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

NCT07231159 | Recruiting

• 2 other identifiers: 2343026333
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Lung Cancer (Diagnosis); Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The categorization of the RE-AIM model dimensions of Reach, Effectiveness, Adoption, Implementation, and Maintenance,

  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 Outcomes (2)

• PROMIS Global Health (HR-QoL) scale

  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)

  From enrollment to the end of the 3 month follow-up for a total of 12 months

Study Arms (2)

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

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

Interventions

referral for definitive diagnosis based on their cancer screening results BEHAVIORAL

Need for radiological diagnosis

community-based initiative for screening, diagnosis, and treatment of breast, lung, and prostate

Engagement BEHAVIORAL

Engage in stakeholder focus groups to provide feedback about program operations

Recruitment of Stakeholder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Resource Spots, Emergency Departments and Urgent Care Centers

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead
• Florida Department of Health: collaborator

Study Sites (1)

Adventhealth

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (7)

• Kumar AJ, Banco D, Steinberger EE, Chen J, Weidner R, Makim S, Parsons SK. Time to diagnostic resolution after an uncertain screening mammogram in an underserved population. Cancer Med. 2020 May;9(9):3252-3258. doi: 10.1002/cam4.2970. Epub 2020 Mar 11.

  PMID: 32160406 BACKGROUND

• Holtrop JS, Rabin BA, Glasgow RE. Qualitative approaches to use of the RE-AIM framework: rationale and methods. BMC Health Serv Res. 2018 Mar 13;18(1):177. doi: 10.1186/s12913-018-2938-8.

  PMID: 29534729 BACKGROUND

• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

  PMID: 19543809 BACKGROUND

• Carle AC, Jean-Pierre P, Winters P, Valverde P, Wells K, Simon M, Raich P, Patierno S, Katz M, Freund KM, Dudley D, Fiscella K. Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. Med Care. 2014 Apr;52(4):354-61. doi: 10.1097/MLR.0000000000000089.

  PMID: 24848207 BACKGROUND

• Chen M, Wu VS, Falk D, Cheatham C, Cullen J, Hoehn R. Patient Navigation in Cancer Treatment: A Systematic Review. Curr Oncol Rep. 2024 May;26(5):504-537. doi: 10.1007/s11912-024-01514-9. Epub 2024 Apr 6.

  PMID: 38581470 RESULT

• Braun, V., Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101

  RESULT

• Bell-Brown A, Watabayashi K, Delaney D, Carlos RC, Langer SL, Unger JM, Vaidya RR, Darke AK, Hershman DL, Ramsey SD, Shankaran V. Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics. JNCI Cancer Spectr. 2023 Aug 31;7(5):pkad055. doi: 10.1093/jncics/pkad055.

  PMID: 37561111 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Disease; Prostatic Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Mark Socinski, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Robinson, PhD

CONTACT

407-303-3286; patricia.robinson@adventhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)