Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures

NCT05900544 | Withdrawn

• 1 other identifier: 25-0592-P0001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Coronary Disease; Emphysema or COPD; Breast Density

Outcome Measures

Primary Outcomes (1)

• Precaution Adoption Process Model (PAPM) health behavior stage

  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.

  3 years

Study Arms (1)

Implementation

EXPERIMENTAL

New lung cancer screening participants with clinically significant incidental findings received new patient-centered report

Other: System implementation of patient-centered incidental findings report

Interventions

System implementation of patient-centered incidental findings report OTHER

For three lung cancer screening programs a system level implementation for a patient-centered incidental findings report

Implementation

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No incidental findings from lung cancer screening low dose CT

Sponsors & Collaborators

• University of Montana: lead

MeSH Terms

Conditions

Coronary Disease; Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi-experimental

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 12, 2023
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 9, 2024

Record last verified: 2024-12