[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07615764":3,"trial-entities:NCT07615764":121,"trial-summary:NCT07615764":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":50,"secondary_outcomes":59,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":92,"locations":95,"central_contacts":114,"overall_officials":117,"references":119,"see_also_links":120},"NCT07615764","RG1126249","An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial","Lung Health Promotion for AI\u002FAN People Through Human Center Design (Lung PATHS) - Aim 3 Intervention","NOT_YET_RECRUITING","2027-05-31","2026-05","2026-05-29","2026-11-01","Fred Hutchinson Cancer Center","OTHER",false,"This clinical trial evaluates the acceptability and effectiveness of an educational intervention (Lung Toolkit) for improving knowledge about lung cancer and lung cancer screening among American Indian\u002FAlaskan Native (AI\u002FAN) cigarette smokers. The Lung Toolkit is an educational intervention, including a website and a physical artifact pouch, specifically tailored to the needs of AI\u002FAN individuals. The website includes evidence-based resources about lung health and lung cancer screening, facts about commercial tobacco and traditional tobacco, national and local smoking cessation and screening resources, and community-building resources such as stories from AI\u002FAN community members about their experiences with lung cancer screening and smoking cessation. The physical artifact pouch links to the website with a quick response code and contains ceremonial herbs and motivational messaging around smoking cessation and lung cancer screening. The Lung Toolkit intervention may be effective for improving knowledge about lung cancer and lung cancer screening among AI\u002FAN cigarette smokers.","OUTLINE:\n\nParticipants receive the Lung Toolkit materials, including a link to the lung health toolkit website and a physical artifact pouch, and then receive a guided review of the Lung Toolkit materials over 60 minutes. Following the guided review, participants use the Lung Toolkit materials for 30 days.",[19],"Lung Carcinoma",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29,39,43,47],{"type":14,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"Educational Intervention","Receive Lung Toolkit materials",[33],"Prevention (Lung Toolkit)",[35,36,37,38],"Education for Intervention","Intervention by Education","Intervention through Education","Intervention, Educational",{"type":14,"name":30,"description":40,"armGroupLabels":41,"otherNames":42},"Receive guided review of Lung Toolkit materials",[33],[35,36,37,38],{"type":14,"name":44,"description":45,"armGroupLabels":46},"Interview","Ancillary studies",[33],{"type":14,"name":48,"description":45,"armGroupLabels":49},"Questionnaire Administration",[33],[51,55],{"measure":52,"description":53,"timeFrame":54},"Acceptability of intervention","Acceptability will be evaluated using the Acceptability of Intervention (AIM) assessment score and semi-structured interviews. AIM results will be summarized and presented as a range of score from 1 to 5.","At post-guided review assessment (day 15) and post-intervention (day 45)",{"measure":56,"description":57,"timeFrame":58},"Lung cancer screening knowledge","Will be evaluated using a validated measure for assessing lung cancer screening knowledge (Lung Cancer Screening Knowledge Score \\[LKS\\]-7). Pre- and post-intervention LKS responses will be compared via Cochran-Mantel-Haenszel and Friedman tests.","From baseline to day 45",[60,64,67,70,73],{"measure":61,"description":62,"timeFrame":63},"User engagement","The effectiveness of the website in terms of engagement will be measured by tracking of bounce rate (percentage of visitors who land on website homepage and leave immediately without taking any further action, or viewing other pages).","During 30-day use period",{"measure":65,"description":66,"timeFrame":63},"User behavior","Participant behavior, and how participants navigate the website will be measured through click tracking (tracking of where users click on a website).",{"measure":68,"description":69,"timeFrame":58},"Medical mistrust","The intervention efficacy potential to mitigate medical mistrust will be evaluated using validated measures of discrimination and medical mistrust (Discrimination in Medical Settings; Group-Based Medical Mistrust Scale). Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.",{"measure":71,"description":72,"timeFrame":58},"Perceived smoking-related stigma","The intervention efficacy potential to reduce perceived smoking-related stigma will be evaluated using a validated measure of perceived smoking-related stigma (Cataldo Lung Cancer Stigma Scale, smoking-related subscale). Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.",{"measure":74,"description":75,"timeFrame":58},"Self-efficacy for lung cancer screening","The intervention efficacy potential to improve self-efficacy for lung cancer screening will be evaluated using a validated 9-item measure assessing self-efficacy for lung cancer screening. Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.","ALL","50 Years","80 Years",true,{"inclusion":81,"exclusion":86,"raw_text":91},[82,83,84,85],"Between ages 50-80","Self-identify as AI\u002FAN","Self-reported 10 pack-year smoking history (commercial tobacco i.e. cigarettes)","Ability to understand and willingness to sign an informed consent document",[87,88,89,90],"Not between ages 50-80","Having less than a 10 pack-year history of smoking commercial tobacco","Inability to communicate in written and verbal English","Having any cognitive impairment that compromises the ability to provide informed consent","Inclusion Criteria:\n\n* Between ages 50-80\n* Self-identify as AI\u002FAN\n* Self-reported 10 pack-year smoking history (commercial tobacco i.e. cigarettes)\n* Ability to understand and willingness to sign an informed consent document\n\nExclusion Criteria:\n\n* Not between ages 50-80\n* Having less than a 10 pack-year history of smoking commercial tobacco\n* Inability to communicate in written and verbal English\n* Having any cognitive impairment that compromises the ability to provide informed consent",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":111},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[103,108],{"name":104,"role":105,"phone":106,"email":107},"Nicolas Anderson","CONTACT","206-667-5434","nanders3@fredhutch.org",{"name":109,"role":110},"Matthew Triplette, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},47.60621,-122.33207,[115],{"name":104,"role":105,"phone":116,"email":107},"206.667.5434",[118],{"name":109,"affiliation":97,"role":110},[],[],{"nct_id":4,"conditions":122,"biomarkers":123},[19],[],{"nct_id":4,"found":79,"summary":125,"prompt_version":135},{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This interventional study plans to enroll 60 participants to test an educational intervention. It is not specified if it is randomized or blinded.","completed","Educational Program for Lung Cancer Knowledge in American Indian\u002FAlaskan Native Smokers","This study is testing an educational program called the \"Lung Toolkit\" to see if it helps American Indian and Alaskan Native (AI\u002FAN) cigarette smokers learn more about lung cancer and screening. The Lung Toolkit includes a website and physical materials designed specifically for AI\u002FAN individuals, offering resources on lung health, commercial and traditional tobacco, and community stories. The goal is to see how well people accept the Lung Toolkit and if it improves their knowledge about lung cancer screening. You may be able to join if you are an AI\u002FAN individual between 50 and 80 years old, and have smoked for at least 10 pack-years. The study is planning to enroll 60 participants, but its current status is unclear.","Your acceptability of the intervention will be measured at day 15 and day 45. Your lung cancer screening knowledge will be measured from the start of the study to day 45.",119,"Participants will receive Lung Toolkit materials, including a website link and a physical pouch. They will then have a 60-minute guided review, followed by 30 days of using the materials.","Not stated in the trial record.",[],"v2"]