Music Therapy for Palliative Care Patients

NCT02791048 | Completed DMC

• 1 other identifier: B16/27
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (1)

• Quality of life

  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).

  Up to 12 months

Secondary Outcomes (3)

• 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 Arms (2)

Experimental Group

EXPERIMENTAL

Music therapy for up to 45 minutes twice a week for three weeks, in addition to usual care from the hospice multidisciplinary team.

Behavioral: Music therapy

Control Group

NO INTERVENTION

Usual care only from the hospice multidisciplinary team. The dose and frequency of usual care will be as deemed appropriate by the hospice practitioner in charge of their treatment.

Interventions

Music therapy BEHAVIORAL

Music therapy is a clinical intervention conducted by qualified therapists who use shared music-making and improvisation to engage and interact with the client (s) in order to work towards specific therapeutic objectives. This is the aim of sessions, rather than the teaching or utilising of any musical skills, and clients do not have to have any prior musical training or experience whatsoever in order to participate in and benefit from music therapy. The intervention is client-led and the therapist will guide the patient in a range of strategies and activities appropriate to the therapeutic aims in place. Sessions can be individual, or family members can also be involved if appropriate and desired.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Marie Curie Hospice, Belfast: collaborator
• Every Day Harmony Music Therapy (Northern Ireland Music Therapy Trust): collaborator

Study Sites (1)

Marie Curie Hospice

Belfast, Co. Antrim, BT5 6NF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30482192 DERIVED

• 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.

  PMID: 27965885 DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joanne Reid, Dr

  School of Nursing and Midwifery, Queen's University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 6, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)