NCT04450264

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable breast-cancer

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

February 5, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

June 25, 2020

Results QC Date

November 20, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Breast CancerScreeningAfrican ImmigrantWomenNew York CityFrench

Outcome Measures

Primary Outcomes (2)

  • Mammogram Intention

    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

    Immediate after the program (program average 75 minutes)

  • Mammogram Location and Appointment

    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

    Immediate after the program (program average 75 minutes)

Secondary Outcomes (3)

  • Perceived Risk

    Immediate after the program (program average 75 minutes)

  • Comparison Perceived Risk

    Immediate after the program (program average 75 minutes)

  • Self-Efficacy for Mammography

    Immediate after the program (program average 75 minutes)

Study Arms (1)

Breast Cancer Education Program

OTHER
Behavioral: African Immigrant Breast Cancer Education Program

Interventions

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.

Breast Cancer Education Program

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Stakeholder/gatekeeper in the African immigrant community, and read and speak English or French.
  • Women 40 years of age or older;
  • Born in Africa;
  • Speak English or French.

You may not qualify if:

  • \<18 years of age
  • Cannot read and speak English or French
  • AIM 2:
  • ≥ 38 years of age
  • Women born in Africa, and read and speak English or French.
  • \<38 years of age
  • Cannot read and speak English or French

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

Related Publications (15)

  • Erwin DO, Johnson VA, Trevino M, Duke K, Feliciano L, Jandorf L. A comparison of African American and Latina social networks as indicators for culturally tailoring a breast and cervical cancer education intervention. Cancer. 2007 Jan 15;109(2 Suppl):368-77. doi: 10.1002/cncr.22356.

    PMID: 17173279BACKGROUND
  • Saad-Harfouche FG, Jandorf L, Gage E, Thelemaque LD, Colon J, Castillo AG, Trevino M, Erwin DO. Esperanza y Vida: training lay health advisors and cancer survivors to promote breast and cervical cancer screening in Latinas. J Community Health. 2011 Apr;36(2):219-27. doi: 10.1007/s10900-010-9300-3.

    PMID: 20711645BACKGROUND
  • Hurtado-de-Mendoza A, Song M, Kigen O, Jennings Y, Nwabukwu I, Sheppard VB. Addressing cancer control needs of African-born immigrants in the US: a systematic literature review. Prev Med. 2014 Oct;67:89-99. doi: 10.1016/j.ypmed.2014.07.006. Epub 2014 Jul 14.

    PMID: 25034729BACKGROUND
  • Wafula EG, Snipes SA. Barriers to health care access faced by black immigrants in the US: theoretical considerations and recommendations. J Immigr Minor Health. 2014 Aug;16(4):689-98. doi: 10.1007/s10903-013-9898-1.

    PMID: 24006174BACKGROUND
  • Janz NK, Becker MH. The Health Belief Model: a decade later. Health Educ Q. 1984 Spring;11(1):1-47. doi: 10.1177/109019818401100101.

    PMID: 6392204BACKGROUND
  • Kreuter MW, Green MC, Cappella JN, Slater MD, Wise ME, Storey D, Clark EM, O'Keefe DJ, Erwin DO, Holmes K, Hinyard LJ, Houston T, Woolley S. Narrative communication in cancer prevention and control: a framework to guide research and application. Ann Behav Med. 2007 Jun;33(3):221-35. doi: 10.1007/BF02879904.

    PMID: 17600449BACKGROUND
  • Kreuter MW, Holmes K, Alcaraz K, Kalesan B, Rath S, Richert M, McQueen A, Caito N, Robinson L, Clark EM. Comparing narrative and informational videos to increase mammography in low-income African American women. Patient Educ Couns. 2010 Dec;81 Suppl(Suppl):S6-14. doi: 10.1016/j.pec.2010.09.008. Epub 2010 Nov 10.

    PMID: 21071167BACKGROUND
  • Dillard AJ, Fagerlin A, Dal Cin S, Zikmund-Fisher BJ, Ubel PA. Narratives that address affective forecasting errors reduce perceived barriers to colorectal cancer screening. Soc Sci Med. 2010 Jul;71(1):45-52. doi: 10.1016/j.socscimed.2010.02.038. Epub 2010 Mar 21.

    PMID: 20417005BACKGROUND
  • Larkey LK, Lopez AM, Minnal A, Gonzalez J. Storytelling for promoting colorectal cancer screening among underserved Latina women: a randomized pilot study. Cancer Control. 2009 Jan;16(1):79-87. doi: 10.1177/107327480901600112.

    PMID: 19078934BACKGROUND
  • Jandorf L, Braschi C, Ernstoff E, Wong CR, Thelemaque L, Winkel G, Thompson HS, Redd WH, Itzkowitz SH. Culturally targeted patient navigation for increasing african americans' adherence to screening colonoscopy: a randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2013 Sep;22(9):1577-87. doi: 10.1158/1055-9965.EPI-12-1275. Epub 2013 Jun 10.

    PMID: 23753039BACKGROUND
  • Sriphanlop P, Jandorf L, Kairouz C, Thelemaque L, Shankar H, Perumalswami P. Factors related to hepatitis B screening among Africans in New York City. Am J Health Behav. 2014 Sep;38(5):745-54. doi: 10.5993/AJHB.38.5.12.

    PMID: 24933144BACKGROUND
  • Kreuter MW, Lukwago SN, Bucholtz RD, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav. 2003 Apr;30(2):133-46. doi: 10.1177/1090198102251021.

    PMID: 12693519BACKGROUND
  • Bollinger S, Kreuter MW. Real-time moment-to-moment emotional responses to narrative and informational breast cancer videos in African American women. Health Educ Res. 2012 Jun;27(3):537-43. doi: 10.1093/her/cys047. Epub 2012 Apr 11.

    PMID: 22498923BACKGROUND
  • Erwin DO, Trevino M, Saad-Harfouche FG, Rodriguez EM, Gage E, Jandorf L. Contextualizing diversity and culture within cancer control interventions for Latinas: changing interventions, not cultures. Soc Sci Med. 2010 Aug;71(4):693-701. doi: 10.1016/j.socscimed.2010.05.005. Epub 2010 May 25.

    PMID: 20646810BACKGROUND
  • Crookes DM, Njoku O, Rodriguez MC, Mendez EI, Jandorf L. Promoting colorectal cancer screening through group education in community-based settings. J Cancer Educ. 2014 Jun;29(2):296-303. doi: 10.1007/s13187-013-0599-1.

    PMID: 24385340BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Jamilia Sly
Organization
Icahn School of Medicine at Mount Sinai

Study Officials

  • Jamilia R Sly, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

February 5, 2020

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

December 13, 2024

Results First Posted

December 13, 2024

Record last verified: 2024-11

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, SAP, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Anyone who wishes to access the data.

Locations