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| ID | Type | Description | Link |
|---|---|---|---|
| SUB-OTA No. 6922-03-COVID-S026 | Other Grant/Funding Number | WESTAT, INC. |
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The Puerto Rico Community Engagement Alliance (PR-CEAL) is an NIH-funded initiative which aims to improve health literacy and healthcare access across Puerto Rico. In 2024, the program developed a new study which goal is to improve breast cancer screening rates in Puerto Rico titled Monitoreo Activo de MamografÃa y Orientación (MAMO). This multi-level study will recruit non-adherent women based on residence, age (40 to 74 years old), and having had two or more years since their last breast cancer screening. The intervention will focus on 39 municipalities with screening rates below the median, through three different levels: educational, navigation, and integration.
At the educational level, the intervention will employ a community-based recruitment strategy led by Community Health Workers (CHWs), who will identify eligible women at community venues and conduct follow-up via telephone to provide educational support. Drawing on findings from a previous pilot study and addressing barriers specific to non- adherent women, the navigation-level intervention will incorporate the role of a Community Navigator to deliver tailored support and facilitate breast cancer screening uptake through collaboration with local networks and partnerships. The integration-level intervention will build upon the educational and navigation components by enhancing knowledge, attitudes, skills, and organizational processes within Federally Qualified Health Clinics (FQHCs). This component is designed to foster a supportive healthcare environment that encourages routine mammography screening. The integration-level intervention will be implemented in four FQHCs across PR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Level | Experimental | Individual educational component |
|
| Navigation Level | Experimental |
| |
| Integration level | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Education | Behavioral | This component was developed using Intervention Mapping (IM) as a methodological framework and adapted from two evidence-based programs: "Unidas por la Vida" and "Nuestra Cocina: Mesa Buena, Vida Sana". The intervention includes one-on-one educational sessions led by Community Health Workers (CHWs), who will use tailored educational materials to guide participants and provide them with a take-home kit to promote and assist with mammography scheduling. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who self-reported having had a mammogram | Participants will receive follow-up calls and emails every 3 months for 6-months to document their efforts to attend the clinic, undergo a mammogram, and receive a progress report from the clinicians about their mammogram result. The categories to collect this information are: Yes/No/Refuse to Answer. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels | The mammogram rate measure will be calculated based on the number of participants who reported undergoing a mammogram and receiving the results (numerator) with respect to the number of participants in the same intervention level (denominator). This measure will be collected at the intervention level. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the patient-provider communication satisfaction considering intervention level: the Educational, Navigation, and Integration Levels | Patient-provider communication satisfaction will be evaluated using a Likert Scale ranging from 0 (Strongly Agree) to 4 (Strongly Disagree). Through a phone call follow-up, the participant will provide their response. This measure will be collected at the intervention level. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana T Medina Laabes, MS, CRC | Contact | 787-772-8300 | 5911 | dmedina@cccupr.org |
| Karelys Canales, MPHE, CHES | Contact | 787-772-8300 | 1154 | kcanales@cccupr.org |
| Name | Affiliation | Role |
|---|---|---|
| Vivian Colon Lopez, PhD, MPH | UPR-Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPR-Comprehensive Cancer Center | Recruiting | San Juan | 00959 | Puerto Rico |
According to our Data Management and Sharing Plan, raw data will only be available for study personnel and research activities included in the approved Institutional Review Board (IRB) protocol. To protect human research participants' privacy, rights, and confidentiality, we will manage all scientific data derived from human subjects in strict adherence to ethical guidelines and privacy protection measures, including de-identification techniques and obtaining Certificates of Confidentiality. The IRB will oversee all processes to guarantee compliance with these standards. Based on the statements, we will consider what data would be shared and for what purpose.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This study begins with a total of 1,020 participants, distributed equally across three intervention groups after filtering by municipality and applying inclusion criteria. Each group represents a progressively more intensive intervention level, designed to assess the impact of multi-component strategies on breast cancer screening rates among women aged 40-74 who are overdue for mammography by at least 12 months.
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| Community Navigation | Other | At this level, a community navigator service will be implemented to help participants overcome barriers to mammography screening. Seven community navigators will provide personalized support to address common challenges, including scheduling appointments, transportation, and access to healthcare services. These interventions leverage culturally tailored training to enable navigators to address barriers to breast cancer screening and enhance health literacy within their communities. The study intervention will include a specially designed training program for Community Navigators, emphasizing a culturally tailored curriculum to equip participants with the knowledge and skills necessary to educate and support their communities effectively. |
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| Healthcare Providers Educational Intervention | Other | The provider-level interventions will engage both clinical and administrative personnel who are actively employed at Federally Qualified Health Clinics (FQHCs). Two educational modules are being developed for the integration-level intervention. The educational content is designed to address provider-level barriers to breast cancer screening-an area that remains underexplored in the literature compared to patient-level factors. By engaging healthcare providers in FQHCs, this level aims to ensure women receive strong, consistent recommendations for mammography from trusted healthcare professionals. |
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| Up to 6 months |
| Up to 6-months |
| D017437 |
| Skin and Connective Tissue Diseases |