Testing Informed Decision Making in Lung Cancer Screening (TIDiL)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Shared Decision Making

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Shared Decision Making; Telephone delivered non-persuasive shared decision-making for lung cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Received a Low Dose CT Scan of the Chest	Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance.	1 year

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: National Institute of General Medical Sciences (NIGMS); Thomas Jefferson University; University of Delaware
• Investigators: Principal Investigator: Heather B Fagan, MD, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 603913; U54GM104941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending data analytic support to de-identify data, will share entire study data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No