NCT05832177

Brief Summary

The Outreach Core (OC) of the Ponce Health Sciences University-Moffitt Cancer Center (PHSU-MCC) Partnership provides community outreach and education to improve cancer screening behaviors in our catchment area populations. The overall goal of the OC is to increase community cancer awareness, community engagement, and participation in cancer research and outreach in our catchment areas. Working closely with other Partnership cores and investigators, the team proposes to elevate and expand its activities to facilitate reciprocal communication between community members and partnership researchers through OC educational activities, training opportunities, supporting participant recruitment efforts, and incorporating the Community Advisory Panel (CAP) feedback on partnership research projects. Together with community members and Partnership researchers, the OC will increase cancer awareness, community engagement, and participation in cancer research in communities served by MCC (in FL) and PHSU (in PR) through the following three Specific Aims: Aim 1: To develop, deliver, and disseminate cancer education and outreach activities to our catchment area populations. The team will deliver cancer education to communities in PR and FL using evidence-based programs through multiple delivery strategies and reflecting partnership research priorities and topics of interest identified by community members. Aim 2: To enhance capacity for mutually beneficial research engagement to address cancer health priorities in our catchment areas. The team will facilitate communication between community members and partnership investigators (e.g., CAP Research Corner), support partnership research that is responsive to community needs (translational research), promote community participation in the partnership's research activities/projects, and train researchers and community members in community engagement principles. Aim 3: To expand the capacity to train community members as lay health promoters to deliver evidence-based cancer education programs in their communities. The team will train community members and community partners/organizations to deliver evidence-based cancer education (e.g., Cancer 101, OC activities) in their local communities.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2023Jul 2028

Study Start

First participant enrolled

March 22, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5.3 years

First QC Date

April 14, 2023

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (14)

  • Number of Participants that Complete the Cancer 101 Online Training Program

    Program completion data will be based upon whether individuals complete the modules and assessments

    At 15 Weeks from Start of Training Program

  • Number of Participants that Access the Cancer 101 Online Training Information Post Training

    Number of participants that access the online program after completing the online training program

    At 6 months Post Training Program

  • Changes in cancer-related knowledge and self-efficacy for providing health education

    Data will be based on self-reported assessments completed by Cancer 101 online program participants prior to starting the course and upon completion of the course

    Day 1 and upon completion of Cancer 101 Online Training program, 15 weeks

  • Number of participants that attend Latinos y el cáncer/Hablemos de cáncer symposia

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1

  • Number of participants that attend ¡Salud! Serie de Charlas events

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1

  • Number of participants that attend El Puente events

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1

  • Number of participants that access recordings of the Lunch and Learn podcast

    Data will be based on event tracking related to access to podcast recordings

    1 week after posting, 1 month after posting, 6 months after posting

  • Number of U54 partnership investigator participants that attend the Community Engagement (CE) Training Program

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1 and Day 3, at start of and upon completion of each Community Engagement Training Program workshop]

  • Number of community member participants that attend the Community Engagement (CE) Training Program

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1 and Day 2 of at start and upon completion of each Community Engagement Training Program]

  • Number of CAP meetings held per year and number of CAP members

    Data will be based on event tracking metrics for attendance

    Day 1

  • Number of Research Corner presentations presented at CAP meetings

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1

  • Number of trainees that complete the Community-based Training Program (CBTP) for Community Leaders and Stakeholders

    Data will be based on event tracking metrics for attendance and evaluation completion

    Day 1 and Day 3, at start of and upon completion of the Community-based Training Program)

  • Number of trainees that complete the Cancer 101 Stakeholders Program

    Data will be based on event tracking metrics for attendance and evaluation completion

    Upon completion of the Stakeholders Program, 15 weeks

  • Number of Cancer 101 Stakeholders Program trainees that complete CME credits

    Data will be based on event tracking metrics for CME completion

    Upon completion of the Stakeholders Program, 15 weeks

Study Arms (11)

Community Members who attend Cancer CientoUno (101) program

Community members who opt to participate in the online Cancer CientoUno (101) training program. They will be asked to complete a registration survey and the programs self-paced educational modules. At the start of the course, they will be asked to complete a brief survey. After every module, they will be asked to complete a brief survey. In addition, community members will be asked to complete a midterm survey and a 6-month follow up survey.

Behavioral: Cancer CientoUno (101) program

Community Members who Attend Symposium

Community members who opt to attend this symposium which will offer educational presentations focused on prevention, nutrition, clinical trials, and specific cancer types addressed in breakout sessions. Participants will be asked to complete a registration form and a post-event evaluation form.

Behavioral: Latinos y el cáncer/Hablemos de cáncer (Translation in English: Latinos and Cancer/Let's Talk About Cancer)

Community Members who Attend Charlas (Talks)

Community members who opt to attend these charlas (talks) which will offer education on a variety of cancer-related topics. The topics are selected in response to each event, given the community interest or need for a specific cancer-related topic. Participants will be asked to complete a registration form and a post-event evaluation form.

Behavioral: ¡Salud! Serie de Charlas (Translation in English: Health! Talk Series)

Community Members who Attend Presentations

Community members who opt to attend and researchers (including those from the PHSU-MCC U54 partnership) will participate in these presentations to generate a discussion about ongoing research and have an opportunity for community members learn and provide feedback on on-going and completed research projects. Presentations from El Puente events will occur in Spanish (in Puerto Rico and Florida) and in English (in Florida). Attendees will be asked to complete a registration form and a post-event evaluation.

Behavioral: Community/Researcher Forum: El Puente (Translation in English: The Bridge).

Community Members who Access Series of Virtual Lunch and Learn Podcasts

Community members will have access to a series of virtual Lunch and Learn podcasts, which will be 30-minute long, pre-recorded sessions in English and/or Spanish. Podcast sessions will cover updated cancer-relevant recommendations from the United States Preventive Services Task Force (USPSTF). Reach will be tracked with number of visits and/or other access metrics.

Behavioral: Lunch and Learn Updated Recommendations Series.

U54 Partnership Investigators

These CE workshops will be mandatory for all partnership researchers who receive U54 funding in the proposed renewal period including Full, Pilot, and Developmental projects. The CE workshops are aimed to increase researchers' knowledge about the best strategies to establish teamwork with community members to achieve mutual benefits and advance translational research in cancer.

Behavioral: Community Engagement (CE) Training Program for U54 Partnership Investigators

Lay Community Members

Lay community members will opt to participate in a 2-day CE workshop series. The goal is to include trained lay community members to actively participate in cancer prevention education and research. These activities will facilitate community-academic partnerships between the Partnership researchers and community members.

Behavioral: Community Engagement (CE) Training Program for Lay Community Members

Community Members who Join Community Advisory Panel (CAP)

The Community Advisory Panel (CAP) members will include individuals who are cancer survivors, family members/caregivers of cancer survivors, and/or representatives from healthcare, community- and faith-based organizations who are invited to join the CAP and accept the invitation. The PHSU-MCC Partnership utilizes a CAP to inform and guide overall outreach activities in PR and FL. Two CAPs, one at MCC and one at PHSU have been organized. Previous CAP members will be retained if interested and new CAP members added as needed.

Behavioral: Community Advisory Panels (CAP)

U54 Partnership Investigators and CAP Members

During standing CAP meetings, partnership investigators present their ongoing research to members of the CAPs. Researchers who receive U54 funding in the proposed renewal period including Full, Pilot, and Developmental projects can request CAP feedback on topics along the research continuum from concepts for new research projects, ideas for recruitment, or dissemination of fundings.

Behavioral: Research Corner

Community Leaders and Stakeholders

Community leaders from disadvantaged socioeconomic areas and Stakeholders of healthcare organizations with whom the Program has established previous collaborative relationships will participate in the CBTP. The stakeholders include nurses, community health educators, clinical social workers, among other healthcare professionals.

Behavioral: Community-based Training Program (CBTP) for Community Leaders and Stakeholders.

Stakeholders

Physicians, nurses, psychologists, and other stakeholders within the communities under the partnership umbrella will participate in the Cancer 101 Stakeholders program.

Behavioral: Integrate Cancer 101 into the Stakeholders Programs

Interventions

The Spanish version of Cancer 101 consists of several modules that address cancer control and prevention, risk factors, early detection and screening guidelines, cancer diagnosis and stages, cancer treatment, cancer and genetics, cancer and chronic disease, patient and caregiver support, HPV, biobanking, and clinical trials. All modules contain a written summary with learning objectives, a PowerPoint presentation, pre- and post-module evaluations with an answer sheet, a glossary, references, and supplemental resources. This program will occur on an ongoing basis.

Community Members who attend Cancer CientoUno (101) program

This is an educational and community outreach effort comprised of local charlas (talks) led by Hispanic/Latino healthcare professionals (e.g., the partnership Community Health Educator \[CHE\], topic experts) who provide education and answer questions about specific cancer topics. The charlas may be conducted in multiple modalities (in person, virtual, hybrid) and may be conducted in English and/or Spanish. At least three events will be held each year in the partnership locations.

Community Members who Attend Charlas (Talks)

The main goal of the El Puente annual event is to generate dialogue between community members and researchers about cancer treatment and cancer-focused research topics. During El Puente's presentations, researchers present their projects and data results to community members, allowing community members to react to the research, make suggestions, and express concerns.

Community Members who Attend Presentations

This is a virtual podcast that will discuss cancer-related recommendations and guidelines from the United States Preventive Services Task Force (USPSTF). The podcasts are pre-recorded, 30 minute long, and will be in English and/or Spanish. This podcast will be hosted by the Outreach Core (OC) CHE, and feature experts who will explain the updated recommendations and active steps that community members and providers can take to facilitate adherence. This activity will begin according to the project timeline

Community Members who Access Series of Virtual Lunch and Learn Podcasts

This is a series of 2 1/2-day CE workshops designed and delivered up to 20 partnership researchers (including faculty and junior investigators) delivered across four sessions per year (6 to 10 researchers per year). Each session includes two hours of lectures (didactic material) and one hour of practice activities (practical application of the theoretical content). Session topics will include CE: concepts and principles, theoretical roots, levels, and ethics. The OC team will provide educational materials and additional references in each session.

U54 Partnership Investigators

These CAPs work closely with the (CHE) to oversee the identification, development, and coordination of the outreach activities; provide advice on the development and implementation of community needs and assessments; provide guidance for recruitment and retention of research participants; and assist in the recruitment for educational events and research and vetting community educational materials and the content of protocols for research projects.

Community Members who Join Community Advisory Panel (CAP)
Research CornerBEHAVIORAL

The goal is to provide bidirectional communication between the community and researchers to increase CE strategies into cancer disparities research through periodic meetings between community members and researchers to discuss CE strategies, research recruitment strategies, dissemination strategies, among others.

U54 Partnership Investigators and CAP Members

The CBTP provides the opportunity to acquire knowledge to impart cancer prevention education (Cancer 101) and skills necessary to disseminate educational information (hands-on experiences through OC educational activities). This training will be provided in-person and remotely to increase participation. This activity will begin according to the project timeline.

Community Leaders and Stakeholders

This program will offer stakeholders a no-cost workshop of three credit hours to increase cancer prevention education among Hispanic/Latinos. CMEs will be provided virtually to increase participation. This activity will begin according to the project timeline.

Stakeholders

A series of two-day CE workshops designed and delivered to 30 lay community members over a four-year period (6 to 10 participants per year). The proposed CE workshops includes: 1) CE principles, 2) cancer prevention education principles, and 3) community-based promotion strategies for cancer prevention. This activity will begin according to the project timeline.

Lay Community Members

This is a biennial cancer symposium focused on cancer topics important to Hispanic/Latinos. This day-long event includes a plenary session and concurrent sessions where healthcare professionals present educational information about cancer, cancer prevention, early detection methods, and other related topics.

Community Members who Attend Symposium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community members who are physicians, nurses, psychologists, community health educators, and clinical social workers

You may qualify if:

  • Age 18 years or older
  • Any health status
  • Able to speak, read and write Spanish or English (some events are in Spanish, some are in English)
  • \[Cancer 101 Online Training Program, Lunch and Learn podcast, and Stakeholders Program only\]: Have access to the internet
  • Willing to complete the training modules and assessments \[Cancer 101 Online Training Program\]
  • Willing to complete registration, attendance logs, and evaluations, as applicable
  • \[Community Engagement Training Program, Research Corner only\]: be a researcher who received U54 funding in the proposed renewal period including Full, Pilot, and Developmental projects.
  • \[Stakeholders in the Community-based Training Program and Cancer 101 Stakeholders program only\]: nurses, community health educators, clinical social workers, physicians, psychologists, among other healthcare professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Ponce Health Sciences University

Ponce, 00716, Puerto Rico

RECRUITING

Related Links

MeSH Terms

Interventions

Protein BiosynthesisResidence CharacteristicsLunch

Intervention Hierarchy (Ancestors)

Peptide BiosynthesisBiochemical PhenomenaChemical PhenomenaMetabolismGene ExpressionGenetic PhenomenaDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shannon Christy, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Christy, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 27, 2023

Study Start

March 22, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations