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NCT Number: NCT07231159

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lung Cancer (Diagnosis) Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adventhealth

Orlando, Florida, 32804, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult aged 18 or older
  • Seeking care at a CRS or emergency department
  • Meets criteria for lung, breast, and/or prostate cancer screening, as outlined below:
  • 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
  • Breast cancer: Women aged 40 to 74 years
  • Prostate cancer: Men aged 55 to 69 years
  • Receives a positive screening result for lung, breast, and/or prostate cancer at a study site

Exclusion criteria

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

Treatment and study plan

referral for definitive diagnosis based on their cancer screening results

Behavioral

Need for radiological diagnosis

Engagement

Behavioral

Engage in stakeholder focus groups to provide feedback about program operations

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Robinson, PhD

CONTACT

[email protected]

407-303-3286

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Florida Department of Health

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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