Music Therapy for Cancer Patients(Meraki_PC) (Meraki_Cancer)

Meraki: Music Therapy Protocol for People With Palliative Care

The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.

Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out.

Study Overview

• Status: Completed
• Conditions: Cancer; Palliative Care
• Intervention / Treatment: Behavioral: MERAKI_PC

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Serra, Valencia, Spain
      • Hospital Dr. Moliner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is receiving palliative care for an oncological diagnosis and was admitted to the hospital a week ago. They do not have moderate to severe cognitive impairment. This treatment is for oncological patients in an advanced stage who are receiving palliative anti-tumour treatment such as chemotherapy and/or radiotherapy. These patients require support treatment that cannot be provided at home due to their complexity. The patient is in an advanced or terminal phase of the disease according to WHO criteria.
• Be over 18 years of age.
• Have preserved cognitive ability (SPMSQ, Pfeiffer). More than 2 errors (3 in illiterate persons) would suggest the presence of cognitive impairment.
• Have signed the informed consent form
• Have completed at least 2 of the 3 treatment sessions and have completed the pre-test and post-test assessment.

Exclusion Criteria:

-Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental: Experimental group; The study will commence with an initial evaluation (T1) one week after the patients' admission to the hospital. After an equal amount of time has passed without receiving any treatment, patients will undergo a re-evaluation (T2). Subsequently, patients will receive the music therapy treatment protocol, which consists of three sessions. Finally, patients will undergo a third evaluation (T3) after completing the treatment. Patients will undergo assessment before and after each music therapy session. Before the session, they will report their physical and emotional state, as well as their memory of the previous session's effects. After the session, they will be evaluated on their physical and emotional state, as well as the perceived effects of the current session. The therapy will consist of three individual sessions.	Behavioral: MERAKI_PC; The three music therapy sessions focus on helping the patient to adjust to their situation. The aim is to provide emotional support and encourage communication between family members through music. In addition, the therapy will help the patient to appreciate their remaining abilities and encourage their involvement in the rehabilitation process. The second session focuses on living in the present through re-identification. The session aims to improve the symptoms associated with the illness by focusing on the present situation and encouraging expression. The main aim of the final session, 'The Journey of Life - Leaving a Mark', is to recapitulate and provide support. Songs are used during the session, taking into account musical preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (T1, T2 and T4)	EORTC QLQ-C30. It is the most widely used quality of life questionnaire in clinical trials in Europe. It is a cancer-specific questionnaire consisting of 30 items assessing quality of life. Higher scores indicate poorer quality of life for patients.	Baseline up to 1 month
Change in emotional distress (T1, T2, T3 and T4)	The patient's overall rating of emotional distress (distress) experienced can be measured using a single-item visual analogue scale that scores from 0 to 10.	Baseline up to 1 month
Change in Anxiety and Depression Symptomatology (T1, T2 and T4)	HADS: This instrument evaluates affective disorders in non-psychiatric hospital settings. It comprises 14 items with a 4-point Likert-type response format (ranging from 0 to 3). Higher scores indicate more severe symptoms of anxiety and depression.	Baseline up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	The purpose of this assessment is to evaluate the patient's functional independence. It involves assessing their ability to perform 10 activities of daily living, including eating, washing, dressing, grooming, bowel movements, urination, toileting, transferring, ambulation, and stair use. The scores range from 0, indicating maximum dependence, to 100, indicating maximum independence.	Baseline
Pfeiffer Short Form Mental State Questionnaire, SPMSQ	This assessment evaluates cognitive impairment through a series of 10 questions that explore orientation, remote and working memory, as well as calculation skills. Each incorrectly answered question adds one point, and more than 2 errors suggest the presence of cognitive impairment that requires further study.	Baseline
Change in Resilience (T1 and T4)	Brief Resilient Coping Scale. This is a 4-item scale adapted to the Spanish context. Each item is scored on a 5-point scale, from 1 ("strongly agree") to 5 ("strongly disagree"). Higher scores reflect greater resilience.	Baseline up to 1 month
Change in Spirituality (T1 and T4)	GES questionnaire: this instrument is composed of 6 open-ended questions designed to facilitate trust and disclosure of the patient, his biography and inner world, followed by 8 items assessing spirituality as a general factor through 3 spiritual dimensions: intrapersonal, interpersonal and transpersonal. The patient responds by indicating the extent to which they identify with the items, with answers ranging from 0 (indicating 'not at all') to 4 (indicating 'very much'). A higher score indicates a greater feeling of spirituality.	Baseline up to 1 month
Change Knowledge of the disease (T1 and T4)	Clinician's assessment of the degree of acceptance, understanding, response difficulties and perception of the potential benefits of the application of the tool to patients.	Baseline up to 1 month
Charlson Comorbidity Index (CCI)	This tool predicts the one-year mortality rate for patients with various comorbid conditions, including heart disease, AIDS, and cancer (a total of 8 conditions in the short version). The measure assigns a score to each condition based on the associated risk of death. A score of 0 to 1 indicates no comorbidity, 2 points indicates low comorbidity, and 3 points or more indicates high comorbidity. The total score predicts mortality.	Baseline
Change in Social Suport (T1 and T4)	MOS: is the most appropriate instrument available in daily practice to study and evaluate social suport. By means of 20 items, it provides information on the emotional, instrumental, affective and positive social interaction dimensions, as well as offering an overall index of social support. A higher score indicates more social support.	Baseline up to 1 month

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Marián Pérez Marín, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: palliative care; cancer; psychological intervention; music therapy-based treatment
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Meraki_Palliative Care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No