandorf
Organization
Icahn School of Medicine at Mount Sinai

Study Officials

  • Lina Jandorf

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Pre/Post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 22, 2021

Study Start

July 1, 2021

Primary Completion

December 13, 2022

Study Completion

December 13, 2022

Last Updated

June 10, 2024

Results First Posted

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
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.

Locations