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NCT Number: NCT07238088

Active Mammography and Counseling

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.

Recruiting

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPR-Comprehensive Cancer Center

San Juan, 00959, Puerto Rico

Location status: Recruiting

Location contact

Diana T Medina Laabes, MS

CONTACT

[email protected]

7877728300 ext. 5911

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Number of participants who self-reported having had a mammogram

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels

    Time frame: Up to 6 months

    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.

Other outcomes

  1. Changes in the patient-provider communication satisfaction considering intervention level: the Educational, Navigation, and Integration Levels

    Time frame: Up to 6-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana T Medina Laabes, MS, CRC

CONTACT

[email protected]

787-772-8300 ext. 5911

Karelys Canales, MPHE, CHES

CONTACT

[email protected]

787-772-8300 ext. 1154

Sponsors and collaborators

Lead sponsor

University of Puerto Rico Comprehensive Cancer Center

Other

Registry information

Official study title

Monitoreo Activo de Mamografía y Orientación

Acronym: MAMO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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