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

NCT ID: NCT05900544

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2029-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Disease Emphysema or COPD Breast Density

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Quasi-experimental
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Implementation

New lung cancer screening participants with clinically significant incidental findings received new patient-centered report

Group Type EXPERIMENTAL

System implementation of patient-centered incidental findings report

Intervention Type OTHER

For three lung cancer screening programs a system level implementation for a patient-centered incidental findings report

Interventions

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System implementation of patient-centered incidental findings report

For three lung cancer screening programs a system level implementation for a patient-centered incidental findings report

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Montana

OTHER

Sponsor Role lead

Responsible Party

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Curtis Noonan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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25-0592-P0001

Identifier Type: -

Identifier Source: org_study_id