The INSPIRE-Lung Study

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824273
• Other study ID #: Pro2022-0860
• Secondary ID: 7R01CA263662-02
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: July 30, 2027

Study information

• Verified date: January 2024
• Source: Hackensack Meridian Health
• Contact: Francis Valenzona
• Phone: 2018803400
• Email: francis.valenzona[@]hmh-cdi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• LungTalk
LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool.
• Non-tailored intervention - Standard of practice
ACS Lung Screening Informational Video

Locations

Country	Name	City	State
United States	Hackensack Meridian Health - Center for Discovery and Innovation	Nutley	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack Meridian Health	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (54)

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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