A more detailed explanation of the study’s procedures can be found in our published protocol [18]. In the following, we include changes to the protocol in response to interim findings.
Study design
This was a single-centre, researcher-blinded randomised feasibility study involving two parallel groups. The intervention group received individual music therapy in addition to usual care. The control group received usual care only.
Randomization and masking
Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. An independent statistician conducted blocked randomization with randomly permuted block sizes, which was used to fill opaque randomization envelopes. These were stored in the clinical investigator’s locked filing cabinet at the hospice and used in sequence, thereby ensuring allocation concealment up to the point of randomization. To maintain researcher blinding, the treatment allocation was forwarded directly to the music therapist by the clinical investigator.
Setting
Participants were recruited from an 18-bed specialist palliative care unit in a hospice in Northern Ireland.
Participants
Patients were screened upon admission to the inpatient hospice unit by the clinical investigator. If they were deemed to have sufficient physical and mental capacity to take part (Eastern Cooperative Oncology Group (ECOG) performance status [19] of two or lower; Abbreviated Mental Test (AMT) Score [20] of seven or more), the clinical investigator provided them with information about the trial, including the participant information sheet. If they consented, she referred them to the researcher for potential recruitment. If, following further discussion with the researcher, the patient consented to participate, they were asked to sign an informed consent form. The researcher then informed the clinical investigator. Once recruited, the clinical investigator allocated patients to groups by opening the opaque envelopes in sequence.
After the first month, we recognised that recruitment was lower than expected. Clinical advice indicated that patients having an ECOG performance status that was worse than the initial exclusion threshold would still be capable of participating in the study, and might benefit from doing so. We therefore amended the protocol to include patients with an ECOG performance status of three or lower.
Intervention
Patients were randomly assigned to two groups. The control group received usual care, as deemed appropriate by the multidisciplinary hospice team. The experimental group received music therapy in an individual setting, delivered by a trained and registered music therapist, in addition to usual care.
A person-centred and creative music therapy approach which employed a systematic therapeutic process that included assessment, therapy and evaluation was adopted, guided by each patient’s needs, interests, preferences and energy levels, and adapted accordingly in the moment [21]. During sessions, an interactive music therapeutic approach was used, whereby the client would engage by singing, playing or listening to known music, or extemporaneously create a melody, rhythm, song or instrumental piece with the therapist’s support. The specific approach used in sessions was agreed with each participant.
Patients could choose to have a carer or significant other present during the intervention. If patients and carers wished, carers could be actively involved in the music therapy sessions.
Music therapy was conducted for up to 45 min twice a week over 3 weeks. In addition to standard clinical documentation, the music therapist completed an intervention manual [22] at the end of each session, including details on who chose the music and what strategy was used from the available suite of music therapy interventions (such as music listening, active music-making, improvising, and legacy work).
Quantitative research instrument
We used the McGill Quality of Life Questionnaire (MQoL) [15], which has been reported to have the best clinimetric quality rating, content validity, construct validity and internal consistency in a review of quality of life questionnaires for use in palliative care [23]. The MQoL is a 16 item questionnaire which is divided into five sub-measures with a varying number of questions for each sub-measure. The sub-measures are physical symptoms (3 questions), physical well-being (1), psychologic well-being (4), existential well-being (6), and support (2), with each question being scored from zero to ten by the patient. The final score is calculated as one fifth of the mean of the mean scores from each sub-measure. The higher the score, the better the quality of life of the patient and it has been suggested that a difference of 1 to 2 points in the overall score is equivalent to the difference between an average and a good day, and between a bad and an average day [24].
We also collected self-reported baseline data on the patients, including age, gender, ethnicity, marital status and their use of complementary therapies.
Analysis of outcomes
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a.
The capacity to recruit 52 patients to the study in a recruitment period of 12 months and to retain 70% of these to completion was recorded. 52 participants is a third more than the minimum recommended for good practice in a feasibility study [25] and a 30% attrition allowance is recommended for a palliative care population [26]. These figures, along with input from practitioners and carers on what would be a clinically meaningful difference, were then used to support the calculation of the required sample size for a definitive RCT.
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b.
The viability of delivering a 3 week music therapy intervention was determined by attrition figures along with reasons for attrition.
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c.
The acceptability of the MQoL questionnaire was evaluated at each data collection point by the researcher, who requested verbal feedback from all patients in relation to the acceptability of the questionnaire’s content and level of burden to complete. This verbal feedback was recorded and thematically analysed for any patterns in relation to acceptability. We also monitored and analysed the number of completed questionnaires along with reasons for non-completion using descriptive statistics.
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d.
Our initial intention was to assess potential effectiveness by determining the change over time in the MQoL, which was to be measured at baseline, at 3 weeks (i.e. after completion of music therapy) and 5 weeks (i.e. 2 weeks after completion of music therapy). However, it became apparent that many patients were not surviving long enough after recruitment to reach the 3 week time point and we therefore instigated a MQoL follow-up at 1 week, making the change from baseline to this time point the primary outcome for the effectiveness assessment in this feasibility study. In the protocol, we had envisaged using analysis of covariance to compare the change in quality of life outcomes between the two randomised groups over time. However, for simplicity and given the high attrition rates beyond the first week, we report here the unadjusted mean differences between the groups for the change from baseline to week 1. Results are shown with their associated standard deviations (SD) or 95% confidence intervals (CI). In the absence of a formal power calculation, we advise caution when interpreting our results.
Reporting
The reporting of this study follows the CONSORT extensions for abstracts and for pilot and feasibility trials.
Monitoring adverse events
A Serious adverse events (SAE) form was included in each patient’s case report form. As per protocol, any SAE was to be reported to the Principle Investigator within 24 h, and reviewed by the Trial Steering Committee (TSC) at regular intervals throughout the trial. No adverse events were reported during the trial.
Ethics approval and consent to participate
Ethical approval was provided from the Office of Research Ethics Committee Northern Ireland (ORECNI) (reference number 16/NI/0058), which also provided approval for alterations to the protocol made during the study. Patients and staff provided written informed consent prior to participation in the study.