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| ID | Type | Description | Link |
|---|---|---|---|
| 333 | Other Grant/Funding Number | Florida Department of Health |
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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| referral for definitive diagnosis based on their cancer screening results | Behavioral | Need for radiological diagnosis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Global Health (HR-QoL) scale | 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) |
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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:
Receives a positive screening result for lung, breast, and/or prostate cancer at a study site
Exclusion Criteria:
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Community Resource Spots, Emergency Departments and Urgent Care Centers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Robinson, PhD | Contact | 407-303-3286 | patricia.robinson@adventhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Socinski, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adventhealth | Recruiting | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32160406 | Background | 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. | |
| 29534729 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2025 | Sep 12, 2025 |
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| Engagement | Behavioral | Engage in stakeholder focus groups to provide feedback about program operations |
|
| 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) | 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 |
| 19543809 | 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. |
| 24848207 | 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. |
| 38581470 | Result | 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. |
| Result | Braun, V., Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101 |
| 37561111 | 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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