[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07173205":3,"trial-entities:NCT07173205":135,"trial-summary:NCT07173205":139},{"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":24,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":61,"secondary_outcomes":66,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":86,"locations":89,"central_contacts":126,"overall_officials":131,"references":133,"see_also_links":134},"NCT07173205","24-001496","Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit","R00 Full Factorial Trial: Optimizing ASCENT","RECRUITING","2027-03","2026-01","2026-01-07","2025-10-25","East Carolina University","OTHER",true,"Our team has developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes one psychoeducation component and four components that are based on evidence-based interventions for depression. The goal of this study is to test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs.",null,[19,20,21,22,23],"Depression","Cancer","Adolescent","Young Adult","Adult",[25,26,27,28,29,30,31],"AYA","Adolescent and Young Adult","Cancer Survivorship","Depressive Symptoms","Digital Mental Health","Multiphase Optimization Strategy","Full Factorial Trial","INTERVENTIONAL","SUPPORTIVE_CARE",[35],"NA",{"count":37,"type":38},208,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"BEHAVIORAL","AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)","Participants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill.",[45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60],"Condition 1","Condition 10","Condition 11","Condition 12","Condition 13","Condition 14","Condition 15","Condition 16","Condition 2","Condition 3","Condition 4","Condition 5","Condition 6","Condition 7","Condition 8","Condition 9",[62],{"measure":63,"description":64,"timeFrame":65},"Change in Depressive Symptoms during Intervention Period","The primary outcome for this study is change in depressive symptoms from Baseline to Week 6. In order to be considered for inclusion in the optimized intervention, intervention components must result in a 3-point decrease in T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS)® Computer Adaptive Test (CAT) for depression between W0 and W6. T-scores have a range from 0 to 100, a mean of 50, and a standard deviation of 10. On this measure, higher scores indicate greater depressive symptoms (worse outcome).","Baseline to Week 6",[67],{"measure":68,"description":69,"timeFrame":70},"Change in Depressive Symptoms at follow-up","The investigators will also evaluate change in depressive symptoms from Week 0 to Week 12 and Week 24 using the Patient-Reported Outcomes Measurement Information System (PROMIS)® Computer Adaptive Test (CAT) for depression. T-scores have a range from 0 to 100, a mean of 50, and a standard deviation of 10. On this measure, higher scores indicate greater depressive symptoms (worse outcome).","Baseline to Week 12","ALL","15 Years","39 Years",false,{"inclusion":76,"exclusion":82,"raw_text":85},[77,78,79,80,81],"Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)","Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)","Time since completion of treatment: 1 month to 5 years","Language: Fluent in English (spoken and written)","Technology: Own smart phone with data plan",[83,84],"Mental Health: Current diagnosis of severe or persistent mental illness","Suicidality: Severe suicidal ideation (including plan and intent)","Inclusion Criteria:\n\n* Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)\n* Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)\n* Time since completion of treatment: 1 month to 5 years\n* Language: Fluent in English (spoken and written)\n* Technology: Own smart phone with data plan\n\nExclusion Criteria:\n\n* Mental Health: Current diagnosis of severe or persistent mental illness\n* Suicidality: Severe suicidal ideation (including plan and intent)",[87,88],"CHILD","ADULT",[90,111],{"facility":13,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":108},"Greenville","North Carolina","27858","United States",[96,101,105],{"name":97,"role":98,"phone":99,"email":100},"AnneMarie Coffey, BS","CONTACT","252-328-6244","coffeya23@ecu.edu",{"name":102,"role":98,"phone":103,"email":104},"Karly M Murphy, PhD","252-737-4638","murphykar22@ecu.edu",{"name":106,"role":107},"Karly Murphy, PhD","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},35.61266,-77.36635,{"facility":112,"status":8,"city":113,"state":92,"zip":114,"country":94,"contacts":115,"geoPoint":123},"Wake Forest University","Winston-Salem","27109",[116,120],{"name":117,"role":98,"phone":118,"email":119},"Stephanie Bunch, MPH","336-716-5180","Stephanie.C.Bunch@advocatehealth.org",{"name":121,"role":98,"email":122},"John Salsman, PhD","jsalsman@wakehealth.edu",{"lat":124,"lon":125},36.09986,-80.24422,[127,128],{"name":97,"role":98,"phone":99,"email":100},{"name":129,"role":98,"email":130},"Lane Williamson","williamsonla24@students.ecu.edu",[132],{"name":102,"affiliation":13,"role":107},[],[],{"nct_id":4,"conditions":136,"biomarkers":138},[19,137],"Malignant Neoplasm",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":150},{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study with a planned enrollment of 208 participants. It is not specified if it is randomized or blinded.","completed","Digital Toolkit for Depression in Young Adult Cancer Survivors","This study is testing a digital tool called the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) to help adolescent and young adult (AYA) cancer survivors manage symptoms of depression after treatment. The ASCENT tool includes daily mood tracking and information about cancer and depression. Researchers want to see which parts of this tool are most helpful in improving depressive symptoms. You might be able to join if you are between 15 and 39 years old, were diagnosed with cancer between ages 12 and 39, and finished your treatment within the last 5 years. The study aims to enroll 208 participants, but its current recruitment status is unclear.","Depressive symptoms are measured during the intervention period, from baseline to Week 6.",108,"Participants will receive access to the digital ASCENT tool. The primary endpoint measures changes in depressive symptoms from baseline to Week 6.","Not stated in the trial record.",[42],"v2"]