Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult aged 18 or older
Seeking care at a CRS or emergency department
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
Disqualifiers
Displays behavior disruptive to other patients or staff
Refusal to accept screening for breast, lung, and/or prostate cancers
Trial population
Community Resource Spots, Emergency Departments and Urgent Care Centers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
referral for definitive diagnosis based on their cancer screening results
BehavioralNeed for radiological diagnosis
Engagement
BehavioralEngage in stakeholder focus groups to provide feedback about program operations
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: community-based initiative for screening, diagnosis, and treatment of breast, lung, and prostate1 intervention
Group B: Recruitment of Stakeholder1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of the 3 month follow-up for a total of 12 monthsSecondary outcomes
1
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)
Time frame
From enrollment to the end of the 3 month follow-up for a total of 12 months2
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)
Time frame
From enrollment to the end of the 3 month follow-up for a total of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
AdventHealth
Lead sponsor
Florida Department of Health
Collaborator
Source ClinicalTrials.gov