Breast Cancer PreventionPR-CEAL:COEGNCT07214051
PR-CEAL: Community Outreach Engagement Group
A study testing Cancer Screening Information in people with Breast Cancer Prevention and Colorectal Cancer Prevention, run by University of Puerto Rico Comprehensive Cancer Center at 1 site in Puerto Rico.
Trial summary
The United States Preventive Services Task Force (USPSTF) recommends regular screenings for breast, cervical, and colorectal cancer. The COVID-19 pandemic has disrupted health screening practices, leading to a decrease in cancer screenings among the United States including Puerto Rico. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention, Colorectal Cancer Prevention, Cervical Cancer Prevention
- What is being tested?
- Cancer Screening Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 13 Dec 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Between 21 and 75 years old
- Participant is overdue in at least one cancer screening (breast, cervical or colorectal), according to the USPTF guidelines.
- Participants that have not reported any cognitive, mental or physical limitation.
- Ability to read.
- Access to a telephone.
- Participants that are not in active cancer treatment.
Who cannot join
- Male
- Women younger than 21 years or older than 75 years.
- Participants that are not overdue in any cancer screening (breast, cervical or colorectal), according to the USPTF guidelines.
- Participants that are cognitive, mental or physically limited.
- Participants who are not able to read.
- Participants who don't have access to a telephone.
- Participants that are in active cancer treatment.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico, Comprehensive Cancer Center
San Juan, PR, 00926
About this study
The United States Preventive Services Task Force (USPSTF) recommends regular screenings for breast, cervical, and colorectal cancer. The COVID-19 pandemic has disrupted health screening practices, leading to a decrease in cancer screenings among the United States including Puerto Rico. This has been attributed to unwillingness, distrust, and insecurity related to accessing healthcare services. To overcome these challenges, a collaboration between PR-CEAL's Community Outreach Engagement Group (COEG), academic researchers, healthcare institutions, and community-based organizations proposed to engage in different community activities throughout the island. In these events, investigators conducted a single blinded community-based Randomized Clinical Trial (RCT) regarding cancer screening practices in women 21 through 75 years. The community-based RCT employed a mixed-method design to gain insights into the perception of health and cancer screening status of participants regarding breast, uterine (cervical), and colorectal cancer. Data was collected through in person interviews and two follow up phone calls, enabling the researchers to obtain valuable sociodemographic information, assessing cancer screening history, and identifying existing barriers.
The hypothesis of this study is that implementing evidence-based intervention at community settings across Puerto Rico will have a significant positive effect on cancer screening rates among non-adherent patients. By identifying and adapting the Prevention Care Management for Cancer Screening intervention and leveraging the expertise of the National Cancer Institute, the study aimed to improve screening rates, address barriers that hinder or delay screenings, and raise awareness about the importance of early detection.
Read the detailed description
The study aimed to recruit 500 participants. Recruited participants were women aged 21 through 75 years, overdue in at least one cancer screening test (breast cancer, cervical cancer, and/or colorectal cancer) based on the US Preventive Services Task Force (USPSTF) guidelines. Once the woman verbally consents to participate in the RCT, four pre-screening questions and a Cancer Screening Module will be conducted to determine her eligibility. If the woman is eligible, informed consent will be completed, followed by a contact information module, and a baseline survey using an adaptation of the Prevention Care Management approach.
After identifying overdue participants and obtaining their RCT participation consent, REDcap randomly assigned them to control or intervention groups in a 1:1 ratio. The control group (n=250) received physical activity and mindfulness materials, while the intervention group (n=250) received educational materials that included screening center details and reminders related to cancer screening. Two follow-up calls, at four-week intervals, were performed to assess the screening status for all participants.
- If the initial call was unanswered, two more attempts were made on consecutive days. Voicemails, if possible, will prompt a response. A second follow-up call was made four weeks later to evaluate the status.
- If a participant answers the initial call but remains unscreened, Health Promoter encourages the intervention group to schedule doctor visits and cancer screening appointments. The second follow-up call in four weeks assesses the status. If the initial call is unanswered, two more attempts follow. Voicemails may be used to prompt a response.
- If the participant answered the initial call and has an appointment for cancer screening, a second follow-up call in four weeks will assess screening status. If the initial call was unanswered, two more attempts were made. Voicemails were used to prompt a response.
- The intervention ended if the participant confirmed an up-to-date status in the initial call.
Once the study concluded, the control group received the cancer educational materials by mail.
- Being tested
- Cancer Screening Information
- Keywords
- Breast Cancer Screening Test, Colorectal Cancer Screening Test, Cervical Cancer Screening Test, Puerto Rico, overdue cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Screening InformationBehavioural
The intervention group (n=250) received educational materials that included: screening center details, and reminders related to cancer screening. Two follow-up calls, at four-week intervals each, assessed screening status for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity and Mental Health Information | No intervention | The control group (n=250) received physical activity and mindfulness materials. Two follow-up calls, at four- week intervals each, assessed screening status for all participants. Once the study concluded, cancer information was sent to participants by certified mail. |
| Cancer Screening Information | Experimental | The intervention group (n=250) received educational materials that included: screening center details, and reminders related to cancer screening. Two follow-up calls, at four-week intervals each, assessed screening status for all participants. Receives: Behavioral: Cancer Screening Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who compelled with cancer screening test
Once recruited, participants have two follow-up calls at four-week intervals each to assess their cancer screening test status (i.e., whether they have had their mammograms, pap test, and FOBT or colonoscopy).
Measured: Eight weeks
Secondary outcomes (1)
Number of participants that scheduled an appointment for cancer screening
Once recruited, participants have two follow-up calls at four-week intervals each to assess the scheduling of an appointment for their cancer screening test.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start13 Dec 2023
- Primary completion12 Jul 2024
- Study completion30 Aug 2024
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
- Parallel groups
- Model description
- This study recruited 500 participants, allocated on 1:1 ratio for intervention or control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214051
- Sponsor's protocol ID
- 2410002304
- Other IDs
- SUB-OTA No. 6922-03-COVID-S026
- Acronym
- PR-CEAL:COEG
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PR-CEAL: Community Outreach Engagement Group
- ClinicalTrials.gov ID
- NCT07214051
- Acronym / sponsor ID
- PR-CEAL:COEG / 2410002304
- Keywords
- Breast Cancer Screening Test, Colorectal Cancer Screening Test, Cervical Cancer Screening Test, Puerto Rico, overdue cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Puerto Rico Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 9 Oct 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 United States Preventive Services Task Force (USPSTF) recommends regular screenings for breast, cervical, and colorectal cancer. The COVID-19 pandemic has disrupted health screening practices, leading to a decrease in cancer screenings among the United States including Puerto Rico. This has been attributed to unwillingness, distrust, and insecurity related to accessing healthcare services. To overcome these challenges, a collaboration between PR-CEAL's Community Outreach Engagement Group (COEG), academic researchers, healthcare institutions, and community-based organizations proposed to engage in different community activities throughout the island. In these events, investigators conducted a single blinded community-based Randomized Clinical Trial (RCT) regarding cancer screening practices in women 21 through 75 years. The community-based RCT employed a mixed-method design to gain insights into the perception of health and cancer screening status of participants regarding breast, uterine (cervical), and colorectal cancer. Data was collected through in person interviews and two follow up phone calls, enabling the researchers to obtain valuable sociodemographic information, assessing cancer screening history, and identifying existing barriers.
The hypothesis of this study is that implementing evidence-based intervention at community settings across Puerto Rico will have a significant positive effect on cancer screening rates among non-adherent patients. By identifying and adapting the Prevention Care Management for Cancer Screening intervention and leveraging the expertise of the National Cancer Institute, the study aimed to improve screening rates, address barriers that hinder or delay screenings, and raise awareness about the importance of early detection.
Detailed description
The study aimed to recruit 500 participants. Recruited participants were women aged 21 through 75 years, overdue in at least one cancer screening test (breast cancer, cervical cancer, and/or colorectal cancer) based on the US Preventive Services Task Force (USPSTF) guidelines. Once the woman verbally consents to participate in the RCT, four pre-screening questions and a Cancer Screening Module will be conducted to determine her eligibility. If the woman is eligible, informed consent will be completed, followed by a contact information module, and a baseline survey using an adaptation of the Prevention Care Management approach.
After identifying overdue participants and obtaining their RCT participation consent, REDcap randomly assigned them to control or intervention groups in a 1:1 ratio. The control group (n=250) received physical activity and mindfulness materials, while the intervention group (n=250) received educational materials that included screening center details and reminders related to cancer screening. Two follow-up calls, at four-week intervals, were performed to assess the screening status for all participants.
- If the initial call was unanswered, two more attempts were made on consecutive days. Voicemails, if possible, will prompt a response. A second follow-up call was made four weeks later to evaluate the status.
- If a participant answers the initial call but remains unscreened, Health Promoter encourages the intervention group to schedule doctor visits and cancer screening appointments. The second follow-up call in four weeks assesses the status. If the initial call is unanswered, two more attempts follow. Voicemails may be used to prompt a response.
- If the participant answered the initial call and has an appointment for cancer screening, a second follow-up call in four weeks will assess screening status. If the initial call was unanswered, two more attempts were made. Voicemails were used to prompt a response.
- The intervention ended if the participant confirmed an up-to-date status in the initial call.
Once the study concluded, the control group received the cancer educational materials by mail.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study recruited 500 participants, allocated on 1:1 ratio for intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity and Mental Health Information | No intervention | –The control group (n=250) received physical activity and mindfulness materials. Two follow-up calls, at four- week intervals each, assessed screening status for all participants. Once the study concluded, cancer information was sent to participants by certified mail. |
| Cancer Screening Information | Experimental | Behavioral: Cancer Screening InformationThe intervention group (n=250) received educational materials that included: screening center details, and reminders related to cancer screening. Two follow-up calls, at four-week intervals each, assessed screening status for all participants. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Between 21 and 75 years old
- Participant is overdue in at least one cancer screening (breast, cervical or colorectal), according to the USPTF guidelines.
- Participants that have not reported any cognitive, mental or physical limitation.
- Ability to read.
Key exclusion criteria (7 listed)
- Male
- Women younger than 21 years or older than 75 years.
- Participants that are not overdue in any cancer screening (breast, cervical or colorectal), according to the USPTF guidelines.
- Participants that are cognitive, mental or physically limited.
- Participants who are not able to read.
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 |
|---|---|---|
| Cancer Screening InformationThe intervention group (n=250) received educational materials that included: screening center details, and reminders related to cancer screening. Two follow-up calls, at four-week intervals each, assessed screening status for all participants. | Behavioural | Cancer Screening Information |
Primary outcome
Number of participants who compelled with cancer screening test
Time frame: Eight weeks
Once recruited, participants have two follow-up calls at four-week intervals each to assess their cancer screening test status (i.e., whether they have had their mammograms, pap test, and FOBT or colonoscopy).
1 secondary outcome
Number of participants that scheduled an appointment for cancer screening
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Screening Information in people with Breast Cancer Prevention and Colorectal 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 7 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: finished, as of the sponsor's last update on 9 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who compelled with cancer screening test (time frame: Eight weeks). 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 9 Oct 2025.