Coronary Disease Clinical Trial
Official title:
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Verified date | June 2023 |
Source | University of Montana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | March 2029 |
Est. primary completion date | October 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Montana |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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