Music Therapy for Cancer Patients(Meraki_PC)
- Conditions
- CancerPalliative Care
- Interventions
- Behavioral: MERAKI_PC
- Registration Number
- NCT06345924
- Lead Sponsor
- University of Valencia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
-Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group MERAKI_PC 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.
- Primary Outcome Measures
Name Time Method Change in emotional distress (T1, T2, T3 and T4) 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.
Change in Anxiety and Depression Symptomatology (T1, T2 and T4) 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.
Change in Quality of Life (T1, T2 and T4) 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.
- Secondary Outcome Measures
Name Time Method Change in Resilience (T1 and T4) 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.
Change in Spirituality (T1 and T4) 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.
Charlson Comorbidity Index (CCI) 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.
Change in Social Suport (T1 and T4) 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.
Change Knowledge of the disease (T1 and T4) 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.
Pfeiffer Short Form Mental State Questionnaire, SPMSQ 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.
Barthel Index 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.
Trial Locations
- Locations (1)
Hospital Dr. Moliner
🇪🇸Serra, Valencia, Spain