[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07729384":3,"trial-entities:NCT07729384":116,"trial-summary:NCT07729384":119},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":70,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":89,"locations":91,"central_contacts":109,"overall_officials":112,"references":114,"see_also_links":115},"NCT07729384","25-014110","A Study of Strengthening Teen Brain Resilience Using Music During Cancer Treatment","Strengthening Teen Brain Resilience Using Music (STRUM) During Cancer Treatment: A Pilot Feasibility Trial","NOT_YET_RECRUITING","2028-11-01","2026-07","2026-07-27","2026-10-01","Mayo Clinic","OTHER",null,"This clinical trial tests the feasibility and acceptability of the Strengthening Teen Brain Resilience Using Music (STRUM) intervention to improve radiation induced cognitive decline for adolescents undergoing radiation therapy for cancer treatment. Adolescents treated with radiation therapy for cancer often experience persistent cognitive deficits and reduced brain resilience or the ability to preserve cognitive and emotional functioning despite stressors. Musical instrument training has been shown to enhance memory, academic skills, and emotional well-being in youth. Although guitars are often the most preferred instrument, ukuleles offer greater accessibility due to their simplicity, affordability, and suitability for younger users. The STRUM intervention consists of virtual active music therapy ukulele lessons, which may be a feasible and acceptable way to improve radiation induced cognitive decline for adolescents undergoing radiation therapy for cancer treatment.",[18,19,20,21],"Childhood Hematopoietic and Lymphatic System Neoplasm","Childhood Malignant Solid Neoplasm","Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},30,"ESTIMATED",[31,36,41],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Interview","Ancillary studies",[35],"Supportive care (STRUM sessions)",{"type":37,"name":38,"description":39,"armGroupLabels":40},"PROCEDURE","Music Therapy","Attend STRUM sessions",[35],{"type":14,"name":42,"description":33,"armGroupLabels":43},"Survey Administration",[35],[45,49,53,56,60,64,67],{"measure":46,"description":47,"timeFrame":48},"Percentage of eligible participants who consent to participate in this study (feasibility)","Feasibility defined as achieving a ≥ 70% consent rate among eligible participants.","At time of enrollment",{"measure":50,"description":51,"timeFrame":52},"Proportion of STRUM sessions completed (feasibility)","Participants will receive 10 weekly 30-minute virtual ukulele lessons over ten weeks. Basic descriptive statistical analyses will be performed.","Up to 10 weeks",{"measure":54,"description":55,"timeFrame":52},"Average weekly practice minutes","Assessed by patient self-report. Participants will be encouraged to practice their skills independently for at least 90 minutes per week. Basic descriptive statistical analyses will be performed.",{"measure":57,"description":58,"timeFrame":59},"Percentage of participants who complete ≥ 90% of the measures at each timepoint (feasibility)","Basic descriptive statistical analyses will be performed.","Baseline, week 6, week 12, week 20",{"measure":61,"description":62,"timeFrame":63},"Acceptability of the Strengthening Teen Brain Resilience Using Music (STRUM) intervention","Defined as mean Acceptability of Intervention Measure (AIM) score of ≥ 3\u002F4, supported by exit interview feedback. Basic descriptive statistical analyses will be performed. The AIM is a study-specific measure that consists of 4 questions, each answered on a scale of 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability.","Approximately 2 weeks following end of intervention (week 12)",{"measure":65,"description":66,"timeFrame":63},"Participant perspective on meaningfulness of the STRUM intervention","Assessed by exit interview feedback. Participants will complete semi-structured exit interviews (approximately 30-minute duration). Exit interview transcripts will be analyzed and coded using thematic analyses. Thematic findings will be used to refine the intervention design and delivery.",{"measure":68,"description":69,"timeFrame":59},"Change in brain resilience","Assessed by cognitive testing using the BrainCheck Assess™ digital platform. Each testing session should take approximately 15 minutes. Standard aggregate scores range from 0-200 with lower scores generally suggesting greater cognitive impairment.",[],"ALL","12 Years","17 Years",false,{"inclusion":76,"exclusion":82,"raw_text":88},[77,78,79,80,81],"Aged 12-17 years at the time of enrollment","Receiving initial radiation therapy (RT) for cancer treatment with curative intent at the Mayo Clinic Arizona","Able to provide assent","Able to read and write in English","Have access to an electronic device with videoconferencing capability",[83,84,85,86,87],"Less than three-month prognosis","Past history of RT","Self-reported visual, hearing, or cognitive impairment impeding the ability to complete the STRUM intervention","Prior receipt of ukulele or guitar lessons","Actively receiving musical instrument lessons","Inclusion Criteria:\n\n* Aged 12-17 years at the time of enrollment\n* Receiving initial radiation therapy (RT) for cancer treatment with curative intent at the Mayo Clinic Arizona\n* Able to provide assent\n* Able to read and write in English\n* Have access to an electronic device with videoconferencing capability\n\nExclusion Criteria:\n\n* Less than three-month prognosis\n* Past history of RT\n* Self-reported visual, hearing, or cognitive impairment impeding the ability to complete the STRUM intervention\n* Prior receipt of ukulele or guitar lessons\n* Actively receiving musical instrument lessons",[90],"CHILD",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":106},"Mayo Clinic in Arizona","Scottsdale","Arizona","85259","United States",[99,103],{"name":100,"role":101,"phone":102},"Robert Bennett, PhD, RN","CONTACT","480-301-4394",{"name":104,"role":105},"C. Robert Bennett, PhD, RN","PRINCIPAL_INVESTIGATOR",{"lat":107,"lon":108},33.50921,-111.89903,[110],{"name":100,"role":101,"phone":102,"email":111},"bennett.robert@mayo.edu",[113],{"name":104,"affiliation":13,"role":105},[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[18,19],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.","completed","Music Therapy for Teen Brain Resilience During Cancer Treatment","This study is looking at a program called Strengthening Teen Brain Resilience Using Music (STRUM) for teenagers aged 12-17 who are receiving radiation therapy for cancer. The goal is to see if learning to play the ukulele can help improve thinking skills and emotional well-being, which can sometimes be affected by cancer treatment. Researchers want to find out if STRUM is practical and acceptable for teens. You might be able to join if you are receiving initial radiation therapy at Mayo Clinic Arizona, can read and write in English, and have a device for video calls. The study plans to enroll 30 participants, but its current status is unclear.","The study measures participation and practice minutes for up to 10 weeks.",109,"You would attend STRUM sessions, which involve music therapy, and complete interviews and surveys. This would last for up to 10 weeks.","Not stated in the trial record.",[],"v2"]