CancerMeraki_CancerNCT06345924
Music Therapy for Cancer Patients(Meraki_PC)
A study testing MERAKI_PC in people with Cancer and Palliative Care, run by University of Valencia at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Palliative Care
- What is being tested?
- MERAKI_PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer, Palliative Care
- Being tested
- MERAKI_PC
- Keywords
- cancer, psychological intervention, palliative care, music therapy-based treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERAKI_PCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MERAKI_PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 1 month
Secondary outcomes (7)
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.
Measured: Baseline up to 1 month
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 1 month
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.
Measured: 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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Antonia Pérez-Marín, University of Valencia
- Investigators
- Marián Pérez Marín, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345924
- Sponsor's protocol ID
- Meraki_Palliative Care
- Acronym
- Meraki_Cancer
- Status last verified
- May 2026
- First submitted
- 28 Mar 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meraki: Music Therapy Protocol for People With Palliative Care
- ClinicalTrials.gov ID
- NCT06345924
- Acronym / sponsor ID
- Meraki_Cancer / Meraki_Palliative Care
- Conditions
- Cancer, Palliative Care
- Keywords
- cancer, psychological intervention, palliative care, music therapy-based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients who receive the treatment program, will previously constitute their own control group (waiting list control group). |
| Experimental group | Experimental | Behavioral: MERAKI_PCThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MERAKI_PCThe 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
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.
7 secondary outcomes
Change in Social Suport (T1 and T4)
Time frame: Baseline up to 1 month
Change in Resilience (T1 and T4)
Time frame: Baseline up to 1 month
Change in Spirituality (T1 and T4)
Time frame: Baseline up to 1 month
Change Knowledge of the disease (T1 and T4)
Time frame: Baseline up to 1 month
Barthel Index
Time frame: Baseline
Pfeiffer Short Form Mental State Questionnaire, SPMSQ
Time frame: Baseline
Charlson Comorbidity Index (CCI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marián Pérez Marín, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERAKI_PC in people with Cancer and Palliative Care, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety and Depression Symptomatology (T1, T2 and T4) (time frame: Baseline up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.