PR-CEAL: Community Outreach Engagement Group

NCT07214051 | Completed

• 2 other identifiers: 2410002304SUB-OTA No. 6922-03-COVID-S026
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Prevention; Colorectal Cancer Prevention; Cervical Cancer Prevention

Keywords

Breast Cancer Screening Test; Colorectal Cancer Screening Test; Cervical Cancer Screening Test; Puerto Rico; overdue cancer screening

Outcome Measures

Primary Outcomes (1)

• 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).

  Eight weeks

Secondary Outcomes (1)

• Number of participants that scheduled an appointment for cancer screening

  Eight weeks

Study Arms (2)

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.

Behavioral: Cancer Screening Information

Interventions

Cancer Screening Information BEHAVIORAL

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.

Cancer Screening Information

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Puerto Rico Comprehensive Cancer Center: lead

Study Sites (1)

University of Puerto Rico, Comprehensive Cancer Center

San Juan, PR, 00926, Puerto Rico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study recruited 500 participants, allocated on 1:1 ratio for intervention or control group.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 9, 2025
• Study Start: December 13, 2023
• Primary Completion: July 12, 2024
• Study Completion: August 30, 2024
• Last Updated: October 9, 2025

Record last verified: 2025-09

Locations

PR (1)