Music Therapy for Cancer Patients(Meraki_PC)

Cancer Clinical Trial

— Meraki_Cancer  

Official title:

Meraki: Music Therapy Protocol for People With Palliative Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345924
• Other study ID #: Meraki_Palliative Care
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Valencia
• Contact: Marián Pérez-Marín, PhD
• Phone: 963983392
• Email: marian.perez[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Dr. Moliner	Serra	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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