[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04761328":3,"trial-entities:NCT04761328":97,"trial-summary:NCT04761328":101},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":65,"locations":68,"central_contacts":84,"overall_officials":90,"references":95,"see_also_links":96},"NCT04761328","STUDY19110214","Fear of Recurrence and Stopping Immunotherapy","Distress Associated With Stopping Immunotherapy of Cancer Patients","RECRUITING","2028-12-31","2025-12","2025-12-05","2021-08-02","University of Pittsburgh","OTHER",false,"The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.","The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.",[19],"Cognitive Behavioral Therapy",[21,22,23,24],"Fear of recurrence","Quality of life","Depression","Anxiety","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},100,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","cognitive behavioral therapy","Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.",[38],"Cessation of treatment",[40],{"measure":41,"description":42,"timeFrame":43},"Reduce fear of recurrence","Change by 50%","3 months",[45,48,51],{"measure":46,"description":47,"timeFrame":43},"Improve quality of life","Change of quality of life by 5 points",{"measure":49,"description":50,"timeFrame":43},"Reduction of anxiety","Change of anxiety by 2 points",{"measure":52,"description":53,"timeFrame":43},"Depressive symptoms","Change by 25%","ALL","21 Years",null,{"inclusion":58,"exclusion":62,"raw_text":64},[59,60,61],"Age 21 years and older","Fluent in English","Diagnosis of cancer and history of treatment with immunotherapy",[63],"Active suicidal ideation, delusions or hallucinations","Inclusion Criteria:\n\n* Age 21 years and older\n* Fluent in English\n* Diagnosis of cancer and history of treatment with immunotherapy\n\nExclusion Criteria:\n\n* Active suicidal ideation, delusions or hallucinations",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"UPMC Hillman Cancer Centers","Pittsburgh","Pennsylvania","15213","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Jennifer L Steel, Ph.D.","CONTACT","412-692-2041","steejl@upmc.edu",{"lat":82,"lon":83},40.44062,-79.99589,[85,86],{"name":77,"role":78,"phone":79,"email":80},{"name":87,"role":78,"phone":88,"email":89},"Jason Luke, MD","412-623-4511","lukejj@upmc.edu",[91],{"name":92,"affiliation":93,"role":94},"Jason Luke","Hillman Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Malignant Neoplasm",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This interventional study plans to enroll 100 participants. It will test cognitive behavioral therapy delivered through telemedicine.","completed","Cognitive Behavioral Therapy for Fear of Recurrence After Immunotherapy","This study is looking at how cognitive behavioral therapy (a type of talk therapy that helps you change unhelpful thoughts and behaviors) can help people who are worried about their cancer coming back after they stop immunotherapy (a treatment that uses your body's own immune system to fight cancer). You can join if you are 21 or older, speak English fluently, have been diagnosed with cancer, and have received immunotherapy. The main goal is to see if this therapy can reduce your fear of recurrence (cancer coming back) within 3 months. The study is currently recruiting participants.","The primary endpoint is measured at 3 months, suggesting follow-up for at least this duration.",97,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]