An interventional study of Music Therapy with Virtual Reality (Session 1) and Significant Song Choice (Session 2) in Cancer and Palliative Care, sponsored by Austral University, Argentina. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Austral University, Argentina · Not applicable, Interventional, and Treatment
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).
MUSPAL360 includes three sessions delivered over about one week during hospitalization:
Music therapy combined with virtual reality, focused on support and relaxation. Selection of personally meaningful songs, focused on communication and expression.
Creation of a musical life story based on chronological biographical questions, focused on transformation.
Family 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.
This 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.
The 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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Austral University, Argentina is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Music Therapy with Virtual Reality (Session 1) · Behavioral: Significant Song Choice (Session 2) · Behavioral: Biographical Musical Legacy (Session 3)
First session of the MUSPAL360 program (30/40 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.
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.
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/or family via link or QR code.
Eligibility Rate
Proportion of patients identified by the CP team who meet inclusion criteria (progression threshold: ≥50%)
Time frame: Through study completion, an average of 15 months
Consent Rate
Proportion of eligible patients who consent to participate (≥70%)
Time frame: Through study completion, an average of 15 months
Session 1 Arrival Rate
Proportion of participants who initiate Session 1 (≥70%)
Time frame: Up to 7 days after enrollment
Session 1 Completion Rate
Proportion of initiated Session 1s completed without interruption (≥80%)
Time frame: Up to 7 days after enrollment
Session 2 Arrival Rate
Proportion of participants who initiate Session 2 (≥60%)
Time frame: Up to 7 days after enrollment
Session 2 Completion Rate
Proportion of initiated Session 2s completed without interruption (≥80%)
Time frame: Up to 7 days after enrollment
Session 3 Arrival Rate
Proportion of participants who initiate Session 3 (≥50%)
Time frame: Through study completion
Session 3 Completion Rate
Proportion of initiated Session 3s completed without interruption (≥80%)
Time frame: Through study completion, an average of 15 months
Data Completeness
Proportion of required REDCap fields completed, calculated over sessions actually performed (≥80%)
Time frame: Up to 7 days after enrollment
Adverse Event Rate
Proportion of sessions with adverse events attributable to the intervention (dizziness/nausea from VR headset, significant emotional distress, session interruption due to intolerance, or need for immediate clinical intervention) (\<5%)
Time frame: Up to 7 days after enrollment
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).
Time frame: Immediately before and after each of the 3 sessions, and at program completion, up to 7 days after enrollment
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).
Time frame: Immediately before and after Session 1 only, up to 7 days after enrollment
Change in Perceived Relaxation (VAS)
Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived social support (better outcome).
Time frame: Immediately before and after Session 2 only, up to 7 days after enrollment
Change in Perceived Social Support (VAS)
Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived social support (better outcome).
Time frame: Immediately before and after Session 2 only, up to 7 days after enrollment
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: Time Frame: At program completion, up to 7 days after enrollment
Caregiver 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
Patient Subjective Experience (Qualitative)
Explored via an opening question and optional funnel-style follow-up questions. Qualitative data, not a scale score.
Time frame: After each of the 3 sessions and at program completion, up to 7 days after enrollment
Caregiver Subjective Experience (Qualitative)
Explored via an opening question and optional funnel-style follow-up questions. Qualitative data, not a scale score.
Time frame: After each of the 3 sessions and at program completion, up to 7 days after enrollment
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 12 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Austral University, Argentina