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Completed

NCT Number: NCT06345924

Music Therapy for Cancer Patients(Meraki_PC)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Dr. Moliner

Serra, Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Anxiety and Depression Symptomatology (T1, T2 and T4)

    Time frame: Baseline up to 1 month

    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.

  2. Change in Quality of Life (T1, T2 and T4)

    Time frame: Baseline up to 1 month

    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.

  3. Change in emotional distress (T1, T2, T3 and T4)

    Time frame: Baseline up to 1 month

    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.

Secondary outcomes

  1. Change in Social Suport (T1 and T4)

    Time frame: Baseline up to 1 month

    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.

  2. Change in Resilience (T1 and T4)

    Time frame: Baseline up to 1 month

    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.

  3. Change in Spirituality (T1 and T4)

    Time frame: Baseline up to 1 month

    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.

  4. Change Knowledge of the disease (T1 and T4)

    Time frame: Baseline up to 1 month

    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.

  5. Barthel Index

    Time frame: Baseline

    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.

  6. Pfeiffer Short Form Mental State Questionnaire, SPMSQ

    Time frame: Baseline

    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.

  7. Charlson Comorbidity Index (CCI)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Meraki: Music Therapy Protocol for People With Palliative Care

Acronym: Meraki_Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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