Active Mammography and Counseling (MAMO)

University of Puerto Rico Comprehensive Cancer Center

Status: Not yet enrolling

Conditions: Breast Cancer Prevention

Treatments: Behavioral: Individual Education; Other: Healthcare Providers Educational Intervention; Other: Community Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07238088

SUB-OTA No. 6922-03-COVID-S026 (Other Grant/Funding Number)

2409000060

Details and patient eligibility

About

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.

Enrollment: 1,020 estimated patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women (biological sex at birth) aged 40- 74
• Residing in one of 39 municipalities across Puerto Rico whose having a low breast cancer screening rate below the median (38.6%): Aibonito, Arecibo, Barceloneta, Caguas, Camuy, Comerío, Corozal, Florida, Las Piedras, Loíza, Naguabo, Vieques, Villalba, Añasco, Carolina, Cayey, Dorado, Guayanilla, Guaynabo, Isabela, Juana Diaz, Juncos, Luquillo, Manatí, Peñuelas, Quebradillas, Cabo Rojo, Canóvanas, Ceiba, Ciales, Coamo, Culebra, Fajardo, Morovis, Ponce, Sabana Grande, San Juan, Santa Isabel, and Trujillo Alto.
• Overdue for breast cancer screening by two or more years, in accordance with USPSTF guidelines
• Adequate cognitive orientation as verified by a brief version of the Mini-Mental State Examination
• Access to a telephone for follow-up and communication
• Ability to read and comprehend Spanish to engage with educational materials.

Exclusion criteria

• Women outside the specified age range (40-74)
• Up to date in breast cancer screening according to the USPSTF recommendations.
• No cognitive orientation
• Participants without access to a telephone
• Unable to read and comprehend Spanish
• Women undergoing active cancer treatment
• History of radical mastectomy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,020 participants in 3 patient groups

Educational Level

Experimental group

Description:

Individual educational component

Treatment:

Behavioral: Individual Education

Navigation Level

Experimental group

Treatment:

Other: Community Navigation

Behavioral: Individual Education

Integration level

Experimental group

Treatment:

Other: Community Navigation

Other: Healthcare Providers Educational Intervention

Behavioral: Individual Education