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Clinical Trials/NCT02791048
NCT02791048
Completed
Not Applicable

Evaluation of the Effectiveness of Music Therapy in Improving the Quality of Life of Palliative Care Patients: a Randomised Controlled Pilot and Feasibility Study

Queen's University, Belfast1 site in 1 country51 target enrollmentApril 2016
ConditionsPalliative Care

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Palliative Care
Sponsor
Queen's University, Belfast
Enrollment
51
Locations
1
Primary Endpoint
Quality of life
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Joanne Reid

Dr

Queen's University, Belfast

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.

Outcomes

Primary Outcomes

Quality of life

Time Frame: Up to 12 months

Quality of life will be measured using the McGill Quality of Life Questionnaire: MQOL (Cohen et al., 1995), which contains 17 items, and has been shown to have the best clinimetric quality rating, content validity, construct validity and internal consistency of reviewed quality of life questionnaires in a systematic review (Albers et al., 2010). Out of 29 instruments evaluated, only the MQOL demonstrated good reliability. However, the McGill Quality of Life Questionnaire-Cardiff Short Form (MQOL-CSF: 8 items) (Pratheepawanit et al., 1999), will be considered as an alternative for the main trial if the former instrument is found to place undue burden on respondents. An analysis of the feasibility, reliability and validity of the MQOL-CSF concluded 'that the MQOL-CSF is a feasible tool with favourable psychometric properties for routine HRQoL assessment in the palliative care population' (Lua et al., 2005: 1669).

Secondary Outcomes

  • The effect of music therapy upon quality of life two weeks after completion of the music therapy course(Up to 12 months)
  • The effect of music therapy upon inter-familial communication(Up to 12 months)
  • The effect of contextual factors upon the implementation and sustainability of music therapy in a palliative care setting(Up to 12 months)

Study Sites (1)

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