Trial Outcomes & Findings for Testing Informed Decision Making in Lung Cancer Screening (NCT NCT04940221)

Last Updated: 2023-09-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

1 year

Results posted on

2023-09-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Informed Decision Making in Lung Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening n=80 Participants 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.
Age, Continuous	64.1 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
pack-years	45.6 (packs/day)*years STANDARD_DEVIATION 16.1 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening n=80 Participants 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.
Number of Patients Who Received a Low Dose CT Scan of the Chest	18 Participants

Adverse Events

Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Bittner Fagan, MD MPH

Christiana Care Health System

Phone: 302 320 4110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place