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Trial Title: Lung Cancer Screening Eligibility Assessment

NCT ID: NCT06133816

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Lung Cancer Screening

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: We will use a randomized factorial design to test the effects of different types of messaging with or without incentives on response rates to an eligibility survey.

Primary purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Framed Introductory Message A
Description: Randomly assign patients to receive introductory message encouraging them to complete the survey (version A).
Arm group label: Arm 1 (Introductory Message A + Tobacco Use Message A + Incentive)
Arm group label: Arm 2 (Introductory Message A + Tobacco Use Message A)
Arm group label: Arm 3 (Introductory Message A + Tobacco Use Message B + Incentive)
Arm group label: Arm 4 (Introductory Message A + Tobacco Use Message B)

Intervention type: Behavioral
Intervention name: Framed Introductory Message B
Description: Randomly assign patients to receive introductory message encouraging them to complete the survey (version B).
Arm group label: Arm 5 (Introductory Message B + Tobacco Use Message A + Incentive)
Arm group label: Arm 6 (Introductory Message B + Tobacco Use Message A)
Arm group label: Arm 7 (Introductory Message B + Tobacco Use Message B + Incentive)
Arm group label: Arm 8 (Introductory Message B + Tobacco Use Message B)

Intervention type: Behavioral
Intervention name: Framed Introductory Message C
Description: Randomly assign patients to receive introductory message encouraging them to complete the survey (version C).
Arm group label: Arm 10 (Introductory Message C + Tobacco Use Message A)
Arm group label: Arm 11 (Introductory Message C + Tobacco Use Message B + Incentive)
Arm group label: Arm 12 (Introductory Message C + Tobacco Use Message B)
Arm group label: Arm 9 (Introductory Message C + Tobacco Use Message A + Incentive)

Intervention type: Behavioral
Intervention name: Framed Tobacco Use Message A
Description: Randomly assign patients to receive norming message related to tobacco use (version A).
Arm group label: Arm 1 (Introductory Message A + Tobacco Use Message A + Incentive)
Arm group label: Arm 10 (Introductory Message C + Tobacco Use Message A)
Arm group label: Arm 2 (Introductory Message A + Tobacco Use Message A)
Arm group label: Arm 5 (Introductory Message B + Tobacco Use Message A + Incentive)
Arm group label: Arm 6 (Introductory Message B + Tobacco Use Message A)
Arm group label: Arm 9 (Introductory Message C + Tobacco Use Message A + Incentive)

Intervention type: Behavioral
Intervention name: Framed Tobacco Use Message B
Description: Randomly assign patients to receive norming message related to tobacco use (version B).
Arm group label: Arm 11 (Introductory Message C + Tobacco Use Message B + Incentive)
Arm group label: Arm 12 (Introductory Message C + Tobacco Use Message B)
Arm group label: Arm 3 (Introductory Message A + Tobacco Use Message B + Incentive)
Arm group label: Arm 4 (Introductory Message A + Tobacco Use Message B)
Arm group label: Arm 7 (Introductory Message B + Tobacco Use Message B + Incentive)
Arm group label: Arm 8 (Introductory Message B + Tobacco Use Message B)

Intervention type: Behavioral
Intervention name: Financial Incentive
Description: Randomly assigned patients to be entered into a drawing to receive a $100 gift card.
Arm group label: Arm 1 (Introductory Message A + Tobacco Use Message A + Incentive)
Arm group label: Arm 11 (Introductory Message C + Tobacco Use Message B + Incentive)
Arm group label: Arm 3 (Introductory Message A + Tobacco Use Message B + Incentive)
Arm group label: Arm 5 (Introductory Message B + Tobacco Use Message A + Incentive)
Arm group label: Arm 7 (Introductory Message B + Tobacco Use Message B + Incentive)
Arm group label: Arm 9 (Introductory Message C + Tobacco Use Message A + Incentive)

Summary: 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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 50 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Pennsylvania

Address:
City: Philadelphia
Zip: 19104
Country: United States

Start date: July 31, 2023

Completion date: December 31, 2027

Lead sponsor:
Agency: Abramson Cancer Center at Penn Medicine
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Abramson Cancer Center at Penn Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06133816

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