Breast CancerNCT07231159
Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots
An observational study of Breast Cancer and Lung Cancer (Diagnosis), run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer (Diagnosis), Prostate Cancer
- What is being tested?
- referral for definitive diagnosis based on their cancer screening results and Engagement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 31 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Resource Spots, Emergency Departments and Urgent Care Centers
Who may be able to join
- 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
Who cannot join
- Displays behavior disruptive to other patients or staff
- Refusal to accept screening for breast, lung, and/or prostate cancers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Adventhealth
Orlando, Florida, 32804
About this study
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
- Being tested
- referral for definitive diagnosis based on their cancer screening results, Engagement
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Disease, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
referral for definitive diagnosis based on their cancer screening resultsBehavioural
Need for radiological diagnosis
EngagementBehavioural
Engage in stakeholder focus groups to provide feedback about program operations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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)
Measured: From enrollment to the end of the 3 month follow-up for a total of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start17 Nov 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Mark Socinski, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231159
- Sponsor's protocol ID
- 2343026
- Other IDs
- 333
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32160406Holtrop 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.
PubMed 29534729Hays 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.
PubMed 19543809Carle 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.
PubMed 24848207Chen 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.
PubMed 38581470Braun, V., Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101
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.
PubMed 37561111
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots
- ClinicalTrials.gov ID
- NCT07231159
- Acronym / sponsor ID
- 2343026
- Conditions
- Breast Cancer, Lung Cancer (Diagnosis), Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 17 Nov 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community-based initiative for screening, diagnosis, and treatment of breast, lung, and prostate | – | Behavioral: referral for definitive diagnosis based on their cancer screening resultsIdentify 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 | – | Behavioral: EngagementInvestigators 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Resource Spots, Emergency Departments and Urgent Care Centers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Displays behavior disruptive to other patients or staff
- Refusal to accept screening for breast, lung, and/or prostate cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| referral for definitive diagnosis based on their cancer screening resultsNeed for radiological diagnosis | Behavioural | community-based initiative for screening, diagnosis, and treatment of breast, lung, and prostate |
| EngagementEngage in stakeholder focus groups to provide feedback about program operations | Behavioural | Recruitment of Stakeholder |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 32160406Kumar 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.
- Background: PubMed 29534729Holtrop 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.
- Background: PubMed 19543809Hays 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.
- Background: PubMed 24848207Carle 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.
- Results publication: PubMed 38581470Chen 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.
- Results publicationBraun, V., Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101
- Results publication: PubMed 37561111Bell-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Socinski, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer (Diagnosis), run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Robinson, PhD (407-303-3286, patricia.robinson@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07231159, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.