Clinical trial NCT03758703: Music Intervention on Palliative Patients
Official title: Investigating Music Care Intervention On Palliative Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will employ a pragmatic parallel randomized-control trial design as a mixed-methods study in which approximately half of the participants will be randomized into a control and the other remaining half in the experimental group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Palliative/hospice care patients experience many negative symptoms during their time in such facilities. These symptoms include, but are usually not limited to, pain, anxiety, depression, and so on. This study is interested in exploring how a music intervention can be used to reduce these symptoms in order to improve the quality of life for these patients. Specifically, because music interventions can be costly (e.g., employing music therapists and the likes of) and there is a lack of knowledge about how to properly implement music interventions, we believe that it would be most cost-effective as well as effective in reducing the described symptoms by introducing pre-recorded music as an intervention. Patients will be given pre-recorded music which requires less training and less money but may be just as effective as music interventions that do not use pre-recorded music. Patients will be evaluated by administering surveys at predetermined times to measure their symptoms, and interview-like questions will be administered at the end of the study to collect information that will be used to inform a larger study in the future. This study will, therefore, be collecting data on both how effective the intervention is and how feasible it is to use the same methods for a similar larger study in the future.

Detailed description: This study will employ a pragmatic randomized control trial design as a mixed-methods study in which approximately half of the participants will be randomized into a control and the other remaining half in the experimental group. Randomization sequences will be generated externally and allocation concealment will be employed. Group allocation will be revealed to subjects following informed consent, which is characterized by participants understanding the full details of this study and any risks that may present themselves. Because of the nature of the intervention, it is not possible to perform blinding and further stratification is restricted due to the small sample size. Confounding variables, like those of age, gender, education, and cancer-type, will be collected and controlled for during the statistical analyses. In addition, palliative performance status (PPS) at baseline, and daily pain medication usage during the intervention will be recorded to control for potential confounders. PPS is regularly measured by hospital staff. The research team will not access the resident's health records. Instead, the in-house care staff will perform this screening and refer eligible participants to the research team. Participants randomized into the experimental group will receive and self-select a pre-recorded music care playlist, whereas those randomized into the control group will receive and self-select a pre-recorded soothing poetry playlist, daily, over the course of seven days, but are free to select different playlists within their intervention arm each day. The music and poetry will be delivered using the same system with the same sound quality through a portable Bluetooth speaker system. The speaker system will allow others to listen with the participant. Pre-recorded poetry was chosen as a control intervention because it stimulates the same biological auditory system as music. This is an appropriate comparison for the pre-recorded music intervention because although it is delivered through the same fundamental biological pathway, poetry sound waves are interpreted as non-patterned and non-musical. In contrast, music sound waves are interpreted as patterned and organized. It is important to recognize that, especially in the context of hospice care, it would be unethical to prevent participants from using music outside of the study. This is controlled for by performing pre- and post-evaluations exclusively for the session. In other words, this data will be collected concurrently rather than longitudinally. Further, an additional daily involvement questionnaire will be used to determine whether music has been used outside of the context of this study. This will allow the research team to later control for this (e.g., when it is used as a distraction technique outside of this study). At the end of each intervention, which will last for 30-minutes, three validated questionnaires (hospice quality of life index-revised (HQLIR), stait-trait anxiety inventory scale (STAIS), and edmonton symptom assessment scale (ESAS)) will be administered in order to evaluate the effectiveness of the intervention. However, one of these questionnaires will only be administered on day one, three, and seven. Finally, an additional "daily involvement" questionnaire will be used as a means to ensure that the music intervention took place. This questionnaire will be completed on each of the seven days for each participant and will record their daily involvement. The individual administering the above-mentioned questionnaires will remain with the resident for the duration of the intervention and listen to the intervention together with the resident; this holds true for both the control and experimental group. At the end of the study, acceptability data measuring trial feasibility as a function of recruitment process; participation/refusal rate; study measurements completion rate; and protocol adherence including intervention delivery and data collection, will be collected via audio-recorded semi-structured interviews with residents, families, and healthcare providers/volunteers for which consent will first be collected. Resident's families will be invited by the participant for involvement in processes such as listening to the intervention with the resident or being present during the questionnaire process, and will be given the opportunity to consent prior to engaging in the semi-structured interview. All above-mentioned questionnaires will be administered by either community volunteers, study investigators, and/or hospice staff. Note that all questionnaires will be de-identified. In order to correctly code questionnaires based on each participant's unique study identifier, first and last names will be recorded for each participant upon enrolment in the study. First and last names will be recorded on the hard-copy study code sheet which will be kept in the PI's locked filing cabinet. The code sheet will be used to prepare the de-identified questionnaires which will be used to collect data in the community hospices. Upon completion of the study, the hard copy code sheet will be destroyed.

Eligibility criteria: Inclusion Criteria:

* English-speaking;
* A score of 3 or higher on ESAS scale for pain and anxiety
* Cognitively alert and competent to provide informed consent
* A Palliative Performance Scale of at least 40/100.

Exclusion Criteria:

* Participants with a prognosis of fewer than 2 weeks or an expectation of leaving the inpatient setting within a 2 week period.

Primary outcomes:
measure: Assessing changes in quality of life in palliative care patients
timeFrame: 3 days (days 1,3 and 7 of data collection)
measure: Assessing changes in symptom severity in palliative care patients
timeFrame: 7 days (days 1 through 7 of data collection)
measure: Assessing changes in trait and state anxiety in palliative care patients
timeFrame: 7 days (days 1 through 7 of data collection)
Secondary outcomes:
measure: Assessing trial feasibility for a larger future RCT
timeFrame: 1 day (day 7 of data collection)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Emmanuel House Good Shepherd Residential Hospice
state: Ontario
city: Hamilton
country: Canada
facility: Dr Bob Kemp Hospice
state: Ontario
Study officials:
affiliation: McMaster University
name: Chelsea Mackinnon, MA, MMIE
role: PRINCIPAL_INVESTIGATOR
References:
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