Active Mammography and Counseling

NCT07238088 | Recruiting

• 2 other identifiers: 2409000060SUB-OTA No. 6922-03-COVID-S026
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Prevention

Keywords

breast cancer; Puerto Rico; cancer screening overdue; FQHC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 6 months

Other Outcomes (1)

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

  Up to 6-months

Study Arms (3)

Educational Level

EXPERIMENTAL

Individual educational component

Behavioral: Individual Education

Navigation Level

EXPERIMENTAL

Behavioral: Individual Education; Other: Community Navigation

Integration level

EXPERIMENTAL

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

Interventions

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.

Educational Level; Integration level; Navigation Level

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.

Integration level; Navigation Level

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.

Integration level

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Puerto Rico Comprehensive Cancer Center: lead

Study Sites (1)

UPR-Comprehensive Cancer Center

San Juan, 00959, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vivian Colon Lopez, PhD, MPH

  UPR-Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana T Medina Laabes, MS, CRC

CONTACT

787-772-8300; dmedina@cccupr.org

Karelys Canales, MPHE, CHES

CONTACT

787-772-8300; kcanales@cccupr.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Lead & Associate Director

Model Details: 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 12 months.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 20, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

PR (1)