An interventional study of Individual Education and Community Navigation in Breast Cancer Prevention, sponsored by University of Puerto Rico Comprehensive Cancer Center. Recruiting at 1 site in Puerto Rico. Open to female participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University of Puerto Rico Comprehensive Cancer Center · Not applicable, Interventional, and Screening
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 Mamografía 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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,020 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Puerto Rico Comprehensive Cancer Center is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Individual educational component
Behavioral: Individual Education
Behavioral: Individual Education · Other: Community Navigation
Behavioral: Individual Education · Other: Community Navigation · Other: Healthcare Providers Educational Intervention
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.
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.
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.
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6-months
Plan to share: Undecided — 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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University of Puerto Rico Comprehensive Cancer Center