Feasibility Study of the MUSPAL360 Music Therapy Program in Adult Patients With Advanced Oncological Disease in Palliative Care at HUA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Eligibility Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
MUSPAL360
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
干预措施: Music Therapy with Virtual Reality (Session 1) (Behavioral)
MUSPAL360
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
干预措施: Significant Song Choice (Session 2) (Behavioral)
MUSPAL360
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
干预措施: Biographical Musical Legacy (Session 3) (Behavioral)
结局指标
主要结局
Eligibility Rate
时间窗: Through study completion, an average of 15 months
Proportion of patients identified by the CP team who meet inclusion criteria (progression threshold: ≥50%)
Consent Rate
时间窗: Through study completion, an average of 15 months
Proportion of eligible patients who consent to participate (≥70%)
Session 1 Arrival Rate
时间窗: Up to 7 days after enrollment
Proportion of participants who initiate Session 1 (≥70%)
Session 1 Completion Rate
时间窗: Up to 7 days after enrollment
Proportion of initiated Session 1s completed without interruption (≥80%)
Session 2 Arrival Rate
时间窗: Up to 7 days after enrollment
Proportion of participants who initiate Session 2 (≥60%)
Session 2 Completion Rate
时间窗: Up to 7 days after enrollment
Proportion of initiated Session 2s completed without interruption (≥80%)
Session 3 Arrival Rate
时间窗: Through study completion
Proportion of participants who initiate Session 3 (≥50%)
Session 3 Completion Rate
时间窗: Through study completion, an average of 15 months
Proportion of initiated Session 3s completed without interruption (≥80%)
Data Completeness
时间窗: Up to 7 days after enrollment
Proportion of required REDCap fields completed, calculated over sessions actually performed (≥80%)
Adverse Event Rate
时间窗: Up to 7 days after enrollment
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%)
次要结局
- Change in Global Symptom Burden (ESAS-r)(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)(Immediately before and after Session 1 only, up to 7 days after enrollment)
- Change in Perceived Relaxation (VAS)(Immediately before and after Session 2 only, up to 7 days after enrollment)
- Change in Perceived Social Support (VAS)(Immediately before and after Session 2 only, up to 7 days after enrollment)
- Patient Global Rating of the Program(Time Frame: At program completion, up to 7 days after enrollment)
- Caregiver Global Rating of the Program(At program completion, up to 7 days after enrollment)
- Patient Subjective Experience (Qualitative)(After each of the 3 sessions and at program completion, up to 7 days after enrollment)
- Caregiver Subjective Experience (Qualitative)(After each of the 3 sessions and at program completion, up to 7 days after enrollment)
研究者
Maria Julia Cremona
MD
Austral University, Argentina