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

NCT ID: NCT07231159

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-17

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Lung Cancer (Diagnosis) Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

referral for definitive diagnosis based on their cancer screening results

Intervention Type BEHAVIORAL

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.

Engagement

Intervention Type BEHAVIORAL

Engage in stakeholder focus groups to provide feedback about program operations

Interventions

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referral for definitive diagnosis based on their cancer screening results

Need for radiological diagnosis

Intervention Type BEHAVIORAL

Engagement

Engage in stakeholder focus groups to provide feedback about program operations

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida Department of Health

OTHER_GOV

Sponsor Role collaborator

AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Socinski, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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Adventhealth

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Robinson, PhD

Role: CONTACT

407-303-3286

References

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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.

Reference Type BACKGROUND
PMID: 32160406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29534729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19543809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24848207 (View on PubMed)

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.

Reference Type RESULT
PMID: 38581470 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT
PMID: 37561111 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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333

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2343026

Identifier Type: -

Identifier Source: org_study_id

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