Music Therapy Program for Patients in Palliative Care (MUSPAL360)

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.

Music 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.

To 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/Ave between 0.916 and 1.000 across all professional groups.

This 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.

As 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.

Sample 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.

Inclusion criteria

• 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)

Exclusion criteria

• 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