Breast Cancer PreventionMAMONCT07238088
Active Mammography and Counseling
A study testing Individual Education, Community Navigation and Healthcare Providers Educational Intervention in people with Breast Cancer Prevention, run by University of Puerto Rico Comprehensive Cancer Center at 1 site in Puerto Rico.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention
- What is being tested?
- Individual Education, Community Navigation and Healthcare Providers Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 14 Jan 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site, 1 recruiting
- Recruiting
UPR-Comprehensive Cancer Center
San Juan, 00959
Diana T Medina Laabes, MS, 7877728300 ext. 5911, dmedina@cccupr.org
About this study
Official title: 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.
- Conditions
- Breast Cancer Prevention
- Being tested
- Individual Education, Community Navigation, Healthcare Providers Educational Intervention
- Keywords
- breast cancer, Puerto Rico, cancer screening overdue, FQHC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual EducationBehavioural
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 NavigationOther
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Level | Experimental | Individual educational component Receives: Behavioral: Individual Education |
| Navigation Level | Experimental | Not described Receives: Behavioral: Individual Education; Other: Community Navigation |
| Integration level | Experimental | Not described Receives: Behavioral: Individual Education; Other: Community Navigation; Other: Healthcare Providers Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start14 Jan 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 12 months.
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Colon Lopez, University of Puerto Rico Comprehensive Cancer Center
- Investigators
- Vivian Colon Lopez, PhD, MPH, Principal investigator, UPR-Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238088
- Sponsor's protocol ID
- 2409000060
- Other IDs
- SUB-OTA No. 6922-03-COVID-S026
- Acronym
- MAMO
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoreo Activo de Mamografía y Orientación
- ClinicalTrials.gov ID
- NCT07238088
- Acronym / sponsor ID
- MAMO / 2409000060
- Conditions
- Breast Cancer Prevention
- Keywords
- breast cancer, Puerto Rico, cancer screening overdue, FQHC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- University of Puerto Rico Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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 12 months.
| Arm | Type | Receives |
|---|---|---|
| Educational Level | Experimental | Behavioral: Individual EducationIndividual educational component |
| Navigation Level | Experimental | Behavioral: Individual Education, Other: Community Navigation |
| Integration level | Experimental | Behavioral: Individual Education, Other: Community Navigation, Other: Healthcare Providers Educational Intervention |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual EducationThis 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. | Behavioural | Educational Level, Integration level, Navigation Level |
| Community NavigationAt 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 | Integration level, Navigation Level |
| Healthcare Providers Educational InterventionThe 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. | Other | Integration level |
Primary outcome
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.
1 secondary outcome
Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vivian Colon Lopez, PhD, MPH principal investigator
UPR-Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Education, Community Navigation and Healthcare Providers Educational Intervention in people with Breast Cancer Prevention, run by University of Puerto Rico Comprehensive Cancer Center at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana T Medina Laabes, MS, CRC (787-772-8300 ext. 5911, dmedina@cccupr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who self-reported having had a mammogram (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.