Clinical trial NCT02791048: Music Therapy for Palliative Care Patients
Official title: Evaluation of the Effectiveness of Music Therapy in Improving the Quality of Life of Palliative Care Patients: a Randomised Controlled Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Marie Curie Hospice, Belfast
name: Every Day Harmony Music Therapy (Northern Ireland Music Therapy Trust)
First posted: 2016-06-06
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find out if music therapy is effective in improving the quality of life of palliative care patients. It will do this by comparing palliative care patients who receive music therapy with those who do not receive music therapy.

Detailed description: Quality of life (QOL) is very important for palliative care patients, and includes the physical, psychological, social, and spiritual aspects of a patient's life. Music therapy is often used to help palliative care patients and there is some evidence that music therapy helps improve their quality of life, especially in relation to reducing levels of pain. Many palliative care patients and their families have also said that music therapy is helpful. However, more research is needed to help healthcare providers and funders decide if music therapy really is a useful treatment for patients receiving palliative care.

Eligibility criteria: Inclusion Criteria:

Only patients deemed able to engage with interactive music therapy will be invited to join the study. Eligibility will be assessed by a clinician during inpatient admission using the Eastern Cooperative Oncology Group (ECOG) scale and the Abbreviated Mental Test (AMT).

* Patients will be eligible if they have an ECOG performance status of 0, 1, 2 or 3 (0 indicating the patient is asymptomatic, 1 the patient is symptomatic but fully ambulatory, 2 the patient is symptomatic and confined to bed for less than 50% of the day, and 3 the patient is symptomatic and confined to bed for more than 50% of the day)) indicating they are able to engage with interactive music therapy. - Eligible patients will also have a score of 7 or more on the AMT, indicating they are capable of providing meaningful informed consent and accurate responses to the study's primary outcome measurement tool.
* Patients with communication difficulties will also be eligible if they are able to indicate their responses to the questionnaire.
* Musical skills are not required. Prior musical skills will not lead to exclusion from the study. The patient must freely consent to participation following receipt of information about the trial.

Exclusion Criteria:

* Patients will be excluded from the study if they have an ECOG performance status of 4 (4 indicating the patient is severely symptomatic and completely bedridden) or a score of 6 or less on the AMT, indicating they may not be capable of providing fully informed consent or accurate responses to the study's primary outcome measurement tool.
* Participants who decide not to consent will be excluded from the trial. Patients will be assured that this decision will have no implications for the care that they receive.

Primary outcomes:
measure: Quality of life
timeFrame: Up to 12 months
Secondary outcomes:
measure: The effect of music therapy upon quality of life two weeks after completion of the music therapy course
timeFrame: Up to 12 months
measure: The effect of music therapy upon inter-familial communication
timeFrame: Up to 12 months
measure: The effect of contextual factors upon the implementation and sustainability of music therapy in a palliative care setting
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Marie Curie Hospice
state: Co. Antrim
Study officials:
affiliation: School of Nursing and Midwifery, Queen's University Belfast
name: Joanne Reid, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porter S, McConnell T, Graham-Wisener L, Regan J, McKeown M, Kirkwood J, Clarke M, Gardner E, Dorman S, McGrillen K, Reid J. A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients. BMC Palliat Care. 2018 Nov 27;17(1):125. doi: 10.1186/s12904-018-0378-1.
citation: McConnell T, Graham-Wisener L, Regan J, McKeown M, Kirkwood J, Hughes N, Clarke M, Leitch J, McGrillen K, Porter S. Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study. Pilot Feasibility Stud. 2016 Nov 29;2:70. doi: 10.1186/s40814-016-0111-x. eCollection 2016.