Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Primary Purpose
Coronary Disease, Emphysema or COPD, Breast Density
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
System implementation of patient-centered incidental findings report
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implementation
Arm Description
New lung cancer screening participants with clinically significant incidental findings received new patient-centered report
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05900544
Brief Title
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Official Title
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2024 (Anticipated)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
March 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Montana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Emphysema or COPD, Breast Density
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implementation
Arm Type
Experimental
Arm Description
New lung cancer screening participants with clinically significant incidental findings received new patient-centered report
Intervention Type
Other
Intervention Name(s)
System implementation of patient-centered incidental findings report
Intervention Description
For three lung cancer screening programs a system level implementation for a patient-centered incidental findings report
Primary Outcome Measure Information:
Title
Precaution Adoption Process Model (PAPM) health behavior stage
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
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