[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531420":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":74,"studyPopulation":66,"armGroups":75,"interventions":88,"overallOfficials":96,"centralContacts":100,"locations":106,"responsibleParty":125,"collaborators":127,"id":131,"slug":66,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":66,"enrollmentInfo":140,"targetDuration":66,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":109,"whyStopped":66,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Hackensack Meridian Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":66},[9,13,17,21,24,28,31,34,36,39],{"measure":10,"description":11,"timeFrame":12},"Feasibility - Retention (open trial)","Percentage of intervention arm participants who completed 2 out of 3 intervention sessions\u002Fcalls.","1-week post-scan",{"measure":14,"description":15,"timeFrame":16},"Feasibility - Retention (pilot RCT)","Percentage of intervention arm participants who completed 2 out of 3 coaching sessions\u002Fcalls.","3-month post-intervention",{"measure":18,"description":19,"timeFrame":20},"Feasibility - Web module engagement (open trial)","Percentage of intervention arm participants who completed at least 70% of the web modules.","1-week pre-scan and 1-week post-scan",{"measure":22,"description":19,"timeFrame":23},"Feasibility - Web module engagement (pilot RCT)","Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)",{"measure":25,"description":26,"timeFrame":27},"Acceptability of Intervention - Overall (open trial)","Percentage of intervention arm participants with mean ratings ≥4 on the validated Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. Acceptability will be assessed via participant ratings (mean scores ranging from 1 to 5, with higher scores indicating better acceptability).","1-week Pre-scan, 1-week post-scan, and 1-month follow-up",{"measure":29,"description":26,"timeFrame":30},"Acceptability of Intervention - Overall (pilot RCT)","post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)",{"measure":32,"description":33,"timeFrame":27},"Acceptability - Perceived helpfulness (open trial)","Percentage of intervention arm participants with ratings ≥4 on a 1-5 Likert item assessing perceived helpfulness of the intervention. Higher scores indicate greater perceived helpfulness.",{"measure":35,"description":33,"timeFrame":30},"Acceptability - Perceived helpfulness (Pilot RCT)",{"measure":37,"description":38,"timeFrame":27},"Acceptability - Usability (open trial)","Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.",{"measure":40,"description":38,"timeFrame":30},"Acceptability - Usability (Pilot RCT)",[42,45,49,52,55,58,60,64],{"measure":43,"description":44,"timeFrame":27},"Intervention engagement - Daily stress management skill practice (open trial)","Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.",{"measure":46,"description":47,"timeFrame":48},"Intervention engagement - Daily stress management skill practice (Pilot RCT)","Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys.","Repeated end-of-day surveys +\u002F- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization",{"measure":50,"description":51,"timeFrame":27},"Anxiety (open trial)","Anxiety will be measured via the validated PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 8a survey. T-scores range from 31.7 to 83.1, with higher scores indicating greater anxiety.",{"measure":53,"description":54,"timeFrame":48},"Anxiety (Pilot RCT)","Scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 4a survey using brief end-of-day surveys. T-scores range from 40.3 to 81.6 with higher scores indicating higher anxiety.",{"measure":56,"description":57,"timeFrame":27},"Cancer-related intrusive thoughts (open trial)","Cancer-related intrusive thoughts will be measured via validated the Impact of Events 6 item short form survey. Scores range from 0 to 24, with higher scores indicating higher levels of cancer-related intrusive thoughts.",{"measure":59,"description":57,"timeFrame":30},"Cancer-related intrusive thoughts (Pilot RCT)",{"measure":61,"description":62,"timeFrame":63},"Stress management skills (open trial)","Perceived stress management skill will be measured via the validated Measure of Current Status survey. Total scores range from 0 to 52 with higher scores indicating better stress management skills.","1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up",{"measure":65,"description":62,"timeFrame":30},"Stress management skills (Pilot RCT)",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":70,"primaryPurpose":71,"observationalModel":66,"timePerspective":66,"maskingInfo":72},"RANDOMIZED","PARALLEL","Open Trial phase: Unblinded, single-site, single-arm open trial (n=10). Pilot RCT phase: Unblinded, single-site, feasibility pilot randomized controlled trial (n=50; adapted stress management program vs. enhanced usual care).","SUPPORTIVE_CARE",{"masking":73,"maskingDescription":66,"whoMasked":66},"NONE","Cancer patients repeatedly undergo routine scans that inform their disease status and treatment. While awaiting the results, anxiety and uncertainty are elevated, which can negatively impact quality of life. Evidence-based stress management strategies have the potential to be useful during this unique time period, but require tailoring for this population and context.\n\nThe goal of this study is to pilot test an adapted stress management program to help patients manage their anxiety while awaiting scan results. The program is a behavioral intervention that includes psychoeducation and stress management activities, delivered via a web platform to promote dissemination. In the Open Trial phase, the program will be field tested in a single-arm trial, using feedback to refine materials and procedures as needed before formal piloting. In the Pilot RCT phase, a small RCT will be conducted to test the intervention's feasibility and acceptability and to examine preliminary effects on anxiety and other secondary outcomes.",[76,82],{"label":77,"type":78,"description":79,"interventionNames":80},"Adapted Stress Management Program","EXPERIMENTAL","The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist and program modules consisting of psychoeducation and stress management skill activities\u002Fpractice. They will also be provided with a list of mental health resources and crisis line information for use if needed.",[81],"Behavioral: Adapted Stress Management Program",{"label":83,"type":84,"description":85,"interventionNames":86},"Enhanced Usual Care","ACTIVE_COMPARATOR","Those randomized to enhanced usual care in the pilot RCT (n=25) will receive a resource list, tablet for study assessments, and reminder calls, but will not receive the program modules. They will also be provided with a list of mental health resources and crisis line information for use if needed.",[87],"Behavioral: Enhanced Usual Care",[89,93],{"type":90,"name":77,"description":91,"armGroupLabels":92,"otherNames":66},"BEHAVIORAL","Participants will receive a 15-minute orientation session in-person or remotely to introduce the program and to receive the study materials, including the instructional sheet, small booklet, and study tablet that will be used to promote practice of stress management exercises and for completing study assessments. They will complete self-guided web modules with stress management activities\u002Fskills on tablet devices, and will rate the modules' acceptability and perceived helpfulness. After visiting each module, they will be asked to practice at least one skill daily. In a second coaching session, they will be reminded about the skills, make a plan for using them, and troubleshoot questions about using the materials. Participants will attend scans and scan result appointments with their oncologist as usual. In a third coaching session, the stress management plan will be revisited for new concerns.",[77],{"type":90,"name":83,"description":94,"armGroupLabels":95,"otherNames":66},"Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.",[83],[97],{"name":98,"affiliation":5,"role":99},"Heather Derry-Vick, PhD","PRINCIPAL_INVESTIGATOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":66,"email":105},"Amanda Khoudary, BA","CONTACT","2018803445","Amanda.Khoudary@hmh-cdi.org",[107],{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Amanda Khoudary","RECRUITING","Hackensack","New Jersey","07601","United States","US",{"type":116,"coordinates":117},"Point",[118,119],-74.04347,40.88593,{"lat":119,"lon":118},[122,124],{"name":108,"role":103,"phone":123,"phoneExt":66,"email":105},"201-880-3445",{"name":98,"role":99,"phone":66,"phoneExt":66,"email":66},{"type":126,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR",[128],{"name":129,"class":130},"National Cancer Institute (NCI)","NIH","100531420",false,"NCT06199570","Support for Cancer Patients Awaiting News","Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program","SCAN","Inclusion Criteria:\n\n1. Adult (ages 18 and older)\n2. Comfortable speaking, reading, and writing English without an interpreter\n3. Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer)\n4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2\n5. Receiving ongoing care from collaborating clinics with regular scans\n6. Receiving systemic treatment for lung cancer\n7. Endorse appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study)\n8. Willingness to use the study website\n\nExclusion Criteria:\n\n1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)\n2. Requires an interpreter for medical visits\n3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)\n4. Currently enrolled in hospice\n5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)","ALL","18 Years",{"count":141,"type":142},60,"ESTIMATED","INTERVENTIONAL",[145],"NA","This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and\u002For protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).",[148],"Lung Cancer",[150,151,152,153,154],"Stress management","Cancer related anxiety","Scan related anxiety","Advanced lung cancer","lung cancer","2026-02-17",{"date":157,"type":158},"2026-02-19","ACTUAL",{"date":160,"type":158},"2024-05-01",{"date":162,"type":142},"2026-12-30",{"name":5,"class":6},1]