Back to resultsThe INSPIRE-Lung Study
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LungTalk
Non-tailored intervention - Standard of practice
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Lung cancer screening, Social media, Tailored interventions
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)
Sites / Locations
- Hackensack Meridian Health - Center for Discovery and InnovationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored health communication intervention (LungTalk)
Non-tailored Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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).
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".
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".
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05824273
First Posted
April 10, 2023
Last Updated
August 2, 2023
Sponsor
Hackensack Meridian Health
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05824273
Brief Title
The INSPIRE-Lung Study
Official Title
Leveraging Social Media to Increase Lung Cancer Screening Awareness, Knowledge and Uptake in High-Risk Populations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
July 30, 2027 (Anticipated)
Study Completion Date
July 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer screening, Social media, Tailored interventions
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tailored health communication intervention (LungTalk)
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-tailored Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LungTalk
Intervention Description
LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool.
Intervention Type
Behavioral
Intervention Name(s)
Non-tailored intervention - Standard of practice
Intervention Description
ACS Lung Screening Informational Video
Primary Outcome Measure Information:
Title
Reaching screening eligible individuals via social media - Reach
Description
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.
Time Frame
Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first)
Title
Reaching screening eligible individuals via social media - Link Clicks
Description
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.
Time Frame
Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first)
Title
Reaching screening eligible individuals via social media - Impressions
Description
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).
Time Frame
Within 4 years from the time the ad will appear on Facebook or until target enrollment is reached (whichever comes first)
Title
Effectiveness of LungTalk - Knowledge Assessment
Description
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".
Time Frame
At baseline
Title
Effectiveness of LungTalk - Knowledge Assessment
Description
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".
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Perceived Risk
Description
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).
Time Frame
At baseline
Title
Effectiveness of LungTalk - Perceived Risk
Description
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).
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Perceived Benefits
Description
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).
Time Frame
At baseline
Title
Effectiveness of LungTalk - Perceived Benefits
Description
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).
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Perceived Barriers
Description
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).
Time Frame
At baseline
Title
Effectiveness of LungTalk - Perceived Barriers
Description
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).
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Self-Efficacy
Description
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).
Time Frame
At baseline
Title
Effectiveness of LungTalk - Self-Efficacy
Description
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).
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
Description
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.
Time Frame
At baseline
Title
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
Description
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.
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
Description
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.
Time Frame
At 6 months from baseline survey completion
Title
Effectiveness of LungTalk - Screening Uptake
Description
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).
Time Frame
At baseline
Title
Effectiveness of LungTalk - Screening Uptake
Description
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).
Time Frame
At one week from baseline survey completion
Title
Effectiveness of LungTalk - Screening Uptake
Description
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).
Time Frame
At 6 months from baseline survey completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Valenzona
Phone
2018803400
Email
francis.valenzona@hmh-cdi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Carter-Bawa, PhD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health - Center for Discovery and Innovation
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
07110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Valenzona
Phone
201-880-3400
Email
francis.valenzona@hmh-cdi.org
12. IPD Sharing Statement
Plan to Share IPD
No
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