Lung Cancer Screening Eligibility Assessment

May 29, 2025 updated by: Katharine Rendle, Abramson Cancer Center at Penn Medicine

Using a Simplified Tool to Predict Lung Cancer Screening (LCS) Eligibility: Experiment to Test Effects of Messaging on Response Rates

The primary purpose of this study evaluate if different messaging impacts response rates to a brief survey (i.e., the simplified eligibility tool) that is designed to estimate pack-year eligibility for lung cancer screening (LCS). This will help inform the best way to increase response rates to the tool in future intervention studies designed to increase LCS, and expand upon survey methodology in general.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite growing evidence that lung cancer screening (LCS) reduces lung cancer-specific mortality, LCS across the United States is remarkably low. This is due in part to challenges with identifying adults who meet eligibility criteria for lifetime smoking intensity (i.e., 20 pack-years or greater), which is often missing from the electronic medical record. We have developed a simplified eligibility tool that has shown accuracy in estimating pack-years. But given the potential for low response rates, there is a great need to identify effective strategies to increasing response rates equitably prior to using it in practice or in future studies. The primary purpose of this study evaluate if different messaging impacts response rates to a brief survey (i.e., the simplified eligibility tool) that is designed to estimate pack-year eligibility for lung cancer screening (LCS). This will help to identify the best way to increase response rates to the tool in future intervention studies designed to increase LCS, and expand upon survey methodology in general.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. meet age eligibility (50-80 years old) for LCS based on 2021 USPSTF guidelines; and
  2. have completed at least one primary care visit at Penn Medicine in 2020-2025

Exclusion Criteria:

  1. have a documented history of lung cancer;
  2. have a documented history of completing LCS at Penn Medicine;
  3. are listed as not wanting to be contacted or solicited for research; or
  4. do not otherwise meet inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1 (Introductory Message A + Tobacco Use Message A + Incentive)
Participants will receive two framed messages (AA) plus an incentive
Behavioral: Framed Introductory Message A
Randomly assign patients to receive introductory message encouraging them to complete the survey (version A).
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Experimental: Arm 2 (Introductory Message A + Tobacco Use Message A)
Participants will receive two framed messages (AA)
Behavioral: Framed Introductory Message A
Randomly assign patients to receive introductory message encouraging them to complete the survey (version A).
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Experimental: Arm 3 (Introductory Message A + Tobacco Use Message B + Incentive)
Participants will receive two framed messages (AB) plus an incentive
Behavioral: Framed Introductory Message A
Randomly assign patients to receive introductory message encouraging them to complete the survey (version A).
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Experimental: Arm 4 (Introductory Message A + Tobacco Use Message B)
Participants will receive two framed messages (AB)
Behavioral: Framed Introductory Message A
Randomly assign patients to receive introductory message encouraging them to complete the survey (version A).
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Experimental: Arm 5 (Introductory Message B + Tobacco Use Message A + Incentive)
Participants will receive two framed messages (BA) plus an incentive
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Behavioral: Framed Introductory Message B
Randomly assign patients to receive introductory message encouraging them to complete the survey (version B).
Experimental: Arm 6 (Introductory Message B + Tobacco Use Message A)
Participants will receive two framed messages (BA)
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Behavioral: Framed Introductory Message B
Randomly assign patients to receive introductory message encouraging them to complete the survey (version B).
Experimental: Arm 7 (Introductory Message B + Tobacco Use Message B + Incentive)
Participants will receive two framed messages (BB) plus an incentive
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Behavioral: Framed Introductory Message B
Randomly assign patients to receive introductory message encouraging them to complete the survey (version B).
Experimental: Arm 8 (Introductory Message B + Tobacco Use Message B)
Participants will receive two framed messages (BB)
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Behavioral: Framed Introductory Message B
Randomly assign patients to receive introductory message encouraging them to complete the survey (version B).
Experimental: Arm 9 (Introductory Message C + Tobacco Use Message A + Incentive)
Participants will receive two framed messages (CA) plus an incentive
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Behavioral: Framed Introductory Message C
Randomly assign patients to receive introductory message encouraging them to complete the survey (version C).
Experimental: Arm 10 (Introductory Message C + Tobacco Use Message A)
Participants will receive two framed message (CA)
Behavioral: Framed Tobacco Use Message A
Randomly assign patients to receive norming message related to tobacco use (version A).
Behavioral: Framed Introductory Message C
Randomly assign patients to receive introductory message encouraging them to complete the survey (version C).
Experimental: Arm 11 (Introductory Message C + Tobacco Use Message B + Incentive)
Participants will receive two framed messages (CB) plus an incentive
Behavioral: Financial Incentive
Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Behavioral: Framed Introductory Message C
Randomly assign patients to receive introductory message encouraging them to complete the survey (version C).
Experimental: Arm 12 (Introductory Message C + Tobacco Use Message B)
Participants will receive two framed messages (CB)
Behavioral: Framed Tobacco Use Message B
Randomly assign patients to receive norming message related to tobacco use (version B).
Behavioral: Framed Introductory Message C
Randomly assign patients to receive introductory message encouraging them to complete the survey (version C).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Full Survey Completion
Time Frame: 7 days
The proportion of participants that answers all three survey questions via text message among all those randomized.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Partial Survey Completion
Time Frame: 7 days
The proportion of participants that answer at least one of three survey questions via text message among all those randomized.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center at Penn Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katharine A Rendle, PhD,MSW,MPH, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 16523
  • P50CA271338-02 (U.S. NIH Grant/Contract)
  • 853337 (Other Identifier: UPenn IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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