<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03758703</url>
  </required_header>
  <id_info>
    <org_study_id>5316</org_study_id>
    <nct_id>NCT03758703</nct_id>
  </id_info>
  <brief_title>Music Intervention on Palliative Patients</brief_title>
  <official_title>Investigating Music Care Intervention On Palliative Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palliative/hospice care patients experience many negative symptoms during their time in such&#xD;
      facilities. These symptoms include, but are usually not limited to, pain, anxiety,&#xD;
      depression, and so on. This study is interested in exploring how a music intervention can be&#xD;
      used to reduce these symptoms in order to improve the quality of life for these patients.&#xD;
      Specifically, because music interventions can be costly (e.g., employing music therapists and&#xD;
      the likes of) and there is a lack of knowledge about how to properly implement music&#xD;
      interventions, we believe that it would be most cost-effective as well as effective in&#xD;
      reducing the described symptoms by introducing pre-recorded music as an intervention.&#xD;
      Patients will be given pre-recorded music which requires less training and less money but may&#xD;
      be just as effective as music interventions that do not use pre-recorded music. Patients will&#xD;
      be evaluated by administering surveys at predetermined times to measure their symptoms, and&#xD;
      interview-like questions will be administered at the end of the study to collect information&#xD;
      that will be used to inform a larger study in the future. This study will, therefore, be&#xD;
      collecting data on both how effective the intervention is and how feasible it is to use the&#xD;
      same methods for a similar larger study in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will employ a pragmatic randomized control trial design as a mixed-methods study&#xD;
      in which approximately half of the participants will be randomized into a control and the&#xD;
      other remaining half in the experimental group. Randomization sequences will be generated&#xD;
      externally and allocation concealment will be employed. Group allocation will be revealed to&#xD;
      subjects following informed consent, which is characterized by participants understanding the&#xD;
      full details of this study and any risks that may present themselves. Because of the nature&#xD;
      of the intervention, it is not possible to perform blinding and further stratification is&#xD;
      restricted due to the small sample size. Confounding variables, like those of age, gender,&#xD;
      education, and cancer-type, will be collected and controlled for during the statistical&#xD;
      analyses. In addition, palliative performance status (PPS) at baseline, and daily pain&#xD;
      medication usage during the intervention will be recorded to control for potential&#xD;
      confounders. PPS is regularly measured by hospital staff. The research team will not access&#xD;
      the resident's health records. Instead, the in-house care staff will perform this screening&#xD;
      and refer eligible participants to the research team. Participants randomized into the&#xD;
      experimental group will receive and self-select a pre-recorded music care playlist, whereas&#xD;
      those randomized into the control group will receive and self-select a pre-recorded soothing&#xD;
      poetry playlist, daily, over the course of seven days, but are free to select different&#xD;
      playlists within their intervention arm each day. The music and poetry will be delivered&#xD;
      using the same system with the same sound quality through a portable Bluetooth speaker&#xD;
      system. The speaker system will allow others to listen with the participant. Pre-recorded&#xD;
      poetry was chosen as a control intervention because it stimulates the same biological&#xD;
      auditory system as music. This is an appropriate comparison for the pre-recorded music&#xD;
      intervention because although it is delivered through the same fundamental biological&#xD;
      pathway, poetry sound waves are interpreted as non-patterned and non-musical. In contrast,&#xD;
      music sound waves are interpreted as patterned and organized. It is important to recognize&#xD;
      that, especially in the context of hospice care, it would be unethical to prevent&#xD;
      participants from using music outside of the study. This is controlled for by performing pre-&#xD;
      and post-evaluations exclusively for the session. In other words, this data will be collected&#xD;
      concurrently rather than longitudinally. Further, an additional daily involvement&#xD;
      questionnaire will be used to determine whether music has been used outside of the context of&#xD;
      this study. This will allow the research team to later control for this (e.g., when it is&#xD;
      used as a distraction technique outside of this study). At the end of each intervention,&#xD;
      which will last for 30-minutes, three validated questionnaires (hospice quality of life&#xD;
      index-revised (HQLIR), stait-trait anxiety inventory scale (STAIS), and edmonton symptom&#xD;
      assessment scale (ESAS)) will be administered in order to evaluate the effectiveness of the&#xD;
      intervention. However, one of these questionnaires will only be administered on day one,&#xD;
      three, and seven. Finally, an additional &quot;daily involvement&quot; questionnaire will be used as a&#xD;
      means to ensure that the music intervention took place. This questionnaire will be completed&#xD;
      on each of the seven days for each participant and will record their daily involvement. The&#xD;
      individual administering the above-mentioned questionnaires will remain with the resident for&#xD;
      the duration of the intervention and listen to the intervention together with the resident;&#xD;
      this holds true for both the control and experimental group. At the end of the study,&#xD;
      acceptability data measuring trial feasibility as a function of recruitment process;&#xD;
      participation/refusal rate; study measurements completion rate; and protocol adherence&#xD;
      including intervention delivery and data collection, will be collected via audio-recorded&#xD;
      semi-structured interviews with residents, families, and healthcare providers/volunteers for&#xD;
      which consent will first be collected. Resident's families will be invited by the participant&#xD;
      for involvement in processes such as listening to the intervention with the resident or being&#xD;
      present during the questionnaire process, and will be given the opportunity to consent prior&#xD;
      to engaging in the semi-structured interview. All above-mentioned questionnaires will be&#xD;
      administered by either community volunteers, study investigators, and/or hospice staff. Note&#xD;
      that all questionnaires will be de-identified. In order to correctly code questionnaires&#xD;
      based on each participant's unique study identifier, first and last names will be recorded&#xD;
      for each participant upon enrolment in the study. First and last names will be recorded on&#xD;
      the hard-copy study code sheet which will be kept in the PI's locked filing cabinet. The code&#xD;
      sheet will be used to prepare the de-identified questionnaires which will be used to collect&#xD;
      data in the community hospices. Upon completion of the study, the hard copy code sheet will&#xD;
      be destroyed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2019</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Because of the nature of the intervention, it is not possible to perform blinding/masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing changes in quality of life in palliative care patients</measure>
    <time_frame>3 days (days 1,3 and 7 of data collection)</time_frame>
    <description>Self-report Hospice Quality of Life Index-Revised (HQLI-R) questionnaire with 29 items; each question ranges from 0 to 10 (0 indicating the lowest quality and 10 indicating the highest quality). This yields a total score between 0 and 290.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing changes in symptom severity in palliative care patients</measure>
    <time_frame>7 days (days 1 through 7 of data collection)</time_frame>
    <description>Self-report Edmonton Symptom Assessment Scale-revised (ESAS-R) questionnaire with 10 items; each item ranges from 0 to 10 (0 indicating low to no severity in symptoms or that the symptom is absent, and 10 indicating the highest symptom severity). This yields a total score between 0 and 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing changes in trait and state anxiety in palliative care patients</measure>
    <time_frame>7 days (days 1 through 7 of data collection)</time_frame>
    <description>Self-report State-Trait Anxiety Inventory Scale (STAI-S) questionnaire with 20 items; each item ranges from 1 to 4 (1 indicating low to no anxiety and 4 indicating the highest anxiety). This yields a total score between 0 and 80.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing trial feasibility for a larger future RCT</measure>
    <time_frame>1 day (day 7 of data collection)</time_frame>
    <description>Trial feasibility will be collected in the form of audio-recorded semi-structured interviews to ascertain the feasibility of the method and logistics of the intervention. This knowledge will be applied to a future RCT in order to deliver the intervention more effectively and improve the data collection process.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Pre-recorded music intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will be receiving the pre-recorded music care intervention. The intervention is to be delivered once a day for 30 minutes, over one week, on a portable Bluetooth speaker system. Participants will select their own music from the list of pre-recorded songs playlist and are free to switch to another playlist within their treatment arm should they desire. This music was specifically designed for use in palliative care. Specifically, all songs are played at 60 beats per minute to mimic resting heart rate. Instrumentation was specifically chosen to be soothing and calming</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-recorded soothing poetry group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be provided pre-recorded soothing poetry which they will self-select. Participants are allowed to switch playlists within their treatment arm each day should they desire. This control group is designed to control time, attention, and placebo effect. Thus, the soothing poetry will be offered the identical time duration of listening to recorded soothing poetry readings and played at the same time the intervention group receives the pre-recorded music.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-recorded music intervention group</intervention_name>
    <description>Refer to the arm/group descriptions.</description>
    <arm_group_label>Pre-recorded music intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-recorded soothing poetry group</intervention_name>
    <description>Refer to the arm/group descriptions.</description>
    <arm_group_label>Pre-recorded soothing poetry group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking;&#xD;
&#xD;
          -  A score of 3 or higher on ESAS scale for pain and anxiety&#xD;
&#xD;
          -  Cognitively alert and competent to provide informed consent&#xD;
&#xD;
          -  A Palliative Performance Scale of at least 40/100.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a prognosis of fewer than 2 weeks or an expectation of leaving the&#xD;
             inpatient setting within a 2 week period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chelsea Mackinnon, MA, MMIE</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arbaaz A Patel</last_name>
    <phone>9055368221</phone>
    <email>patela11@mcmaster.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caleb Kim</last_name>
    <phone>2898778197</phone>
    <email>kimc1@mcmaster.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emmanuel House Good Shepherd Residential Hospice</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8R 2X5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Maria Maria Bau-Coote</last_name>
      <phone>(905) 308-8401</phone>
      <email>MBau-Coote@gsch.ca</email>
    </contact>
    <investigator>
      <last_name>Arbaaz A Patel</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caleb Kim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chelsea Mackinnon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dr Bob Kemp Hospice</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9B 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Sara Klinck</last_name>
      <phone>(905) 387-2448</phone>
      <email>saraklinck@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Arbaaz A Patel</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caleb Kim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chelsea Mackinnon, BHSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.cma.ca/sites/default/files/2018-11/the-state-of-seniors-health-care-in-canada-september-2016.pdf</url>
    <description>The State of Seniors Health Care in Canada</description>
  </link>
  <link>
    <url>http://www.hpcintegration.ca/media/51032/The%20Way%20Forward%20-%20What%20Canadians%20Say%20-%20Survey%20Report%20Final%20Dec%202013.pdf</url>
    <description>What Canadians Say: The Way Forward Survey Report</description>
  </link>
  <link>
    <url>https://tspace.library.utoronto.ca/handle/1807/17744</url>
    <description>Episodes of Relationship Completion Through Song in Palliative Care</description>
  </link>
  <reference>
    <citation>Institute of Medicine (US) Committee on Care at the End of Life; Field MJ, Cassel CK, editors. Approaching Death: Improving Care at the End of Life. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK233605/</citation>
    <PMID>25121204</PMID>
  </reference>
  <reference>
    <citation>Morrison RS, Meier DE. Clinical practice. Palliative care. N Engl J Med. 2004 Jun 17;350(25):2582-90. doi: 10.1056/NEJMcp035232. No abstract available.</citation>
    <PMID>15201415</PMID>
  </reference>
  <reference>
    <citation>O'Callaghan CC. Pain, music creativity and music therapy in palliative care. Am J Hosp Palliat Care. 1996 Mar-Apr;13(2):43-9. doi: 10.1177/104990919601300211.</citation>
    <PMID>8716327</PMID>
  </reference>
  <reference>
    <citation>Archie P, Bruera E, Cohen L. Music-based interventions in palliative cancer care: a review of quantitative studies and neurobiological literature. Support Care Cancer. 2013 Sep;21(9):2609-24. doi: 10.1007/s00520-013-1841-4. Epub 2013 May 30.</citation>
    <PMID>23715815</PMID>
  </reference>
  <reference>
    <citation>Clements-Cortes A. The use of music in facilitating emotional expression in the terminally ill. Am J Hosp Palliat Care. 2004 Jul-Aug;21(4):255-60. doi: 10.1177/104990910402100406.</citation>
    <PMID>15315187</PMID>
  </reference>
  <reference>
    <citation>Olofsson A, Fossum B. Perspectives on music therapy in adult cancer care: a hermeneutic study. Oncol Nurs Forum. 2009 Jul;36(4):E223-31. doi: 10.1188/09.ONF.E223-E231.</citation>
    <PMID>19581226</PMID>
  </reference>
  <reference>
    <citation>Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.</citation>
    <PMID>27524661</PMID>
  </reference>
  <reference>
    <citation>McMillan SC, Weitzner M. Quality of life in cancer patients: use of a revised Hospice Index. Cancer Pract. 1998 Sep-Oct;6(5):282-8. doi: 10.1046/j.1523-5394.1998.00023.x.</citation>
    <PMID>9767348</PMID>
  </reference>
  <reference>
    <citation>Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.</citation>
    <PMID>1714502</PMID>
  </reference>
  <reference>
    <citation>Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the state-trait anxiety inventory (Palo Alto, CA, Consulting Psychologists Press). Inc. 1983.</citation>
  </reference>
  <reference>
    <citation>Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.</citation>
    <PMID>20053272</PMID>
  </reference>
  <reference>
    <citation>Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014 Aug;44(8):555-8. doi: 10.2519/jospt.2014.0110. No abstract available.</citation>
    <PMID>25082389</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Arbaaz Patel</investigator_full_name>
    <investigator_title>Bachelor of Health Sciences Student at McMaster University</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only anonymized grouped data will be shared for publication once data analysis is complete.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03758703
org study id: 5316
nct id: NCT03758703
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
masking description: Because of the nature of the intervention, it is not possible to perform blinding/masking.
measure: Assessing changes in quality of life in palliative care patients
time frame: 3 days (days 1,3 and 7 of data collection)
description: Self-report Hospice Quality of Life Index-Revised (HQLI-R) questionnaire with 29 items; each question ranges from 0 to 10 (0 indicating the lowest quality and 10 indicating the highest quality). This yields a total score between 0 and 290.
measure: Assessing changes in symptom severity in palliative care patients
time frame: 7 days (days 1 through 7 of data collection)
description: Self-report Edmonton Symptom Assessment Scale-revised (ESAS-R) questionnaire with 10 items; each item ranges from 0 to 10 (0 indicating low to no severity in symptoms or that the symptom is absent, and 10 indicating the highest symptom severity). This yields a total score between 0 and 100.
measure: Assessing changes in trait and state anxiety in palliative care patients
time frame: 7 days (days 1 through 7 of data collection)
description: Self-report State-Trait Anxiety Inventory Scale (STAI-S) questionnaire with 20 items; each item ranges from 1 to 4 (1 indicating low to no anxiety and 4 indicating the highest anxiety). This yields a total score between 0 and 80.
measure: Assessing trial feasibility for a larger future RCT
time frame: 1 day (day 7 of data collection)
description: Trial feasibility will be collected in the form of audio-recorded semi-structured interviews to ascertain the feasibility of the method and logistics of the intervention. This knowledge will be applied to a future RCT in order to deliver the intervention more effectively and improve the data collection process.
arm group label: Pre-recorded music intervention group
arm group type: Experimental
description: The experimental group will be receiving the pre-recorded music care intervention. The intervention is to be delivered once a day for 30 minutes, over one week, on a portable Bluetooth speaker system. Participants will select their own music from the list of pre-recorded songs playlist and are free to switch to another playlist within their treatment arm should they desire. This music was specifically designed for use in palliative care. Specifically, all songs are played at 60 beats per minute to mimic resting heart rate. Instrumentation was specifically chosen to be soothing and calming
arm group label: Pre-recorded soothing poetry group
arm group type: Active Comparator
description: The control group will be provided pre-recorded soothing poetry which they will self-select. Participants are allowed to switch playlists within their treatment arm each day should they desire. This control group is designed to control time, attention, and placebo effect. Thus, the soothing poetry will be offered the identical time duration of listening to recorded soothing poetry readings and played at the same time the intervention group receives the pre-recorded music.
intervention type: Other
intervention name: Pre-recorded music intervention group
description: Refer to the arm/group descriptions.
arm group label: Pre-recorded music intervention group
intervention type: Other
intervention name: Pre-recorded soothing poetry group
description: Refer to the arm/group descriptions.
arm group label: Pre-recorded soothing poetry group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chelsea Mackinnon, MA, MMIE
role: Principal Investigator
affiliation: McMaster University
last name: Arbaaz A Patel
phone: 9055368221
email: patela11@mcmaster.ca
last name: Caleb Kim
phone: 2898778197
email: kimc1@mcmaster.ca
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country: Canada
url: https://www.cma.ca/sites/default/files/2018-11/the-state-of-seniors-health-care-in-canada-september-2016.pdf
description: The State of Seniors Health Care in Canada
url: http://www.hpcintegration.ca/media/51032/The%20Way%20Forward%20-%20What%20Canadians%20Say%20-%20Survey%20Report%20Final%20Dec%202013.pdf
description: What Canadians Say: The Way Forward Survey Report
url: https://tspace.library.utoronto.ca/handle/1807/17744
description: Episodes of Relationship Completion Through Song in Palliative Care
citation: Institute of Medicine (US) Committee on Care at the End of Life; Field MJ, Cassel CK, editors. Approaching Death: Improving Care at the End of Life. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK233605/
PMID: 25121204
citation: Morrison RS, Meier DE. Clinical practice. Palliative care. N Engl J Med. 2004 Jun 17;350(25):2582-90. doi: 10.1056/NEJMcp035232. No abstract available.
PMID: 15201415
citation: O'Callaghan CC. Pain, music creativity and music therapy in palliative care. Am J Hosp Palliat Care. 1996 Mar-Apr;13(2):43-9. doi: 10.1177/104990919601300211.
PMID: 8716327
citation: Archie P, Bruera E, Cohen L. Music-based interventions in palliative cancer care: a review of quantitative studies and neurobiological literature. Support Care Cancer. 2013 Sep;21(9):2609-24. doi: 10.1007/s00520-013-1841-4. Epub 2013 May 30.
PMID: 23715815
citation: Clements-Cortes A. The use of music in facilitating emotional expression in the terminally ill. Am J Hosp Palliat Care. 2004 Jul-Aug;21(4):255-60. doi: 10.1177/104990910402100406.
PMID: 15315187
citation: Olofsson A, Fossum B. Perspectives on music therapy in adult cancer care: a hermeneutic study. Oncol Nurs Forum. 2009 Jul;36(4):E223-31. doi: 10.1188/09.ONF.E223-E231.
PMID: 19581226
citation: Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.
PMID: 27524661
citation: McMillan SC, Weitzner M. Quality of life in cancer patients: use of a revised Hospice Index. Cancer Pract. 1998 Sep-Oct;6(5):282-8. doi: 10.1046/j.1523-5394.1998.00023.x.
PMID: 9767348
citation: Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.
PMID: 1714502
citation: Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the state-trait anxiety inventory (Palo Alto, CA, Consulting Psychologists Press). Inc. 1983.
citation: Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.
PMID: 20053272
citation: Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014 Aug;44(8):555-8. doi: 10.2519/jospt.2014.0110. No abstract available.
PMID: 25082389
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Arbaaz Patel
investigator title: Bachelor of Health Sciences Student at McMaster University
sharing ipd: No
ipd description: Only anonymized grouped data will be shared for publication once data analysis is complete.