search
Back to results

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
University of Montana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 28, 2023
    Last Updated
    June 9, 2023
    Sponsor
    University of Montana
    search

    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

    We'll reach out to this number within 24 hrs