Clinical trial · Interventional
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
NCT05900544CI-TRIAL-00083470withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not funded by AHRQ
Summary
Brief summary (as posted)
The investigators will implement a patient-centered outcomes tool for participants in lung cancer screening programs that receive clinically important incidental findings relevant to heart, breast and lung health. The study objective is to evaluate participant response and clinical follow-up following implementation of a patient-centered incidental findings communication tool.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Density | — | UNRESOLVED | — |
| Coronary Disease | — | UNRESOLVED | — |
| Emphysema or COPD | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| System implementation of patient-centered incidental findings report | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Implementation
- description
- New lung cancer screening participants with clinically significant incidental findings received new patient-centered report
- interventionNames
- Other: System implementation of patient-centered incidental findings report
Primary outcomes (1)
- measure
- Precaution Adoption Process Model (PAPM) health behavior stage
- timeFrame
- 3 years
- description
- The PAPM is a theoretical, stages of change model that, in conjunction with the Health Belief model, has been used to guide the study of health behaviors, including to promote screening for health conditions. The PAPM outlines seven stages along a continuum toward health behavior change: (1) unaware of the health behavior, (2) aware but unengaged with the health behavior, (3) engaged and thinking about acting (deciding), (4) decided not to act, (5) decided to act (but not yet acting), (6) acting, and (7) maintenance of the health behavior. Using a questionnaire, we will capture the participants' stage of change before and after implementation of the incidental findings communication tool. The desired directionality of change is a higher stage with 7 being the maximum score and 1 being the minimum score.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible for lung cancer screening program * Presence of one of three incidental findings on low dose CT: coronary artery calcification, extensive breast density (for females), or emphysema Exclusion Criteria: * No incidental findings from lung cancer screening low dose CT
References
Publications (0)
Data not yet available
No reference posted for this study.