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Increasing African Immigrant Women's Participation in Breast Cancer Screening (AIBCS)

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ClinicalTrials.gov Identifier: NCT04450264
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jamilia Sly, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: African Immigrant Breast Cancer Education Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This trial will have a single arm design. All participants will receive the same intervention as the purpose of the current study is to assess feasibility and acceptability of the intervention. The intervention will however, be delivered in English or French (according to language preference of the participant).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Increasing African Immigrant's Breast Cancer Screening
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Breast Cancer Education Program Behavioral: African Immigrant Breast Cancer Education Program
African immigrant women are at significant risk for not participating in preventive screening, such as for breast cancer. Thus, this project will culturally adapt an existing evidenced-based, the Witness Project, by identifying potential barriers and guided by the Health Belief Model incorporate those findings into a group-based narrative education program for English and French-speaking African immigrant women. The program content will include: (1) information about the benefits of early detection of breast cancer screening, (2) education about disparities in breast cancer, (3) disparities in breast cancer screening among African immigrant women, and (4) will address the unique barriers and facilitators of African immigrant women identified in Aim 1 of this study. The program will use a culturally matched peer approach to educate and model successful experiences with mammography screening.




Primary Outcome Measures :
  1. Mammogram intention [ Time Frame: Immediate ]
    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? a. Very unlikely b. Unlikely c. Likely d. Very Likely

  2. Mammogram location and appointment [ Time Frame: Immediate ]
    Participants' intentions to complete breast cancer screening: Have you thought about where you will have your next mammogram? a. Yes b. No Have you thought about making the appointment? a. Yes b. No


Secondary Outcome Measures :
  1. Perceived Risk [ Time Frame: Immediate ]
    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

  2. Comparison Perceived Risk [ Time Frame: Immediate ]
    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

  3. Self-Efficacy for Mammography [ Time Frame: Immediate ]
    Ten items will be used to examine participants' self-efficacy for undergoing mammography using a 5-point Likert-type scale. Full scale from 1 to 5, with higher score indicating greater self-efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

AIM 1:

Inclusion Criteria

  • ≥ 18 years of age
  • Stakeholder/gatekeeper in the African immigrant community, and read and speak English or French.

Exclusion Criteria

  • <18 years of age
  • Cannot read and speak English or French

AIM 2:

Inclusion Criteria

  • ≥ 40 years of age
  • Women born in Africa, and read and speak English or French.

Exclusion Criteria

  • <40 years of age
  • Cannot read and speak English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450264


Contacts
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Contact: Jamilia R Sly, PhD 212-824-7813 jamilia.sly@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Jamilia R Sly, PhD    212-824-7813    jamila.sly@mssm.edu   
Contact: Lina Jandorf, MA       lina.jandorf@mssm.edu   
Principal Investigator: Jamilia R Sly, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Jamilia R Sly, PhD Icahn School of Medicine at Mount Sinai
Publications:

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Responsible Party: Jamilia Sly, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04450264    
Other Study ID Numbers: GCO 17-2188
R21MD012863-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamilia Sly, Icahn School of Medicine at Mount Sinai:
Breast Cancer
Screening
African Immigrant
Women
New York City
French
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases