[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06172907":3,"trial-entities:NCT06172907":125,"trial-summary:NCT06172907":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":42,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":62,"locations":64,"central_contacts":110,"overall_officials":119,"references":123,"see_also_links":124},"NCT06172907","23-472","A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers","RECRUITING","2026-12","2025-12","2026-01-12","2024-04-19","Massachusetts General Hospital","OTHER",true,"The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.","Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.",[18,19,20,21,22,23],"Cancer","Survivorship","Caregiver Burden","Psychological Distress","Coping Skills","Couples",[25,26],"Young Adult Cancer","Cancer Caregiving","INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},20,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BEHAVIORAL","Young Adults Coping with Cancer Together Intervention","This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice.",[37],[41],"YAD Intervention",[43,47],{"measure":44,"description":45,"timeFrame":46},"Feasibility of Intervention","Feasibility will be measured by measured by participant rates of enrollment (≥50% of those eligible), participant retention (≥70% of those enrolled), and intervention attendance (≥70% attending at least 6 of 8 sessions).","14 +\u002F- 2 Weeks",{"measure":48,"description":49,"timeFrame":46},"Acceptability of Intervention","Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint.",[],"ALL","25 Years","39 Years",false,{"inclusion":56,"exclusion":60,"raw_text":61},[57,58,59],"Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)","Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions","English-speaking",[],"Inclusion Criteria:\n\n* Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)\n* Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions\n* English-speaking\n\nExclusion Criteria:\n\n• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment",[63],"ADULT",[65,80,90,100],{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"Massachusetts General Hospital Cancer Center","Boston","Massachusetts","02114","United States",[72,75],{"name":73,"role":74},"Jamie M Jacobs, PhD","CONTACT",{"name":73,"role":76},"PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},42.35843,-71.05977,{"facility":81,"status":7,"city":82,"state":68,"zip":83,"country":70,"contacts":84,"geoPoint":87},"Emerson Hospital\u002FMGH Cancer Center","Concord","01742",[85,86],{"name":73,"role":74},{"name":73,"role":76},{"lat":88,"lon":89},42.46037,-71.34895,{"facility":91,"status":7,"city":92,"state":68,"zip":93,"country":70,"contacts":94,"geoPoint":97},"Mass General at North Shore Cancer Center","Danvers","01923",[95,96],{"name":73,"role":74},{"name":73,"role":76},{"lat":98,"lon":99},42.57509,-70.93005,{"facility":101,"status":7,"city":102,"state":68,"zip":103,"country":70,"contacts":104,"geoPoint":107},"Mass General at Newton Wellesley Hospital","Newton","02462",[105,106],{"name":73,"role":74},{"name":73,"role":76},{"lat":108,"lon":109},42.33704,-71.20922,[111,115],{"name":112,"role":74,"phone":113,"email":114},"Jamie M Jacobs, Ph.D.","617-643-1777","jjacobs@mgh.harvard.edu",{"name":116,"role":74,"phone":117,"email":118},"Zeba N Ahmad, Ph.D.","617-724-1586","zahmad2@mgh.harvard.edu",[120,121],{"name":112,"affiliation":12,"role":76},{"name":122,"affiliation":12,"role":76},"Giselle K Perez, Ph.D.",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Malignant Neoplasm",[],{"nct_id":4,"found":14,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is a single-arm pilot study involving 20 participants (10 young adults with cancer and 10 partners).","completed","Intervention for Young Adults with Cancer and Their Partners","This study is testing a behavioral intervention called \"Young Adults Coping with Cancer Together Intervention\" for young adults (ages 25-39) with cancer and their partners who provide care. This intervention combines cognitive-behavioral therapy and couples' therapy to help improve coping skills, self-confidence in managing cancer and caregiving, and maintain relationships. The study aims to see if this intervention is practical and acceptable to participants. You may be able to join if you are a young adult with cancer receiving or recently finished treatment at Massachusetts General Cancer Center, or if you are the partner of such an individual. This study plans to enroll 20 participants.","Feasibility and acceptability of the intervention will be measured around 14 weeks after the start of the study.",105,"You would participate in an eight-session intervention. You will also complete surveys at the beginning and end of the intervention, and may be invited for an optional interview.","Not stated in the trial record.",[37],"v2"]