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Clinical Trials/NCT05900544
NCT05900544
Withdrawn
N/A

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

University of Montana0 sites300 target enrollmentDecember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
University of Montana
Enrollment
300
Primary Endpoint
Precaution Adoption Process Model (PAPM) health behavior stage
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2024
End Date
March 2029
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Curtis Noonan

Principal Investigator

University of Montana

Eligibility Criteria

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

Outcomes

Primary Outcomes

Precaution Adoption Process Model (PAPM) health behavior stage

Time Frame: 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.

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