[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656768":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":78,"studyPopulation":70,"armGroups":79,"interventions":88,"overallOfficials":102,"centralContacts":106,"locations":70,"responsibleParty":112,"collaborators":70,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":70,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":70,"enrollmentInfo":124,"targetDuration":70,"studyType":127,"phases":128,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":143,"whyStopped":70,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":70},{"fullName":5,"class":6},"Austral University, Argentina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":42,"otherOutcomes":70},[9,13,16,20,23,26,29,33,36,39],{"measure":10,"description":11,"timeFrame":12},"Eligibility Rate","Proportion of patients identified by the CP team who meet inclusion criteria (progression threshold: ≥50%)","Through study completion, an average of 15 months",{"measure":14,"description":15,"timeFrame":12},"Consent Rate","Proportion of eligible patients who consent to participate (≥70%)",{"measure":17,"description":18,"timeFrame":19},"Session 1 Arrival Rate","Proportion of participants who initiate Session 1 (≥70%)","Up to 7 days after enrollment",{"measure":21,"description":22,"timeFrame":19},"Session 1 Completion Rate","Proportion of initiated Session 1s completed without interruption (≥80%)",{"measure":24,"description":25,"timeFrame":19},"Session 2 Arrival Rate","Proportion of participants who initiate Session 2 (≥60%)",{"measure":27,"description":28,"timeFrame":19},"Session 2 Completion Rate","Proportion of initiated Session 2s completed without interruption (≥80%)",{"measure":30,"description":31,"timeFrame":32},"Session 3 Arrival Rate","Proportion of participants who initiate Session 3 (≥50%)","Through study completion",{"measure":34,"description":35,"timeFrame":12},"Session 3 Completion Rate","Proportion of initiated Session 3s completed without interruption (≥80%)",{"measure":37,"description":38,"timeFrame":19},"Data Completeness","Proportion of required REDCap fields completed, calculated over sessions actually performed (≥80%)",{"measure":40,"description":41,"timeFrame":19},"Adverse Event Rate","Proportion of sessions with adverse events attributable to the intervention (dizziness\u002Fnausea from VR headset, significant emotional distress, session interruption due to intolerance, or need for immediate clinical intervention) (\\\u003C5%)",[43,47,51,55,57,61,64,68],{"measure":44,"description":45,"timeFrame":46},"Change in Global Symptom Burden (ESAS-r)","Edmonton Symptom Assessment System-revised (ESAS-r). Sum of 9 symptom items, each scored 0 (no symptom) to 10 (worst possible severity). Total score range: 0-90. Higher scores indicate greater symptom burden (worse outcome).","Immediately before and after each of the 3 sessions, and at program completion, up to 7 days after enrollment",{"measure":48,"description":49,"timeFrame":50},"Change in Spiritual Wellbeing (FACIT-Sp-12, Argentine validation)","Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived relaxation (better outcome).","Immediately before and after Session 1 only, up to 7 days after enrollment",{"measure":52,"description":53,"timeFrame":54},"Change in Perceived Relaxation (VAS)","Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived social support (better outcome).","Immediately before and after Session 2 only, up to 7 days after enrollment",{"measure":56,"description":53,"timeFrame":54},"Change in Perceived Social Support (VAS)",{"measure":58,"description":59,"timeFrame":60},"Patient Global Rating of the Program","Ad hoc single-item Likert scale, range 1-5. Higher scores indicate a more positive rating of the program (better outcome).","Time Frame: At program completion, up to 7 days after enrollment",{"measure":62,"description":59,"timeFrame":63},"Caregiver Global Rating of the Program","At program completion, up to 7 days after enrollment",{"measure":65,"description":66,"timeFrame":67},"Patient Subjective Experience (Qualitative)","Explored via an opening question and optional funnel-style follow-up questions. Qualitative data, not a scale score.","After each of the 3 sessions and at program completion, up to 7 days after enrollment",{"measure":69,"description":66,"timeFrame":67},"Caregiver Subjective Experience (Qualitative)",null,{"allocation":72,"interventionModel":73,"interventionModelDescription":74,"primaryPurpose":75,"observationalModel":70,"timePerspective":70,"maskingInfo":76},"NA","SINGLE_GROUP","This is a single-arm feasibility study. All eligible participants who consent receive the three-session MUSPAL360 music therapy program in addition to standard palliative care. There is no control group or randomization; the study was designed as single-arm following ethics committee guidance regarding randomization in this vulnerable, hospitalized population","TREATMENT",{"masking":77,"maskingDescription":70,"whoMasked":70},"NONE","Patients with advanced oncological disease experience a high symptom burden - including pain, fatigue, dyspnea, anxiety, and depression - that significantly impacts quality of life, functioning, and overall wellbeing. These symptoms frequently co-occur and intensify in the final months of life, creating multidimensional suffering that requires comprehensive approaches beyond conventional pharmacological management. However, evidence on structured non-pharmacological interventions in palliative care units remains scarce, representing less than 5% of published randomized controlled trials in this field.\n\nMusic therapy has shown positive effects in hospitalized oncology patients, including reductions in anxiety, depression, fatigue, and pain. A prior single-session study combining music therapy with virtual reality conducted by this research group demonstrated statistically significant reductions in prevalent symptoms compared to a no-intervention control group. However, a gap remains in the literature regarding the effectiveness of multiple-session interventions and their cumulative effects over time. A systematic review conducted by the research group identified only six controlled studies evaluating multiple-session music therapy interventions in patients with advanced cancer, revealing methodological limitations including a lack of standardized protocols, heterogeneity in intervention techniques, and small sample sizes.\n\nTo address these limitations, the MUSPAL360 program was designed following recent standardized frameworks for music-based intervention reporting, and validated through a multidisciplinary expert panel (31 experts) using the Content Validity Index, with S-CVI\u002FAve between 0.916 and 1.000 across all professional groups.\n\nThis study adopts a prospective, single-arm, pre-post design. All eligible patients who consent to participate receive the MUSPAL360 program in addition to standard palliative care, with no control group or randomization. A qualitative component is embedded within the study, collecting participants' and caregivers' subjective experience at the end of each session through a funnel-style question guide; qualitative data are analyzed independently and subsequently integrated with quantitative results.\n\nAs a feasibility study, MUSPAL360 does not test confirmatory hypotheses. Instead, pre-specified progression criteria (covering eligibility, consent, session-by-session attrition, data completeness, and adverse events) will inform the decision on whether to proceed to a future confirmatory study. The stepwise decline in expected attrition thresholds across sessions reflects the anticipated clinical deterioration typical of hospitalized palliative care populations, rather than a study design limitation.\n\nSample size was determined by the precision required to estimate feasibility metrics, not by statistical power to detect clinical effects. A minimum of 40 participants will be recruited, accounting for expected attrition at each stage of the program (approximately 20% prior to Session 1, 30% between Sessions 1 and 2, and 40-50% between Sessions 2 and 3), resulting in an estimated 13-15 evaluable participants at program completion. This sample size allows feasibility proportions to be estimated with 95% confidence intervals of approximately ±15-16 percentage points, adequate precision to guide the viability of future studies. Statistical analysis will be predominantly descriptive: progression criteria will be reported as proportions with 95% confidence intervals (Clopper-Pearson exact method), and exploratory secondary outcomes will be analyzed without correction for multiple comparisons or confirmatory interpretation.",[80],{"label":81,"type":82,"description":83,"interventionNames":84},"MUSPAL360","EXPERIMENTAL","All eligible patients who consent to participate receive the three-session MUSPAL360 music therapy program (music therapy with virtual reality, significant song choice, and biographical musical legacy) in addition to standard palliative care. There is no control group or randomization",[85,86,87],"Behavioral: Music Therapy with Virtual Reality (Session 1)","Behavioral: Significant Song Choice (Session 2)","Behavioral: Biographical Musical Legacy (Session 3)",[89,94,98],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":70},"BEHAVIORAL","Music Therapy with Virtual Reality (Session 1)","First session of the MUSPAL360 program (30\u002F40 minutes), combining live music therapy with immersive 360° virtual reality experiences (Oculus Quest 2) focused on relaxation and support. The music therapist adjusts musical parameters in real time based on the patient's vital signs. Family members may participate through guided imagery with the same live music.",[81],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":70},"Significant Song Choice (Session 2)","Second session of the MUSPAL360 program (45 minutes), using a structured guided-question format for the patient to select biographically meaningful songs, live-performed or played, followed by verbal processing of emotional experiences. Family may participate in the collaborative song selection.",[81],{"type":90,"name":99,"description":100,"armGroupLabels":101,"otherNames":70},"Biographical Musical Legacy (Session 3)","Third session of the MUSPAL360 program (45 minutes), using five chronological biographical questions to guide a musical life review. The session is audio-recorded to create a legacy playlist delivered to the patient and\u002For family via link or QR code.",[81],[103],{"name":104,"affiliation":5,"role":105},"Agustina Iturri","PRINCIPAL_INVESTIGATOR",[107],{"name":108,"role":109,"phone":110,"phoneExt":70,"email":111},"Agustina Iturri, Phd student","CONTACT","01158540318","agustina.iturri@gmail.com",{"type":105,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":70,"oldOrganization":70},"Maria Julia Cremona","MD","100656768","music-therapy-program-for-patients-in-palliative-care-muspal360-100656768",false,"NCT07831148","Music Therapy Program for Patients in Palliative Care (MUSPAL360)","Feasibility Study of the MUSPAL360 Music Therapy Program in Adult Patients With Advanced Oncological Disease in Palliative Care at HUA","Inclusion Criteria:\n\n* Adult patients ≥18 years of age with advanced cancer, defined using the NECPAL-CCOMS instrument Hospitalized in the Internal Medicine Service or the Integral Care Unit (UCIA) of HUA and attended by the Palliative Care team Expected hospital stay of at least 7 consecutive days at the time of inclusion (per treating medical team's judgment) Willing to participate and able to sign Informed Consent after receiving a full explanation from the Principal Investigator At least one symptom scoring ≥7 points on the ESAS-r scale Able to maintain alertness and adequate responsiveness during 30-45 minute sessions Able to maintain a bed position of at least 45° for use of the virtual reality headset No cognitive impairment, defined as 0-2 errors on the Short Portable Mental Status Questionnaire (SPMSQ-Pfeiffer), with correction for educational level per the original instrument Functional hearing sufficient to listen to music (with or without hearing aids)\n\nExclusion Criteria:\n\n* Patients in active agonal phase (last 48-72 hours of life, per medical team's judgment) Active, uncontrolled delirium, assessed using the Confusion Assessment Method (CAM) Epilepsy or history of photosensitive seizures Requiring palliative sedation for refractory symptoms Strict contact isolation precluding entry of musical instruments and equipment into the room","ALL","18 Years",{"count":125,"type":126},40,"ESTIMATED","INTERVENTIONAL",[72],"Hospitalized patients with advanced cancer often experience a heavy burden of physical, emotional, and spiritual symptoms that affect their quality of life. This study will evaluate whether a structured, three-session music therapy program called MUSPAL360 can be feasibly delivered to hospitalized adult patients with advanced cancer receiving palliative care at Hospital Universitario Austral (HUA).\n\nMUSPAL360 includes three sessions delivered over about one week during hospitalization:\n\nMusic therapy combined with virtual reality, focused on support and relaxation. Selection of personally meaningful songs, focused on communication and expression.\n\nCreation of a musical life story based on chronological biographical questions, focused on transformation.\n\nFamily caregivers may participate in the sessions if the patient agrees. All participants receive standard palliative care in addition to the music therapy program; there is no control group and no randomization.\n\nThis is a feasibility study, not a study designed to test whether the program works. The main goals are to determine the proportion of eligible patients, the proportion who consent to participate, how many complete each session, how complete the collected data are, and whether any adverse events occur. The study also collects preliminary, exploratory information on symptom burden and spiritual wellbeing before and after the program, to help plan the sample size of a future confirmatory study.\n\nThe researchers plan to enroll a minimum of 40 hospitalized patients, anticipating substantial attrition between sessions due to the clinical course of advanced illness in this population.",[131,132],"Cancer","Palliative Care",[134,135,136,137,138,139,140,141,142],"music therapy","pallaitive care","Feasibility Study","Virtual Reality","Symptom Burden","Spiritual Wellbeing","Advanced Cancer","Life Review","Song Choice","NOT_YET_RECRUITING","2026-09-15",{"date":146,"type":147},"2026-09-21","ACTUAL",{"date":149,"type":126},"2026-10-01",{"date":151,"type":126},"2027-12-01",{"name":5,"class":6}]