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CancerNCT07831148

Music Therapy Program for Patients in Palliative Care (MUSPAL360)

A study testing Music Therapy with Virtual Reality (Session 1), Significant Song Choice (Session 2) and Biographical Musical Legacy (Session 3) in people with Cancer and Palliative Care, run by Austral University, Argentina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Palliative Care
What is being tested?
Music Therapy with Virtual Reality (Session 1), Significant Song Choice (Session 2) and Biographical Musical Legacy (Session 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Agustina Iturri, Phd student contact

01158540318

agustina.iturri@gmail.com

About this study

Official title: Feasibility Study of the MUSPAL360 Music Therapy Program in Adult Patients With Advanced Oncological Disease in Palliative Care at HUA

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:

Read more

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.

Read the detailed description

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.

Being tested
Music Therapy with Virtual Reality (Session 1), Significant Song Choice (Session 2), Biographical Musical Legacy (Session 3)
Keywords
music therapy, pallaitive care, Feasibility Study, Virtual Reality, Symptom Burden, Spiritual Wellbeing, Advanced Cancer, Life Review, Song Choice
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music Therapy with Virtual Reality (Session 1)Behavioural

    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.

  • Significant Song Choice (Session 2)Behavioural

    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.

  • Biographical Musical Legacy (Session 3)Behavioural

    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.

Study groups in NCT07831148
Study groupRoleWhat they receive
MUSPAL360ExperimentalAll 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
Receives: Behavioral: Music Therapy with Virtual Reality (Session 1); Behavioral: Significant Song Choice (Session 2); Behavioral: Biographical Musical Legacy (Session 3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eligibility Rate

    Proportion of patients identified by the CP team who meet inclusion criteria (progression threshold: ≥50%)

    Measured: Through study completion, an average of 15 months

  2. Consent Rate

    Proportion of eligible patients who consent to participate (≥70%)

    Measured: Through study completion, an average of 15 months

  3. Session 1 Arrival Rate

    Proportion of participants who initiate Session 1 (≥70%)

    Measured: Up to 7 days after enrollment

  4. Session 1 Completion Rate

    Proportion of initiated Session 1s completed without interruption (≥80%)

    Measured: Up to 7 days after enrollment

  5. Session 2 Arrival Rate

    Proportion of participants who initiate Session 2 (≥60%)

    Measured: Up to 7 days after enrollment

  6. Session 2 Completion Rate

    Proportion of initiated Session 2s completed without interruption (≥80%)

    Measured: Up to 7 days after enrollment

  7. Session 3 Arrival Rate

    Proportion of participants who initiate Session 3 (≥50%)

    Measured: Through study completion

  8. Session 3 Completion Rate

    Proportion of initiated Session 3s completed without interruption (≥80%)

    Measured: Through study completion, an average of 15 months

  9. Data Completeness

    Proportion of required REDCap fields completed, calculated over sessions actually performed (≥80%)

    Measured: Up to 7 days after enrollment

  10. 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%)

    Measured: Up to 7 days after enrollment

Secondary outcomes (8)
  1. 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).

    Measured: Immediately before and after each of the 3 sessions, and at program completion, up to 7 days after enrollment

  2. 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).

    Measured: Immediately before and after Session 1 only, up to 7 days after enrollment

  3. Change in Perceived Relaxation (VAS)

    Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived social support (better outcome).

    Measured: Immediately before and after Session 2 only, up to 7 days after enrollment

  4. Change in Perceived Social Support (VAS)

    Visual Analogue Scale (VAS), single item, range 0-10. Higher scores indicate greater perceived social support (better outcome).

    Measured: Immediately before and after Session 2 only, up to 7 days after enrollment

  5. 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).

    Measured: Time Frame: At program completion, up to 7 days after enrollment

  6. 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).

    Measured: At program completion, up to 7 days after enrollment

  7. Patient Subjective Experience (Qualitative)

    Explored via an opening question and optional funnel-style follow-up questions. Qualitative data, not a scale score.

    Measured: After each of the 3 sessions and at program completion, up to 7 days after enrollment

  8. Caregiver Subjective Experience (Qualitative)

    Explored via an opening question and optional funnel-style follow-up questions. Qualitative data, not a scale score.

    Measured: After each of the 3 sessions and at program completion, up to 7 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831148
Sponsor's protocol ID
MUSPAL360-2026
Other IDs
P26-043
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dneaster D, Dileo C. Levels of practice in music therapy at the end of life. In: Dileo C, Loewy J, editors. Music Therapy at the End of Life. Cherry Hill: Jeffrey Books; 2005.

  • Iturri A, Najun M, Vazquez N, Alonso-Babarro A. Music therapy interventions on symptom management in adults with advanced cancer - multisession longitudinal impact: systematic review. BMJ Support Palliat Care. 2026 Aug 28;16(5):1034-1042. doi: 10.1136/spcare-2025-005913.

    PubMed 41922094
  • Iturri A, Bertella A, Dovidas MN, Spector J, Alonso Babarro A. Music Therapy Combined with Virtual Reality Reduces Prevalent Symptoms in Adult Patients with Advanced Cancer: Randomized Clinical Trial. J Palliat Med. 2026 May;29(5):594-601. doi: 10.1177/10966218251407902. Epub 2026 Jan 9.

    PubMed 42219716

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy with Virtual Reality (Session 1), Significant Song Choice (Session 2) and Biographical Musical Legacy (Session 3) in people with Cancer and Palliative Care, run by Austral University, Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agustina Iturri, Phd student (01158540318, agustina.iturri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility Rate (time frame: Through study completion, an average of 15 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07831148, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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