Recruiting

Observational Study

Sponsor:

AdventHealth

Code:

NCT07231159

Conditions

Breast Cancer

Lung Cancer (Diagnosis)

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

referral for definitive diagnosis based on their cancer screening results

Engagement

Study Details

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

Study ID

NCT07231159

Start date

Nov 17, 2025

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

referral for definitive diagnosis based on their cancer screening results

Need for radiological diagnosis

Engagement

Engage in stakeholder focus groups to provide feedback about program operations

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 ]

Central Contacts and Locations

Central contacts

Patricia Robinson, PhD

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

Locations

Adventhealth

Recruiting

Orlando, Florida, United States, 32804

More Information

Sponsor

AdventHealth

Last update posted

Nov 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2025-11-17.