Active Mammography and Counseling (MAMO)

Monitoreo Activo de Mamografía y Orientación

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Prevention
• Intervention / Treatment: Behavioral: Individual Education; Other: Community Navigation; Other: Healthcare Providers Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 1020
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana T Medina Laabes, MS, CRC; Phone Number: 5911 787-772-8300; Email: dmedina@cccupr.org
• Study Contact Backup: Name: Karelys Canales, MPHE, CHES; Phone Number: 1154 787-772-8300; Email: kcanales@cccupr.org

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00959
    • Recruiting
    • UPR-Comprehensive Cancer Center
    • Contact: Diana T Medina Laabes, MS; Phone Number: 5911 7877728300; Email: dmedina@cccupr.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 one or more years, in accordance with annual 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 annual 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Level; Individual educational component	Behavioral: Individual Education; 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.
Experimental: Navigation Level	Behavioral: Individual Education; 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.; Other: Community Navigation; 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.
Experimental: Integration level	Behavioral: Individual Education; 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.; Other: Community Navigation; 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.; Other: Healthcare Providers Educational Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Up to 6 months

Other Outcome Measures

Outcome Measure	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.	Up to 6-months

Collaborators and Investigators

• Sponsor: University of Puerto Rico Comprehensive Cancer Center
• Investigators: Principal Investigator: Vivian Colon Lopez, PhD, MPH, UPR-Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; Puerto Rico; FQHC; cancer screening overdue
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2409000060; SUB-OTA No. 6922-03-COVID-S026 (Other Grant/Funding Number: WESTAT, INC.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No