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Testing Informed Decision Making in Lung Cancer Screening

Testing Informed Decision Making in Lung Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04940221
Acronym
TIDiL
Enrollment
80
Registered
2021-06-25
Start date
2018-07-18
Completion date
2020-10-30
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

BEHAVIORALShared Decision Making

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

Sponsors

Thomas Jefferson University
CollaboratorOTHER
University of Delaware
CollaboratorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Christiana Care Health Services
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 78 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Who Received a Low Dose CT Scan of the Chest1 yearPercentage 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.

Countries

United States

Participant flow

Recruitment details

We identified 1359 individuals in our electronic medical record data who appeared to be current smokers within the age range of 55-78 years old. From this group, 1073 remained potentially eligible after chart review. From this group, 336 were reached by phone. From this group, 80 individuals were eligible and consented to be in our study.

Participants by arm

ArmCount
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. Shared Decision Making: Telephone delivered non-persuasive shared decision-making for lung cancer screening.
80
Total80

Baseline characteristics

CharacteristicPhone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening
Age, Continuous64.1 years
STANDARD_DEVIATION 6
Ethnicity (NIH/OMB)
Hispanic or Latino
79 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
pack-years45.6 (packs/day)*years
STANDARD_DEVIATION 16.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
14 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
66 Participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
40 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 80
other
Total, other adverse events
0 / 80
serious
Total, serious adverse events
0 / 80

Outcome results

Primary

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.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer ScreeningNumber of Patients Who Received a Low Dose CT Scan of the Chest18 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026