[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06305741":3,"trial-entities:NCT06305741":149,"trial-summary:NCT06305741":154},{"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":15,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":15,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":64,"locations":67,"central_contacts":136,"overall_officials":142,"references":145,"see_also_links":146},"NCT06305741","24-060","A Study of an Anxiety Intervention for Latino\u002FLatina\u002FHispanic Older Adults With Cancer and Their Caregivers","Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers","RECRUITING","2027-03","2026-03","2026-03-06","2024-03-05","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.",[18,19],"Cancer Patients","Care Givers",[21,22,5],"Anxiety Intervention","Latino caregivers","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Managing Anxiety from Cancer (MAC)","The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy intervention delivered via videoconference and\u002For telephone by licensed social workers OR at least a Master's level (or enrolled in a doctorate program) advanced trainees in mental health fields.",[35],"Latino caregivers and the Latino older adults with cancer (OACs)",[37],{"measure":38,"timeFrame":39},"percentage of participants to complete all study procedures","1 year",[],"ALL","40 Years",true,{"inclusion":45,"exclusion":53,"raw_text":63},[46,47,48,49,50,51,52,50],"As per medical record or self-report, is currently age 65 years or older","As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.","As per self-report, identifies as Latino and\u002For Hispanic Ethnicity","Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)","Per self-report, fluent in English and\u002For Spanish\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:","Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and\u002For practical support) for the eligible OAC patient","As per self-report, is age 40 years or older",[54,55,56,57,58,59,60,61,62,57,58],"As per medical record or self-report, currently receiving psychotherapy","As per medical record or self-report, taking psychotropic medications for \\\u003C 8 weeks prior to MAC Session 1 and\u002For anticipates changing their medication during the study","As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and\u002For bi-polar disorder","Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11","Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures","Per medical record or self-report, receiving hospice care at the time of enrollment","As per self-report, currently receiving psychotherapy","As per self-report, taking psychotropic medications for \\\u003C 8 weeks prior to MAC Session 1 and\u002For anticipates changing their medication during the study","As per self-report, currently being treated for schizophrenia, substance use or dependence, and\u002For bi-polar disorder","Inclusion Criteria:\n\nOlder Adults with Cancer (OAC)\n\n* As per medical record or self-report, is currently age 65 years or older\n* As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.\n* As per self-report, identifies as Latino and\u002For Hispanic Ethnicity\n* Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and\u002For practical support) age 40 or older who is willing and able to participate in the study ; if a patient does not have a primary informal caregiver or if the caregiver does not or cannot participate, but meets all other inclusion criteria they will be allowed to enroll in the study\n* Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)\n* Per self-report, fluent in English and\u002For Spanish\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:\n\n  1. How well do you speak English and\u002For Spanish? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English and\u002For Spanish)\n\nCaregiver\n\n* Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and\u002For practical support) for the eligible OAC patient\n* As per self-report, is age 40 years or older\n* Per self-report, fluent in English and\u002For Spanish\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:\n\n  1. How well do you speak English and\u002For Spanish? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English and\u002For Spanish)\n\nExclusion Criteria:\n\nOAC\n\n* As per medical record or self-report, currently receiving psychotherapy\n* As per medical record or self-report, taking psychotropic medications for \\\u003C 8 weeks prior to MAC Session 1 and\u002For anticipates changing their medication during the study\n* As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and\u002For bi-polar disorder\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record or self-report, receiving hospice care at the time of enrollment\n\nCaregiver\n\n* As per self-report, currently receiving psychotherapy\n* As per self-report, taking psychotropic medications for \\\u003C 8 weeks prior to MAC Session 1 and\u002For anticipates changing their medication during the study\n* As per self-report, currently being treated for schizophrenia, substance use or dependence, and\u002For bi-polar disorder\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures",[65,66],"ADULT","OLDER_ADULT",[68,82,91,100,110,119,127],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":79},"Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[75],{"name":76,"role":77,"phone":78},"Kelly McConnell, PhD","CONTACT","646-888-0026",{"lat":80,"lon":81},40.70621,-74.54932,{"facility":83,"status":8,"city":84,"state":71,"zip":85,"country":73,"contacts":86,"geoPoint":88},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",[87],{"name":76,"role":77,"phone":78},{"lat":89,"lon":90},40.39428,-74.11709,{"facility":92,"status":8,"city":93,"state":71,"zip":94,"country":73,"contacts":95,"geoPoint":97},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",[96],{"name":76,"role":77,"phone":78},{"lat":98,"lon":99},41.04676,-74.02292,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":73,"contacts":105,"geoPoint":107},"Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)","Commack","New York","11725",[106],{"name":76,"role":77,"phone":78},{"lat":108,"lon":109},40.84288,-73.29289,{"facility":111,"status":8,"city":112,"state":103,"zip":113,"country":73,"contacts":114,"geoPoint":116},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",[115],{"name":76,"role":77,"phone":78},{"lat":117,"lon":118},40.96899,-73.71263,{"facility":120,"status":8,"city":103,"state":103,"zip":121,"country":73,"contacts":122,"geoPoint":124},"Memorial Sloan Kettering Cancer Center (All protocol activities)","10065",[123],{"name":76,"role":77,"phone":78},{"lat":125,"lon":126},40.71427,-74.00597,{"facility":128,"status":8,"city":129,"state":103,"zip":130,"country":73,"contacts":131,"geoPoint":133},"Memorial Sloan Kettering Nassau (All Protocol Activities)","Rockville Centre","11553",[132],{"name":76,"role":77,"phone":78},{"lat":134,"lon":135},40.65871,-73.64124,[137,139],{"name":76,"role":77,"phone":78,"email":138},"mcconnek@mskcc.org",{"name":140,"role":77,"phone":141},"Christian Nelson, PhD","646-888-0030",[143],{"name":76,"affiliation":13,"role":144},"PRINCIPAL_INVESTIGATOR",[],[147],{"label":13,"url":148},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":150,"biomarkers":153},[151,152],"Caregivers","Malignant Neoplasm",[],{"nct_id":4,"found":43,"summary":155,"prompt_version":165},{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.","completed","Anxiety Intervention for Latino Older Adults with Cancer and Their Caregivers","This study is looking at a program called Managing Anxiety from Cancer (MAC) to see if it helps Latino older adults with cancer and their caregivers manage anxiety. MAC is a psychotherapy (talk therapy) program with seven sessions, each lasting 45-60 minutes. These sessions are given by video or phone by trained mental health professionals. The study wants to see how many people complete all parts of the study. You might be able to join if you are a Latino older adult with cancer, aged 65 or older, and are currently getting cancer treatment or finished treatment within the last 18 months. Caregivers of these individuals can also participate. The study is currently unclear about its recruitment status and plans to enroll 60 participants.","The study will measure how many participants complete all study procedures at 1 year.",124,"Participants will take part in seven psychotherapy sessions, each lasting 45-60 minutes, delivered via videoconference or telephone.","Not stated in the trial record.",[32],"v2"]