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

Sponsor

University of Montana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05900544

Collaborator

(none)

300

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Emphysema or COPD Breast Density	Other: System implementation of patient-centered incidental findings report	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Quasi-experimentalQuasi-experimental

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implementation New lung cancer screening participants with clinically significant incidental findings received new patient-centered report	Other: 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

Arm

Intervention/Treatment

Experimental: Implementation

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

Other: 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

Outcome Measures

Primary Outcome Measures

Precaution Adoption Process Model (PAPM) health behavior stage [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Montana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Curtis Noonan, Principal Investigator, University of Montana

ClinicalTrials.gov Identifier:

NCT05900544

Other Study ID Numbers:

25-0592-P0001

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Disease

Emphysema

Study Results

No Results Posted as of Jun 12, 2023