[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07165691":3,"trial-entities:NCT07165691":137,"trial-summary:NCT07165691":141},{"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":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":56,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":104,"locations":107,"central_contacts":125,"overall_officials":132,"references":135,"see_also_links":136},"NCT07165691","Pro2025001472","TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics","RECRUITING","2027-06-30","2025-11","2025-12-02","2025-09-11","Rutgers, The State University of New Jersey","OTHER",false,"Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer.\n\nAim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable.\n\nAim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.","This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.",[18],"Lung Neoplasms",[20,21,22,23,24,25,26,27,18],"lung cancer screening","shared decision making","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Lung Diseases","Respiratory Tract Diseases","INTERVENTIONAL","SCREENING",[31],"NA",{"count":33,"type":34},91,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","TELESCOPE, Remote Decision Coaching with Navigation Intervention","The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed",[41],"TELESCOPE intervention",[43,47,50,53],{"measure":44,"description":45,"timeFrame":46},"Recruitment rate","The investigators expect a recruitment rate of ≥60%.","1 week post-intervention",{"measure":48,"description":49,"timeFrame":46},"Participant Acceptability","The Ottawa Acceptability Measure will assess the acceptability of the TELESCOPE intervention from the patient's perspective at 1-week post-intervention. There is no total score for this measure. Responses will be reported descriptively in terms of proportions responding positively or negatively for each criteria.",{"measure":51,"description":52,"timeFrame":46},"Follow-up completion rate","The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments",{"measure":54,"description":55,"timeFrame":46},"Intervention Fidelity Rate","The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.",[57,61,64,68,71],{"measure":58,"description":59,"timeFrame":60},"Rate of participants that have completed LDCT","The investigators will assess the rates of completion of LDCT at 3 months post-intervention for all participants. This will be abstracted from patients' medical records.","3 months post-intervention",{"measure":62,"description":63,"timeFrame":46},"To assess shared decision making quality","This will be assessed with the Shared Decision-Making Process Survey (SDM Process\\_4), which is a 4-item performance measure of the process and outcome of shared decision making. Scores range from 0 to 4, with higher scores indicating a better process.",{"measure":65,"description":66,"timeFrame":67},"Feasibility of intervention (Clinicians)","The feasibility of the intervention (FIM) measure will be completed by clinicians. The total score for this instrument ranges from 4 to 20, with higher scores indicating greater feasibility.","12 months post-intervention",{"measure":69,"description":70,"timeFrame":67},"Clinicians Acceptability","The acceptability of the intervention (AIM) will be completed by clinicians. The total score ranges from 4 to 20, with higher scores indicating greater acceptability.",{"measure":72,"description":73,"timeFrame":74},"Intervention Appropriateness (Clinicians)","The Intervention Appropriateness Measure (IAM) will be completed by clinicians. The total score for each instrument ranges from 4 to 20, with higher scores indicating greater acceptability.","Post-intervention","ALL","50 Years","77 Years",true,{"inclusion":80,"exclusion":92,"raw_text":103},[81,82,83,84,85,86,87,88,89,90,91,89,90],"Identify as Hispanic or Latino(a)","Able to speak and read in English or Spanish","Be 50 to 77 years of age","Be a current or former smoker having quit within the past 15 years","Have at least a 20 pack-year smoking history","Be scheduled for a non-acute care visit at one of the study sites.","Not coughing up blood in the last two weeks","A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator","Age 18 or older","Fluent in English","A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator",[93,94,95,96,97,98,99,100,101,102],"Do not speak English","Are not Hispanic or Latino(a)","Have a history of lung cancer","Had a CT scan in the past 12 months","Has been coughing up blood in the last two weeks","Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider,","Are unable to provide informed consent Interviews","Are unable to provide informed consent Online surveys","Are unable to provide informed consent","Women who are pregnant.","Inclusion Criteria:\n\nAim 1 (Cultural Adaptation):\n\nTo be eligible, patients must:\n\n1. Identify as Hispanic and\u002For Latino(a)\n2. Able to read and speak in English or Spanish\n3. Be 50 to 77 years of age\n4. Be a current or former smoker\n5. Have at least a 20-pack-year smoking history\n\nAims 2-3 (Pilot Randomized Controlled Trial)\n\nTo be eligible, patients must:\n\n* Identify as Hispanic or Latino(a)\n* Able to speak and read in English or Spanish\n* Be 50 to 77 years of age\n* Be a current or former smoker having quit within the past 15 years\n* Have at least a 20 pack-year smoking history\n* Be scheduled for a non-acute care visit at one of the study sites.\n* Not coughing up blood in the last two weeks\n\nInterviews\n\nProviders completing the semi-structured interviews will be:\n\n* A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator\n* Age 18 or older\n* Fluent in English\n\nOnline surveys\n\nProviders completing online PRISM construct surveys will be:\n\n* A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator\n* Age 18 or older\n* Fluent in English\n\nExclusion Criteria:\n\nFor the cluster randomized trial, excluded will be patients who:\n\n* Do not speak English\n* Are not Hispanic or Latino(a)\n* Have a history of lung cancer\n* Had a CT scan in the past 12 months\n* Has been coughing up blood in the last two weeks\n* Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider,\n* Are unable to provide informed consent Interviews\n\nProviders\u002Fadministrators will be excluded if they:\n\n* Are unable to provide informed consent Online surveys\n* Are unable to provide informed consent\n* Women who are pregnant.",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":109,"status":7,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":122},"Rutgers Cancer Institute","New Brunswick","New Jersey","08901","United States",[115,120],{"name":116,"role":117,"phone":118,"email":119},"Evelyn Arana, DrPH","CONTACT","908-642-0861","earana@cinj.rutgers.edu",{"name":116,"role":121},"PRINCIPAL_INVESTIGATOR",{"lat":123,"lon":124},40.48622,-74.45182,[126,128],{"name":116,"role":117,"phone":127,"email":119},"9086420861",{"name":129,"role":117,"phone":130,"email":131},"Arlette Chavez-Iniguez, MD","(732)715-4923","ac2758@CINJ.Rutgers.edu",[133],{"name":116,"affiliation":134,"role":121},"Rutgers Cancer Institute of NJ",[],[],{"nct_id":4,"conditions":138,"biomarkers":140},[139],"Lung Carcinoma",[],{"nct_id":4,"found":78,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional pilot feasibility trial with about 91 participants. It aims to adapt an existing program for Hispanic individuals and then test its feasibility and acceptability.","completed","TELESCOPE Coaching for Lung Cancer Screening in Hispanic Individuals","This study, called TELESCOPE, is testing a coaching program designed to help Hispanic individuals decide about and get screened for lung cancer. The program includes a decision aid, coaching, referrals to smoking cessation services, and help navigating the screening process. We want to see if this program is easy to use and helpful for Hispanic people who smoke or used to smoke. To join, you must be Hispanic, between 50 and 77 years old, and have a history of smoking at least 20 pack-years. The study aims to recruit about 91 participants and will measure how many people join, how much they like the program, and how many complete their follow-up.","Participants will be followed for 1 week after the intervention to measure recruitment rate, acceptability, and follow-up completion rate.",111,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]