Testing Informed Decision Making in Lung Cancer Screening

NCT ID: NCT04940221

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2020-10-30

Brief Summary

Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.

Detailed Description

Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Phone-delivered decision-counseling program for shared decision making in lung cancer screening

All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group.

Group Type: EXPERIMENTAL

Shared Decision Making

Intervention Type: BEHAVIORAL

Telephone delivered non-persuasive shared decision-making for lung cancer screening.

Interventions

Shared Decision Making

Telephone delivered non-persuasive shared decision-making for lung cancer screening.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current or former smoker
• Greater than or equal to 30 pack years smoking

Exclusion Criteria

• Prior CT in last year
• Quit smoking greater than 15 years ago
• Current diagnosis of lung cancer

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Heather Bittner Fagan

Physician - Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather B Fagan, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Christiana Care Health System

Newark, Delaware, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54GM104941

Identifier Type: NIH

Identifier Source: secondary_id

View Link

603913

Identifier Type: -

Identifier Source: org_study_id