Music Therapy Program for Patients in Palliative Care (MUSPAL360)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustral University, Argentina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Music Therapy with Virtual Reality (Session 1)
BehavioralFirst 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)
BehavioralSecond 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)
BehavioralThird 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MUSPAL360Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 months2
Consent Rate
Proportion of eligible patients who consent to participate (≥70%)
Time frame
Through study completion, an average of 15 months3
Session 1 Arrival Rate
Proportion of participants who initiate Session 1 (≥70%)
Time frame
Up to 7 days after enrollment4
Session 1 Completion Rate
Proportion of initiated Session 1s completed without interruption (≥80%)
Time frame
Up to 7 days after enrollmentSecondary outcomes
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).
Time frame
Immediately before and after each of the 3 sessions, and at program completion, up to 7 days after enrollment2
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 enrollment3
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 enrollment4
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 enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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