The INSPIRE-Lung Study

Study Overview
=================
Brief Summary
-----------------
LungTalk and leveraging Facebook-targeted Advertisement (FBTA) addresses the call to develop and test multi-level, cancer communication interventions using innovative methods and designs. The study's long term goal is to increase lung cancer screening uptake among appropriate, high-risk individuals nationwide.

Official Title
-----------------
Leveraging Social Media to Increase Lung Cancer Screening Awareness, Knowledge and Uptake in High-Risk Populations

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: LungTalk
* Behavioral: Non-tailored intervention - Standard of practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥20-pack-year smoking history; Individuals who currently smoke or quit smoking within the past 15 years Exclusion Criteria: Previously undergone LDCT for early detection of lung cancer, have a lung nodule or nodules that are currently being followed Has ever been diagnosed with lung cancer Individuals with impaired decision-making (because our primary outcome is decision-making, we will not include individuals with impaired decision-making)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored health communication intervention (LungTalk)<br>Participants will receive the tailored health intervention LungTalk. LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool that is theoretically grounded in the Conceptual Model on Lung Cancer Screening Participation. | Behavioral: LungTalk<br>* LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool.<br>|
| Active Comparator: Non-tailored Intervention<br>Participants will receive non-tailored American Cancer Society (ACS) Lung Screening Informational Video as per standard of care. ACS Lung Screening Informational Video (ACS LSIV) is a non-tailored 5-minute video from the American Cancer Society about lung cancer screening designed for the lay individual. | Behavioral: Non-tailored intervention - Standard of practice<br>* ACS Lung Screening Informational Video<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaching screening eligible individuals via social media - Reach | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of people who saw the FBTA at least once. | Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first) | 
| Reaching screening eligible individuals via social media - Link Clicks | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of clicks on the link within the FBTA that led to the REDCap survey platform of the study. | Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first) | 
| Reaching screening eligible individuals via social media - Impressions | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of times the FBTA was on screen (may include multiple views of the ad by the same person/people). | Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first) | 
| Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being No Knowledge and 9 being Complete knowledge. | At baseline | 
| Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being No Knowledge and 9 being Complete knowledge. | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | At baseline | 
| Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits). | At baseline | 
| Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits). | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers). | At baseline | 
| Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers). | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | At baseline | 
| Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At baseline | 
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At 6 months from baseline survey completion | 
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At baseline | 
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At one week from baseline survey completion | 
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At 6 months from baseline survey completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer screening, Social media, Tailored interventions