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NCT04450264: AIBCS

Increasing African Immigrant Women's Participation in Breast Cancer Screening

Completed NA Results posted Last updated 13 December 2024
What this trial tests

NA trial testing African Immigrant Breast Cancer Education Program in Breast Cancer in 155 participants. Completed in 29 June 2023.

Timeline
5 February 2020
Primary endpoint
29 June 2023
29 June 2023

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment155
Start date5 February 2020
Primary completion29 June 2023
Estimated completion29 June 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 74, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mammogram Intention Primary · Immediate after the program (program average 75 minutes)

Participants' intentions to complete breast cancer screening by responding to How likely or unlikely is it that you will have a mammogram in the next 12 months? 1. Very unlikely 2. Unlikely 3. Likely d 4. Very Likely

GroupValue95% CI
Breast Cancer Education Program1.90± 0.30
Mammogram Location and Appointment Primary · Immediate after the program (program average 75 minutes)

Participants' intentions to complete breast cancer screening: Have you thought about making an appointment and where you will have your next mammogram? a. Yes b. No

Yes
GroupValue95% CI
Breast Cancer Education Program55
No/Not sure
GroupValue95% CI
Breast Cancer Education Program6
Perceived Risk Secondary · Immediate after the program (program average 75 minutes)

Participants' perceived risk of developing breast cancer: What do you think are the chances that you will have breast cancer at some point in your life? 1. Very low 2. Somewhat low 3. Moderate 4. Somewhat high 5. Very high

Very Low
GroupValue95% CI
Breast Cancer Education Program32
Somewhat Low
GroupValue95% CI
Breast Cancer Education Program9
Moderate
GroupValue95% CI
Breast Cancer Education Program15
Somewhat High
GroupValue95% CI
Breast Cancer Education Program4
Very High
GroupValue95% CI
Breast Cancer Education Program2
Comparison Perceived Risk Secondary · Immediate after the program (program average 75 minutes)

Participants' perceived risk of developing breast cancer: Compared to the average person your age and gender, would you say that you are... 1. Less likely to get breast cancer 2. About as likely to get breast cancer 3. More likely to get breast cancer

Less Likely
GroupValue95% CI
Breast Cancer Education Program38
As Likely
GroupValue95% CI
Breast Cancer Education Program17
More Likely
GroupValue95% CI
Breast Cancer Education Program6
Self-Efficacy for Mammography Secondary · Immediate after the program (program average 75 minutes)

Ten items will be used to examine participants' self-efficacy for undergoing mammography using a 5-point Likert-type scale. Full scale from 10 to 50, with higher score indicating greater self-efficacy

GroupValue95% CI
Breast Cancer Education Program40.83± 8.24

Sponsor's own description

New York City (NYC) is home to a large and diverse immigrant population. Many of these groups face significant barriers to preventive health care, including lack of insurance, poor health care access and language difficulties. Most African immigrant women are likely to live below the poverty line and have low health literacy, are less likely to have health insurance and visit a doctor, particularly for primary/preventive care. Without access to primary care, many preventive services, such as breast cancer screenings go unattended. The barriers and facilitators to breast cancer screening for other minority groups from underserved populations, such as African Americans and Latina women have been studied. Less is known about these for African immigrant women and how to most effectively engage their participation in regular screening. Data of over 2,000 African-born immigrants living in NYC show that 77% report not having health insurance; 75% do not have a primary care physician; and 57% have less than a high school education. As for cancer screening, when corrected for age, 44% have never had a mammogram. Through the study team's unique collaboration with the African Services Committee and the African Advisory Council of the Bronx, two non-governmental community-based service organizations, the study team is poised to have a significant impact on these immigrant women, who have emigrated from more than 20 countries in Africa. This is a population with great need for increased breast cancer knowledge, access to breast cancer screening, and basic medical care. The Health Belief Model (HBM) provides a framework for addressing cultural health barriers by positing that making a decision to engage in a health behavior is determined by weighing perceived threats versus benefits. The long term goal of the proposed project is to conduct a randomized clinical trial that tests the adapted intervention to increase breast cancer screening rates for African-born immigrants. In the short term, the study team plans to pursue the following specific aims: (1) Identify barriers and facilitators to breast cancer screening among African-born immigrants and (2) Culturally adapt and pilot test the Witness Project breast cancer education program for African-born women. Thus, the study team will culturally adapt an effective, innovative intervention to address this significant health disparity in African-born immigrant communities.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04450264.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing