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.
abstract: BACKGROUND
  Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients.
  
  
  METHODS
  A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers.
  
  
  CONCLUSIONS
  This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT02791048.
authors.affiliation: School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland.
authors.forename: Tracey
authors.identifier: 0000-0003-1292-8597
authors.initials: T
authors.lastname: McConnell
authors.affiliation: Marie Curie Hospice Belfast, Belfast, Northern Ireland.
authors.forename: Lisa
authors.initials: L
authors.lastname: Graham-Wisener
authors.affiliation: Marie Curie Hospice Belfast, Belfast, Northern Ireland.
authors.forename: Joan
authors.initials: J
authors.lastname: Regan
authors.affiliation: Marie Curie Hospice Belfast, Belfast, Northern Ireland.
authors.forename: Miriam
authors.initials: M
authors.lastname: McKeown
authors.affiliation: Every Day Harmony Music Therapy, Belfast, Northern Ireland.
authors.forename: Jenny
authors.initials: J
authors.lastname: Kirkwood
authors.affiliation: Every Day Harmony Music Therapy, Belfast, Northern Ireland.
authors.forename: Naomi
authors.initials: N
authors.lastname: Hughes
authors.affiliation: School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: Marie Curie Hospice Belfast, Belfast, Northern Ireland.
authors.forename: Janet
authors.initials: J
authors.lastname: Leitch
authors.affiliation: Marie Curie Hospice Belfast, Belfast, Northern Ireland.
authors.forename: Kerry
authors.initials: K
authors.lastname: McGrillen
authors.affiliation: School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland.
authors.forename: Sam
authors.initials: S
authors.lastname: Porter
keywords: End-of-life care; Feasibility study; Hospice; Music therapy; Palliative care; Pilot study