Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04450264
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2020-06-25
Brief Title:
Increasing African Immigrant Womens Participation in Breast Cancer Screening
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Increasing African Immigrants Breast Cancer Screening
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIBCS
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 primarypreventive 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 2000 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 teams 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
Detailed Description:
The goal of Aim 1 is to collect formative data via a mixed methods approach and use those results to culturally adapt the Witness Project for African immigrant populations Cultural adaptation will follow the stage model outlined by Barrera et al48 The model includes five stages 1 information gathering to determine which intervention components to modify 2 preliminary adaptation design that integrates information from stage 1 to inform preliminary modification of the original intervention 3 preliminary adaptation tests to pilot the intervention for feasibility and acceptability 4 adaptation refinement with decisions informed a leadership teamadvisory board and 5 cultural adaptation trial to test the effectiveness of the intervention in changing health outcomes As this is the first step in this line of research the proposed study will only follow stages 1-4 The Witness Project has three main components that will be culturally adapted 1 educational presentation addressing myths barriers and values related to breast cancer and mammography 2 culturally matched peer led narrative about breast cancer experience 3 experiential education about breast anatomy and self-examination The quantitative surveys will be conducted first The results will inform the refinement of the focus group guide and in-depth interview questions Participant Recruitment for Focus Groups Interviews and Surveys There is a tremendous diversity of African nations and languages focusing research on individual African nations andor native languages is not feasible within the proposed study Given that French and English are the most prevalent non-native languages spoken by African immigrants in New York City the study team has chosen to focus on targeting individuals who speak these languages as a first step in this line of research All participants will be recruited from African immigrant communities in NYC Based on the prior experience of the study teams community partners the majority of the populations that they serve are from Senegal Mali Ivory Coast and Burkina Faso In anticipation of wide variations in cultural values barriers and benefits the study team will thus use a maximum variation sampling approach to allow discovery of central themes core elements andor shared dimensions that cut across a diverse sample of participants The study team has a well-established collaborative relationship with gatekeepers in the African immigrant community and have successfully recruited African-born persons into prior studies49 and therefore anticipate successful recruitment for this proposed research Participants will be recruited for in-depth interviews focus groups and surveys through IRB approved flyers at community sites
Quantitative Surveys The study team will conduct surveys N50 to assess predictors of breast cancer screening among African immigrant women The survey will be conducted by a bilingual RA and take about 15-30 minutes to Focus Groups The study team will ask the community partners to assist the team with identifying potential participants for the focus groups The goal of the focus groups is to gather rich qualitative data from African immigrant stakeholders and gatekeepers about the breast cancer screening needs of women within their communities The study team will deliver informational presentations about the focus groups and the proposed study at events and meetings held by the community partners The study team will conduct one focus group with gatekeepers and stakeholders in English and the other two focus groups will be conducted with African immigrant women in French and English The focus groups will take 75-90 minutes to complete and will be conducted by a bilingual RA In-depth Interviews An RA will approach potential participants and explain the purpose of the study verify eligibility and obtain informed consent Participants will be asked to discuss their beliefs about barriers and facilitators patients may face as they consider breast cancer screening The duration of the in-depth interview and focus group will be approximately one hour including the interview and completion of a demographic questionnaire
Recruitment and Iterative Program Development After the completion of the interviews and focus groups in Aim 1 a 33 table of themes categorized using the PEN-3 model 25 will be produced for each of the three components of the Witness Project 1 addressing myths barriers and values 2 culturally relevant breast cancer narrative 3 experiential breast education Themes will be categorized in the following domains cultural empowerment and relationships and expectations These themes will inform how the intervention components for the educational narrative program should be adapted for an African immigrant audience Cultural barriers identified will also be addressed in the culturally relevant narrative by providing examples and suggestions for coping with these perceived risks The study team will invite participants N20 to give feedback on the first iteration of the educational program components procedures and feasibility and acceptability of the interventions
Populations Sites and Recruitment for Programs Over the past 20 years US African immigration has increased 750 with a high concentration settling in NYC6061 Experienced outreach coordinators assisted by the consultants will recruit local community faith-based and other social organizations to host breast cancer educational programs as the study team has successfully done for previous studies 2420 Research staff will focus on sites that include African-born immigrant women 40 years of age and older A program will be scheduled by the coordinator and individuals at the community sites will be approached to participate in a breast cancer educational program The study team will emphasize the goal of the programs such that the study team will over recruit those eligible for breast cancer screening The study team will conduct a total of eight programs in English N4 and French N4 Based on prior experience the study team anticipates that about 15 participants will attend each program and of those attendees 50 will be eligible for breast cancer screening N8 Thus the study team will recruit a total of 64 eligible women at each program When recruiting program sites the RA will emphasize the language in which the program will be conducted
Conducting Educational Intervention Programs Trained staff will conduct the educational programs Trained staff will enroll and collect data from English- and French- speaking African-born immigrants working with the consultants Information and resources about breast cancer and primary care clinical services will be available to all participants including the mobile mammography van operated by the institution The study team will inform both insured and uninsured participants about the Cancer Services Program and local clinical service resources for those without primary care physicians as well as questions to guide them about asking clinicians about breast cancer screenings when they have medical appointments The program will take approximately 60 minutes to complete The program will also use a culturally matched peer approach to educate and model successful experiences with mammography screening
Quantitative Surveys The study team will conduct surveys N50 to assess predictors of breast cancer screening among African immigrant women The survey will be conducted by a bilingual RA and take about 15-30 minutes to Focus Groups The study team will ask the community partners to assist the team with identifying potential participants for the focus groups The goal of the focus groups is to gather rich qualitative data from African immigrant stakeholders and gatekeepers about the breast cancer screening needs of women within their communities The study team will deliver informational presentations about the focus groups and the proposed study at events and meetings held by the community partners The study team will conduct one focus group with gatekeepers and stakeholders in English and the other two focus groups will be conducted with African immigrant women in French and English The focus groups will take 75-90 minutes to complete and will be conducted by a bilingual RA In-depth Interviews An RA will approach potential participants and explain the purpose of the study verify eligibility and obtain informed consent Participants will be asked to discuss their beliefs about barriers and facilitators patients may face as they consider breast cancer screening The duration of the in-depth interview and focus group will be approximately one hour including the interview and completion of a demographic questionnaire
Recruitment and Iterative Program Development After the completion of the interviews and focus groups in Aim 1 a 33 table of themes categorized using the PEN-3 model 25 will be produced for each of the three components of the Witness Project 1 addressing myths barriers and values 2 culturally relevant breast cancer narrative 3 experiential breast education Themes will be categorized in the following domains cultural empowerment and relationships and expectations These themes will inform how the intervention components for the educational narrative program should be adapted for an African immigrant audience Cultural barriers identified will also be addressed in the culturally relevant narrative by providing examples and suggestions for coping with these perceived risks The study team will invite participants N20 to give feedback on the first iteration of the educational program components procedures and feasibility and acceptability of the interventions
Populations Sites and Recruitment for Programs Over the past 20 years US African immigration has increased 750 with a high concentration settling in NYC6061 Experienced outreach coordinators assisted by the consultants will recruit local community faith-based and other social organizations to host breast cancer educational programs as the study team has successfully done for previous studies 2420 Research staff will focus on sites that include African-born immigrant women 40 years of age and older A program will be scheduled by the coordinator and individuals at the community sites will be approached to participate in a breast cancer educational program The study team will emphasize the goal of the programs such that the study team will over recruit those eligible for breast cancer screening The study team will conduct a total of eight programs in English N4 and French N4 Based on prior experience the study team anticipates that about 15 participants will attend each program and of those attendees 50 will be eligible for breast cancer screening N8 Thus the study team will recruit a total of 64 eligible women at each program When recruiting program sites the RA will emphasize the language in which the program will be conducted
Conducting Educational Intervention Programs Trained staff will conduct the educational programs Trained staff will enroll and collect data from English- and French- speaking African-born immigrants working with the consultants Information and resources about breast cancer and primary care clinical services will be available to all participants including the mobile mammography van operated by the institution The study team will inform both insured and uninsured participants about the Cancer Services Program and local clinical service resources for those without primary care physicians as well as questions to guide them about asking clinicians about breast cancer screenings when they have medical appointments The program will take approximately 60 minutes to complete The program will also use a culturally matched peer approach to educate and model successful experiences with mammography screening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21MD012863-01A1 | NIH | None | httpsreporternihgovquickSearchR21MD012863-01A1 |