Music Therapy for Cancer Patients(Meraki_PC)

NCT06345924 | Completed

• 1 other identifier: Meraki_Palliative Care
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Palliative Care

Keywords

cancer; psychological intervention; palliative care; music therapy-based treatment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (7)

• Change in Social Suport (T1 and T4)

  Baseline up to 1 month

• Change in Resilience (T1 and T4)

  Baseline up to 1 month

• Change in Spirituality (T1 and T4)

  Baseline up to 1 month

• Change Knowledge of the disease (T1 and T4)

  Baseline up to 1 month

• Barthel Index

  Baseline

Study Arms (2)

Control Group

NO INTERVENTION

Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).

Experimental group

EXPERIMENTAL

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

Interventions

MERAKI_PC BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital Dr. Moliner

Serra, Valencia, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marián Pérez Marín, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: March 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)