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

Not Applicable

Withdrawn

• Conditions: Emphysema or COPD; Coronary Disease; Breast Density
• Interventions: Other: System implementation of patient-centered incidental findings report

• Registration Number: NCT05900544
• Lead Sponsor: University of Montana

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.

Detailed Description

A computer assisted personal interview survey will be administered by study personnel to capture information about perceived risk, cues to action and self-efficacy among lung cancer screening participants. Participants eligible for recruitment will have had incidental findings from the low dose CT: moderate to severe CAC, grade 3 or 4 breast density, moderate to severe emphysema, or multiple incidental findings. The interview-administered survey will be conducted by telephone with responses entered by study personnel into a REDCap database. The REDCap questionnaire will be adapted to a given patient's IF status. The survey questions will be based on the Health Belief Model that has been used effectively in the context of secondary prevention. For each participant the survey will be conducted before and after system level implementation of a patient-centered incidental findings communication tool.

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-12
• Status Verified: 2024-12
• Study Start: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2027-10
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implementation	System implementation of patient-centered incidental findings report	New lung cancer screening participants with clinically significant incidental findings received new patient-centered report

Primary Outcome Measures

Name	Time	Method
Precaution Adoption Process Model (PAPM) health behavior stage	3 years	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.