Palliative CareNCT02791048
Music Therapy for Palliative Care Patients
A study testing Music therapy in people with Palliative Care, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Up to 12 months
The effect of music therapy upon inter-familial communication
In the absence of a validated tool to measure this outcome the investigators propose to use qualitative interviewing of family/carers to ascertain if music therapy altered the quality of communication between them and patients.
Measured: Up to 12 months
The effect of contextual factors upon the implementation and sustainability of music therapy in a palliative care setting
Marie Curie Hospice employees with a direct patient care role will be invited to take part in a focus group. The aim is to develop an integrated outcome and process evaluation framework to advance theoretical understanding of what components of music therapy work best, for whom, and in what circumstances.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Marie Curie Hospice, Belfast, Every Day Harmony Music Therapy (Northern Ireland Music Therapy Trust)
- Responsible party
- Principal investigator, Dr Joanne Reid, Queen's University, Belfast
- Investigators
- Joanne Reid, Dr, Principal investigator, School of Nursing and Midwifery, Queen's University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791048
- Sponsor's protocol ID
- B16/27
- Status last verified
- Mar 2019
- First submitted
- 25 May 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30482192McConnell 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.
PubMed 27965885
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02791048
- Acronym / sponsor ID
- B16/27
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Marie Curie Hospice, Belfast, Every Day Harmony Music Therapy (Northern Ireland Music Therapy Trust)
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Music therapyMusic therapy for up to 45 minutes twice a week for three weeks, in addition to usual care from the hospice multidisciplinary team. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyMusic 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. | Behavioural | Experimental Group |
Primary outcome
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).
3 secondary outcomes
The effect of music therapy upon quality of life two weeks after completion of the music therapy course
Time frame: Up to 12 months
The effect of music therapy upon inter-familial communication
Time frame: Up to 12 months
The effect of contextual factors upon the implementation and sustainability of music therapy in a palliative care setting
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 30482192Porter 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.
- Derived from this study: PubMed 27965885McConnell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Reid, Dr principal investigator
School of Nursing and Midwifery, Queen's University Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Palliative Care, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.