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Active Mammography and Counseling

Monitoreo Activo de Mamografía y Orientación

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07238088
Acronym
MAMO
Enrollment
1020
Registered
2025-11-20
Start date
2026-01-26
Completion date
2028-02-28
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Prevention

Keywords

breast cancer, Puerto Rico, cancer screening overdue, FQHC

Brief summary

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.

Interventions

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.

OTHERHealthcare 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.

Sponsors

University of Puerto Rico Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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 two years:

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who self-reported having had a mammogramUp to 12 monthsParticipants will receive follow-up calls and emails every 3 months for one year 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

MeasureTime frameDescription
Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration LevelsUp to 12 monthsThe 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

MeasureTime frameDescription
Changes in the patient-provider communication satisfaction considering intervention level: the Educational, Navigation, and Integration LevelsUp to 12 monthsPatient-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.

Contacts

Primary ContactDiana T Medina Laabes, MS, CRC
dmedina@cccupr.org787-772-8300
Backup ContactKarelys Canales, MPHE, CHES
kcanales@cccupr.org787-772-8300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026