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Trial Title:
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
NCT ID:
NCT05900544
Condition:
Coronary Disease
Emphysema or COPD
Breast Density
Conditions: Official terms:
Coronary Disease
Emphysema
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Quasi-experimental
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
System implementation of patient-centered incidental findings report
Description:
For three lung cancer screening programs a system level implementation for a
patient-centered incidental findings report
Arm group label:
Implementation
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.
Criteria for 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
Gender:
All
Minimum age:
55 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
October 2024
Completion date:
March 2029
Lead sponsor:
Agency:
University of Montana
Agency class:
Other
Source:
University of Montana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900544
