[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491071":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":57,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":24,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)","EXPERIMENTAL","This arm will enroll patient and caregiver participants receiving evidence-based therapy as part of the protocol.\n\nParticipants will complete:\n\n* 6-16 sessions of therapy 1x\u002Fweek. Sessions are virtual or in-person at the Massachusetts General Hospital Cancer Center.\n* Surveys and questionnaires pre- and post-treatment.\n\nAt the discretion of the therapist and the supervising therapist, the participant may receive up to 4 booster sessions after completion of the specific treatment protocol.",[13],"Behavioral: Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)",{"label":15,"type":10,"description":16,"interventionNames":17},"Training in Individualized Evidence-Based Therapy in Cancer (Therapists)","This arm will enroll therapist participants as part of the protocol. Therapists participants will enroll in the study and receive training in delivering evidence-based therapy to patients in the cancer center. Therapists will complete pre and post-measures of therapist self-efficacy and competence, as well as a semi-structured exit interview.",[18],"Behavioral: Training in Individualized Evidence-Based Therapy in Cancer (Therapists)",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.\n\n* Cognitive Behavioral Therapy (CBT)\n* Acceptance Commitment Therapy (ACT)\n* Mindfulness-Based Cognitive Therapy (MBCT)\n* Mindfulness-Based Stress Reduction (MBSR)\n* Meaning-Centered Psychotherapy (MCP)\n* Cognitive Behavioral Therapy for Insomnia (CBT-I)\n* CBT for pain\n* CBT for fatigue\n* CBT for nausea",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.",[15],[29],{"name":30,"affiliation":5,"role":31},"Jamie Jacobs, Ph.D","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","617-643-1777","jjacobs@mgh.harvard.edu",{"name":38,"role":34,"phone":35,"phoneExt":24,"email":39},"Amy Clara, PsyD","aclara@partners.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Massachusetts General Hospital Cancer Center","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},[56],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"type":31,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Jamie Jacobs","Principal Investigator","100491071","training-in-evidence-based-treatments-in-psycho-oncology-100491071",false,"NCT05674357","Training in Evidence-based Treatments in Psycho-Oncology","Patient Inclusion Criteria:\n\n* Adults \\> 18 years of age.\n* Currently receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance.\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3.\n* Reports distress or presenting problem is related to patients' illness and\u002For treatment (e.g., cancer treatment).\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.\n* Located in the state of Massachusetts for the duration of sessions.\n\nCaregiver Inclusion criteria:\n\n* Adults \\> 18 years of age\n* Currently caring for someone receiving oncology treatment\u002Fcare at the MGH Cancer Center, including active treatment and\u002For surveillance\n* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \\> 3\n* Reports distress or presenting problem is related to caregiving\n* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia\u002Fsleep disturbance) for caregiving-related distress per therapist and supervising therapist discretion\n* Located in the state of Massachusetts for the duration of sessions\n\nPatient Exclusion Criteria:\n\n* Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n* Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).\n* Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.\n* Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).\n\nTherapist Inclusion criteria:\n\n-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.\n\nTherapist Exclusion criteria:\n\n-Obtained licensure as a clinical psychologist in any state.","ALL","18 Years",{"count":69,"type":70},115,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress.\n\nThe intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.\n\n* Cognitive Behavioral Therapy (CBT)\n* Acceptance Commitment Therapy (ACT)\n* Mindfulness-Based Cognitive Therapy (MBCT)\n* Mindfulness-Based Stress Reduction (MBSR)\n* Meaning-Centered Psychotherapy (MCP)\n* Cognitive Behavioral Therapy for Insomnia (CBT-I)\n* CBT for other cancer-related physical symptoms like pain, fatigue, and nausea.\n\nParticipation in this research study is expected to last about 26 weeks.\n\nIt is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.",[76,77,78,79,80],"Distress, Emotional","Depression, Anxiety","Fatigue","Pain","Insomnia",[82,83,84,85,86,87],"CBT","Cognitive-Behavioral Therapies","Emotional Distress","Anxiety","Depression","Symptom-Related Distress","2026-06-11",{"date":90,"type":91},"2026-06-15","ACTUAL",{"date":93,"type":91},"2023-01-09",{"date":95,"type":70},"2029-01-01",{"name":5,"class":6},1]