[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07716527":3,"trial-entities:NCT07716527":111,"trial-summary:NCT07716527":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":14,"eligibility_criteria":84,"std_ages":94,"locations":97,"central_contacts":107,"overall_officials":108,"references":109,"see_also_links":110},"NCT07716527","Pro2026000388","Pilot Testing a Web-based Prototype of a Lung Cancer Screening Digital Health Tool","ENROLLING_BY_INVITATION","2026-10-15","2026-07","2026-07-21","2026-06-01","Rutgers, The State University of New Jersey","OTHER",false,"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.\n\nTo 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.\n\nThe 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.\n\nFor 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.\n\nParticipants 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.",[18],"Lung Cancer Screening",[20,21,22,23,24],"Lung cancer screening","Digital health tool","Web-based prototype","Prototype","Decision support","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},500,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Digital health tool prototype","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.",[38],"Intervention",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Control Arm - standard of care","The control arm will read a 2-page educational material about lung cancer screening publicly available from American Cancer Society.",[43],"Control",[45],{"measure":46,"description":47,"timeFrame":48},"Self- reported receipt of Lung Cancer Screening","Self-reported receipt of LCS within 3 months of exposure to the digital health tool","3 months",[50,54,57,60,63,66,69,72,75,78],{"measure":51,"description":52,"timeFrame":53},"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\u002Fagree\u002Fdisagree\u002Fstrongly disagree).","Immediately post-intervention (within 24 hours)",{"measure":55,"description":56,"timeFrame":53},"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.",{"measure":58,"description":59,"timeFrame":53},"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\u002Ftoo long\u002Fjust right), amount of information (too much\u002Ftoo little\u002Fjust right), balance (slanted towards LCS\u002Fnot slanted towards LCS\u002Fbalanced), usefulness of the website (yes\u002Fno), risk calculation understanding (easy\u002Fdifficult), and enough information (yes\u002Fno). The measure also includes two open-ended questions regarding what participants liked about the website and suggested improvements.",{"measure":61,"description":62,"timeFrame":53},"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.",{"measure":64,"description":65,"timeFrame":53},"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.",{"measure":67,"description":68,"timeFrame":53},"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.",{"measure":70,"description":71,"timeFrame":53},"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.",{"measure":73,"description":74,"timeFrame":53},"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.",{"measure":76,"description":77,"timeFrame":53},"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\u002FNo 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.",{"measure":79,"description":80,"timeFrame":53},"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.","ALL","50 Years","80 Years",{"inclusion":85,"exclusion":89,"raw_text":93},[86,87,88],"Age 50-80 years","Currently smoke or have quit smoking within the past 15 years","English-speaking",[90,91,92],"Younger than 50 years or older than 80 years","Never smoked or quit smoking more than 50 years ago","Non-English-speaking","Inclusion Criteria:\n\n* Age 50-80 years\n* Currently smoke or have quit smoking within the past 15 years\n* English-speaking\n\nExclusion Criteria:\n\n* Younger than 50 years or older than 80 years\n* Never smoked or quit smoking more than 50 years ago\n* Non-English-speaking",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901","United States",{"lat":105,"lon":106},40.48622,-74.45182,[],[],[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[18],[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to enroll 500 participants. It compares a digital health tool prototype to standard educational materials.","completed","Pilot Testing a Web-based Tool for Lung Cancer Screening","This study is testing a new web-based tool designed to help people make informed decisions about lung cancer screening. Researchers want to see if this \"digital health tool prototype\" is easy to use and helpful. You might be eligible if you are 50-80 years old, currently smoke or quit within the last 15 years, and speak English. Half of the participants will use the digital health tool, which includes information about screening, a personalized risk calculator, and patient stories. The other half will read a standard educational handout from the American Cancer Society. The main goal is to see if using the digital tool leads to more people getting lung cancer screening after three months.","Participants will be followed for three months to see if they received lung cancer screening.",115,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]