A Phase 3 interventional study of Should I Screen website and Should I Screen print booklet in Population at Risk, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Georgetown University · Phase 3, Interventional, and Screening
The specific aims are:
Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability.
Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions
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This study's enrollment of 298 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Exclusion Criterion:
The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.
Behavioral: Should I Screen website
The Should I Screen print-based education (included with this IRB protocol) will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.
Behavioral: Should I Screen print booklet
The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.
The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.
Reach of eligible quitline users
% of eligible quitline users enrolled in the trial;
Time frame: baseline assessment
Intervention Engagement of eligible quitline users
WEB: electronic assessment of 1) logged on, 2) total time spent on website, 3) sections accessed; PRINT: self-reported time spent reading;
Time frame: one month assessment
Satisfaction with the intervention materials.
Assessment of satisfaction with length, format, and content of the materials
Time frame: one month assessment
Lung cancer screening knowledge
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Time frame: one month assessment
Lung cancer screening knowledge
Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening
Time frame: four month assessment
Percentage of participants who intend to undergo lung cancer screening
Intent to undergo lung cancer screening
Time frame: one month assessment
Percentage of participants who intend to undergo lung cancer screening
Intent to undergo lung cancer screening
Time frame: four month assessment
Percentage of participants with an appointment for a shared decision making visit
Shared decision making appt, lung screening referral, completed lung scan.
Time frame: one month assessment
Percentage of participants with an appointment for a shared decision making visit
Shared decision making appt, lung screening referral, completed lung scan.
Time frame: four month assessment
Plan to share: Yes — Interested researchers can email the corresponding author to request access to deidentified data. A data analyais plan and IRB approval will be required.
Supporting information: Study protocol, Sap, Icf, Analytic code
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