The purpose of this study is to evaluate the acceptability, usability, and preliminary efficacy of a web-based prototype of a digital health tool for lung cancer screening (LCS). The digital health tool is designed to support high quality decision-making for individuals potentially eligible for lung cancer screening. Researchers will compare the intervention arm (who will use the digital health tool prototype) with the control arm (who will read a 2-page publicly available information sheet about lung cancer screening from American Cancer Society).
Lung cancer is the leading cause of cancer death in the US. In 2011, the landmark National Lung Screening Trial demonstrated that LCS using low-dose computed tomography (LDCT) can reduce lung cancer mortality by 20%, compared to chest X-rays, after annual screenings. Hence, the United States Preventive Services Task Force (USPSTF) recommends LCS for individuals age 50-80, who currently smoke or quit smoking within the past 15 years, and who have at least a 20 pack-year smoking history. The USPSTF gave LCS a Grade B recommendation, indicating that there is high certainty that the benefits of LCS outweigh the risks for this population. Despite the well-documented benefits of LCS and USPSTF's Grade B recommendation, LCS uptake remains very low at only 18%. In contrast, breast and colon cancer screening rates exceed 70%, even though their combined annual deaths are ¾ that of lung cancer. As LCS has both potential benefits and harms (e.g., false positives, small amounts of radiation exposure, potential invasive diagnostic testing), USPSTF also recommends that all patients undergo shared decision-making (SDM) prior to initial screening. Furthermore, the Centers for Medicare \& Medicaid Services (CMS) mandates an SDM conversation using a decision aid prior to initial screening. Yet, SDM is not routinely performed and patients are rarely informed about potential harms in routine practice. Hence, interventions aiming to improve LCS uptake and decision quality among high-risk populations are urgently needed to realize the mortality benefit of LCS. To address these gaps, the investigators will develop a digital health tool, which is an interactive website that delivers high-quality, standardized SDM and psychoeducation about LCS to patients. This study's aims are to: 1) evaluate acceptability of the digital health tool prototype among people with a smoking history; 2) assess changes in cognitive outcomes before and after exposure to the digital health tool and across comparison groups; and 3) assess the digital health tool's impact on LCS intentions. The digital health tool includes a home page and 7 modules: 1) a video decision aid about LCS; 2) video of the LDCT procedure; 3) lung cancer risk calculator and individualized lung cancer risk scores for patients; 4) patient testimonials; 5) frequently asked questions (e.g., costs associated with LDCT); 6) patient's decision; and 7) resources for smoking cessation. For this pilot study, the investigators will be utilizing a quantitative approach using surveys. This study will use a randomized pre-post design to assess the impact of exposure to the digital health tool prototype. Participants (N=500) will be randomized to view either the digital health tool prototype or standard education materials about LCS in a 1:1 ratio. Participants will be contacted 3 months after the initial survey to complete a brief follow-up survey assessing LCS behavior. Participants will be recruited through Qualtrics Research Panels. Potential participants will complete a screening form to confirm their eligibility. The inclusion criteria are: 1) age 50-80; and 2) currently smoke or quit smoking within the past 15 years. If they are eligible, potential participants will be directed to an informed consent form where they will be asked to indicate their agreement to participate in this study. Participants who agree to participate will then complete a pre-survey, use either the digital health tool prototype or standard education materials, and then complete a post-survey. 3 months after the initial survey, participants will be contacted again to complete a follow-up survey.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
500
Intervention participants will view a web-based interactive prototype of the digital health tool. The digital health tool contains information about lung cancer screening, the screening procedures, a personalized lung cancer risk calculator, patient stories, frequently asked questions, and smoking cessation resources.
The control arm will read a 2-page educational material about lung cancer screening publicly available from American Cancer Society.
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Self- reported receipt of Lung Cancer Screening
Self-reported receipt of LCS within 3 months of exposure to the digital health tool
Time frame: 3 months
Lung Cancer Screening Intention
Intention to undergo LCS in the next 3 months, measured during the post-test survey administered immediately after viewing the digital health tool. Patient will respond on a 4-point agreement scale (strongly agree/agree/disagree/strongly disagree).
Time frame: Immediately post-intervention (within 24 hours)
Stage of Decision Making
Stage of decision making will be assessed using the validated single-item Stage of Decision Making Scale. The measure assesses participants' readiness to make a decision regarding lung cancer screening by asking them to select one of six statements describing their current stage of decision making, ranging from not yet thinking about the decision to having made a decision and being unlikely to change their mind. Responses are coded on a 6-point ordinal scale, with higher scores indicating greater readiness or progression toward making a decision.
Time frame: Immediately post-intervention (within 24 hours)
Ottowa Acceptability Measure
Acceptability will be assessed using the 10-item validated Ottawa Acceptability of Decision Aid Measure. The Ottawa Acceptability Measure has 8 items evaluating each section of the digital health tool (4-point Likert scale ranging from Poor to Excellent), length of presentation (too short/too long/just right), amount of information (too much/too little/just right), balance (slanted towards LCS/not slanted towards LCS/balanced), usefulness of the website (yes/no), risk calculation understanding (easy/difficult), and enough information (yes/no). The measure also includes two open-ended questions regarding what participants liked about the website and suggested improvements.
Time frame: Immediately post-intervention (within 24 hours)
System Usability Scale (SUS)
Website usability will be assessed using the 10-item validated System Usability Scale (SUS). The SUS evaluates participants' overall perceptions of the usability of the digital health tool, including ease of use, complexity, consistency, confidence while using the system, and willingness to use the system frequently. Each item is rated on a 5-point Likert scale ranging from Strongly disagree to Strongly agree. After reverse scoring negatively worded items, responses are summed and converted to a 0-100 scale, with higher scores indicating better perceived usability.
Time frame: Immediately post-intervention (within 24 hours)
Knowledge of LCS
Knowledge of lung cancer screening will be assessed using the 20-item Lung Cancer Screening Knowledge Measure (LCS-15). The LCS-15 evaluates participants' knowledge of lung cancer screening, including eligibility criteria, screening frequency, potential benefits and harms of low-dose computed tomography (LDCT), false-positive results, overdiagnosis, incidental findings, radiation exposure, follow-up testing, and the importance of smoking cessation. Each item is answered using correct, incorrect, or "I don't know" response options. Correct responses are scored as 1, while incorrect and "I don't know" responses are scored as 0. Item scores are summed and converted to a 0-100% score, with higher scores indicating greater knowledge of lung cancer screening.
Time frame: Immediately post-intervention (within 24 hours)
Perceived risk
Perceived risk of lung cancer will be assessed using the 3-item Perceived Risk subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale measures participants' perceived susceptibility to developing lung cancer by assessing their perceived risk, likelihood of developing lung cancer in the next few years, and overall likelihood of developing lung cancer. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 3 to 12, with higher scores indicating greater perceived risk of developing lung cancer.
Time frame: Immediately post-intervention (within 24 hours)
Perceived benefits
Perceived benefits of lung cancer screening will be assessed using the 6-item Perceived Benefits subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale evaluates participants' beliefs about the benefits of undergoing lung cancer screening with low-dose computed tomography (LDCT), including beliefs that screening can detect lung cancer early, improve treatment outcomes, and reduce the risk of dying from lung cancer. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 6 to 24, with higher scores indicating stronger perceived benefits of lung cancer screening.
Time frame: Immediately post-intervention (within 24 hours)
Perceived barriers
Perceived barriers to lung cancer screening will be assessed using the 17-item Perceived Barriers subscale of the validated Lung Cancer Screening Health Belief Scales (LCSHBS). The subscale assesses participants' perceived emotional, practical, and logistical barriers to completing lung cancer screening, including concerns about cost, fear, time, transportation, inconvenience, and access. Items are rated on a 4-point Likert scale ranging from Strongly disagree to Strongly agree. Responses are summed to produce a total score ranging from 17 to 68, with higher scores indicating greater perceived barriers to lung cancer screening.
Time frame: Immediately post-intervention (within 24 hours)
Decisional Conflict (SURE)
Decisional conflict will be assessed using the 4-item validated SURE Test. The SURE Test evaluates whether participants feel certain about the best choice, understand the benefits and risks of available options, are clear about which benefits and risks matter most to them, and have sufficient support and advice to make a decision. Items are answered using Yes/No response options. Responses are summed to produce a total score ranging from 0 to 4, with higher scores indicating less decisional conflict and greater confidence in decision making.
Time frame: Immediately post-intervention (within 24 hours)
Preparation for Decision Making
Preparation for decision making will be assessed using the 10-item validated Preparation for Decision Making Scale (PrepDM). The PrepDM measures the extent to which the digital health tool prepares participants to communicate with their healthcare provider and make an informed decision about lung cancer screening. Items assess whether the tool helped participants recognize that a decision needs to be made, understand the benefits and harms of screening, clarify what matters most to them, organize their thoughts, identify questions for their healthcare provider, and prepare to discuss their preferences and make a decision. Each item is rated on a 5-point Likert scale ranging from Not at all to A great deal. Item scores are averaged and transformed to a 0-100 scale, with higher scores indicating greater perceived preparation for decision making.
Time frame: Immediately post-intervention (within 24 hours)
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