Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots

November 14, 2025 updated by: AdventHealth
To evaluate a community-based outreach initiative for screening, diagnosis, and treatment of breast, lung, and prostate cancers in underserved adults using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) implementation science framework.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Community Resource Spots, Emergency Departments and Urgent Care Centers

Description

Inclusion Criteria:

  1. Adult aged 18 or older
  2. Seeking care at a CRS or emergency department

  3. Meets criteria for lung, breast, and/or prostate cancer screening, as outlined below:

    1. Lung cancer: Adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years
    2. Breast cancer: Women aged 40 to 74 years
    3. Prostate cancer: Men aged 55 to 69 years
  4. Receives a positive screening result for lung, breast, and/or prostate cancer at a study site

Exclusion Criteria:

  1. Displays behavior disruptive to other patients or staff
  2. Refusal to accept screening for breast, lung, and/or prostate cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
community-based initiative for screening, diagnosis, and treatment of breast, lung, and prostate
Identify differences between adults who accept or decline cancer follow-up diagnosis and treatment, and clinical trial screening Identify barriers and facilitators to cancer screening, diagnosis, treatment, and clinical trial screening Understand perceptions towards navigators in the cancer care continuum
Behavioral: referral for definitive diagnosis based on their cancer screening results
Need for radiological diagnosis
Recruitment of Stakeholder
Investigators will establish relationships with community stakeholders, providers, and other key personnel to inform them of the program, the study, and opportunities to engage in stakeholder focus groups to provide feedback about program operations. For those interested in participating, a study team member will explain the study and the requirements for participation, review the informed consent form in detail, and obtain consent.
Behavioral: Engagement
Engage in stakeholder focus groups to provide feedback about program operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The categorization of the RE-AIM model dimensions of Reach, Effectiveness, Adoption, Implementation, and Maintenance,
Time Frame: From enrollment to the end of the 3 month follow-up for a total of 12 months

Reach will assess the percentage and characteristics of patients screened or excluded, as well as participant versus non-participant profiles.

Effectiveness will measure the proportion of positive screens referred for confirmatory diagnostics and compare screening rates to Healthy People 2030 goals.

Adoption will track provider education on breast, lung, and prostate cancer screening guidelines, uptake of screening practices, and staff engagement with navigation programs.

Implementation will evaluate referrals to navigation, screening rates, and for positive screens: referral time, diagnostic barriers, treatment uptake, and clinical trial screening.

Maintenance will examine primary outcomes at three months, progress toward HP2030 goals, attrition rates, and differences by patient characteristics.
From enrollment to the end of the 3 month follow-up for a total of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Global Health (HR-QoL) scale
Time Frame: From enrollment to the end of the 3 month follow-up for a total of 12 months
A 10-item scale to assess physical, mental, and social health on a scale of 5 (Excellent) to 1 (Poor), ability to carry out everyday activities on a scale of 5 (Completely) to 1 (Not at all), emotional problems on a scale of 5 (Never) to 1 (Always), fatigue on a scale of 5 (None) to 1 (Very severe), and pain on a scale of 0 (No pain) to 10 (Worst imaginable pain)
From enrollment to the end of the 3 month follow-up for a total of 12 months
Patient Satisfaction with Logistical Aspects of Navigation Scale (PSN-L)
Time Frame: From enrollment to the end of the 3 month follow-up for a total of 12 months
A 26-item scale to assess satisfaction with the navigation program on a scale of 3 (Very satisfied) to 1 (Not Satisfied)
From enrollment to the end of the 3 month follow-up for a total of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Florida Department of Health

Investigators

  • Principal Investigator: Mark Socinski, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 17, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2343026
  • 333 (Other Grant/Funding Number: Florida Department of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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