search
Back to results

Testing Informed Decision Making in Lung Cancer Screening (TIDiL)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision Making
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer

Eligibility Criteria

55 Years - 78 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2021
Last Updated
September 7, 2023
Sponsor
Christiana Care Health Services
Collaborators
Thomas Jefferson University, University of Delaware, National Institute of General Medical Sciences (NIGMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT04940221
Brief Title
Testing Informed Decision Making in Lung Cancer Screening
Acronym
TIDiL
Official Title
Testing Informed Decision Making in Lung Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christiana Care Health Services
Collaborators
Thomas Jefferson University, University of Delaware, National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone-delivered decision-counseling program for shared decision making in lung cancer screening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making
Intervention Description
Telephone delivered non-persuasive shared decision-making for lung cancer screening.
Primary Outcome Measure Information:
Title
Number of Patients Who Received a Low Dose CT Scan of the Chest
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather B Fagan, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Pending data analytic support to de-identify data, will share entire study data.

Learn more about this trial

Testing Informed Decision Making in Lung Cancer Screening

We'll reach out to this number within 24 hrs