<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/NCT03782506</url>
  </required_header>
  <id_info>
    <org_study_id>3R01NR016681-02S1</org_study_id>
    <nct_id>NCT03782506</nct_id>
  </id_info>
  <brief_title>Pain Management Support Study for Cancer Survivors</brief_title>
  <official_title>The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drexel 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>
      Pain in cancer survivors is difficult to treat, and unrelieved pain can greatly reduce a&#xD;
      person's quality of life. Opioids are often prescribed for pain management, yet they can have&#xD;
      undesirable side effects and may put someone at risk for addiction or dependence. The purpose&#xD;
      of this study is to examine the impact of an interactive music therapy intervention on pain&#xD;
      management and opioid use in cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As many as 40% of cancer survivors report experiencing chronic pain, and recent research&#xD;
      indicates that pain is not well managed. Opioids are often prescribed during active cancer&#xD;
      treatment for pain management, and many cancer survivors continue the same pain management&#xD;
      regimen long after completing their cancer treatment. Reports indicate that prescription&#xD;
      rates are up to 1.22 times higher for cancer cancer survivors than people without a cancer&#xD;
      diagnosis, and the American Society of Clinical Oncology recommends that opioid tapering&#xD;
      should be a priority once someone moves into survivorship status. Music interventions have&#xD;
      been used for pain management in people with cancer, yet few studies have examined music&#xD;
      therapy for chronic pain in cancer survivors. Moreover, none of these studies have not&#xD;
      examined opioid use as a measure. Therefore, the overarching goals of this pilot study are to&#xD;
      investigate the impact of an interactive music therapy (IMT) intervention on pain management&#xD;
      and opioid use in cancer survivors with chronic pain versus a verbal-based support program&#xD;
      (social attention control). This pilot study uses a mixed methods intervention design in&#xD;
      which qualitative data (i.e. semi-structured follow-up interviews) are embedded within a&#xD;
      randomized controlled trial. We will randomize 40 cancer survivors to one of two 10-session&#xD;
      treatments: 1) Interactive Music Therapy or 2) Social Attention Control. Primary (mean daily&#xD;
      opioid use) and secondary outcomes (pain intensity, pain interference, pain-related&#xD;
      self-efficacy, patient perception of change, and physician perception of change in pain&#xD;
      management) will be measured at baseline, post-intervention and 3-month follow-up. Follow-up&#xD;
      interviews with a subsample of 12 participants and 4 physicians will enable us to gain a&#xD;
      better understanding of potential treatment benefits, learn about challenges encountered, and&#xD;
      obtain suggestions for treatment optimization. This is the first music therapy study to&#xD;
      examine the benefits of music therapy for opioid tapering in cancer survivors with chronic&#xD;
      pain and the results will be used to establish estimates of variance for sample size&#xD;
      calculations for a larger-scale randomized control trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily opioid dose</measure>
    <time_frame>Through study completion, a maximum of 28 weeks</time_frame>
    <description>Taking information from the Prescription Drug Monitoring Program, we will calculate the mean daily opioid dose for each participant by dividing the quantity of opioid pills prescribed by the number of days for which it was supplied.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported opioid use</measure>
    <time_frame>Through study completion, a maximum of 28 weeks</time_frame>
    <description>Self-report on intake of opioids and NSAIDS through daily pain medication log</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by PROMIS® Pain Intensity-Short Form (SF)3a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by PROMIS® Cancer-Pain Interference -SF 6b</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by PROMIS® Self-Efficacy of Symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception of change</measure>
    <time_frame>At post-intervention (week 10) and 3-month follow up</time_frame>
    <description>Measured by Patient Global Impression of Change Scale (PGIC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician perception of change</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>A brief questionnaire asking about their perception of how the participant is doing in terms of pain management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by the PROMIS® Emotional Distress-Anxiety - SF6a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by the PROMIS® Depression - SF 6a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>At baseline, post-intervention (week 10), and 3-month follow up</time_frame>
    <description>Measured by the PROMIS® Sleep Disturbance - SF4a</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Interactive Music Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten 45-minute individual interactive music therapy sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verbal-based Support</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ten 45-minute individual verbal support sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interactive Music Therapy</intervention_name>
    <description>Ten 45-minutes individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. Each session involves learning and practicing music-based techniques for the self-management of pain, anxiety, stress, mood, fatigue, and sleep disturbance as these are common opioid withdrawal symptoms. Psychoeducation about opioid tapering is provided and tapering challenges experienced by the patient will be actively addressed through music-based interventions.</description>
    <arm_group_label>Interactive Music Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Verbal-based support</intervention_name>
    <description>Ten 45-minute individual sessions delivered by a master's level clinician with training in counseling. The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life. The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening. The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques. The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears. As in the IMT protocol, psychoeducation about opioid tapering will be included and will be considered the only active treatment factor for this intervention.</description>
    <arm_group_label>Verbal-based Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult cancer survivors&#xD;
&#xD;
          -  chronic pain for ≥ 3 months&#xD;
&#xD;
          -  chronic opioid use (i.e., use of opioids for more than 90 days)&#xD;
&#xD;
          -  willingness to reduce the amount of opioids currently taking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of polysubstance abuse/substance use disorder&#xD;
&#xD;
          -  currently receiving methadone maintenance or suboxone treatment&#xD;
&#xD;
          -  active psychosis or dementia&#xD;
&#xD;
          -  inability to speak or write English&#xD;
&#xD;
          -  moderate to severe hearing impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joke Bradt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hahnemann University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson Sidney Kimmel Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America (CTCA)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Drexel University</investigator_affiliation>
    <investigator_full_name>Joke Bradt</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>music therapy</keyword>
  <keyword>pain management</keyword>
  <keyword>opioid use</keyword>
  <keyword>cancer survivors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will make the de-identified datasets available to other researchers. Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After completion of study report and publication of the results</ipd_time_frame>
    <ipd_access_criteria>We will make the de-identified datasets available to other researchers. Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
  </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/NCT03782506
org study id: 3R01NR016681-02S1
nct id: NCT03782506
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain in cancer survivors is difficult to treat, and unrelieved pain can greatly reduce a
      person's quality of life. Opioids are often prescribed for pain management, yet they can have
      undesirable side effects and may put someone at risk for addiction or dependence. The purpose
      of this study is to examine the impact of an interactive music therapy intervention on pain
      management and opioid use in cancer survivors.
As many as 40% of cancer survivors report experiencing chronic pain, and recent research
      indicates that pain is not well managed. Opioids are often prescribed during active cancer
      treatment for pain management, and many cancer survivors continue the same pain management
      regimen long after completing their cancer treatment. Reports indicate that prescription
      rates are up to 1.22 times higher for cancer cancer survivors than people without a cancer
      diagnosis, and the American Society of Clinical Oncology recommends that opioid tapering
      should be a priority once someone moves into survivorship status. Music interventions have
      been used for pain management in people with cancer, yet few studies have examined music
      therapy for chronic pain in cancer survivors. Moreover, none of these studies have not
      examined opioid use as a measure. Therefore, the overarching goals of this pilot study are to
      investigate the impact of an interactive music therapy (IMT) intervention on pain management
      and opioid use in cancer survivors with chronic pain versus a verbal-based support program
      (social attention control). This pilot study uses a mixed methods intervention design in
      which qualitative data (i.e. semi-structured follow-up interviews) are embedded within a
      randomized controlled trial. We will randomize 40 cancer survivors to one of two 10-session
      treatments: 1) Interactive Music Therapy or 2) Social Attention Control. Primary (mean daily
      opioid use) and secondary outcomes (pain intensity, pain interference, pain-related
      self-efficacy, patient perception of change, and physician perception of change in pain
      management) will be measured at baseline, post-intervention and 3-month follow-up. Follow-up
      interviews with a subsample of 12 participants and 4 physicians will enable us to gain a
      better understanding of potential treatment benefits, learn about challenges encountered, and
      obtain suggestions for treatment optimization. This is the first music therapy study to
      examine the benefits of music therapy for opioid tapering in cancer survivors with chronic
      pain and the results will be used to establish estimates of variance for sample size
      calculations for a larger-scale randomized control trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Daily opioid dose
time frame: Through study completion, a maximum of 28 weeks
description: Taking information from the Prescription Drug Monitoring Program, we will calculate the mean daily opioid dose for each participant by dividing the quantity of opioid pills prescribed by the number of days for which it was supplied.
measure: Self-reported opioid use
time frame: Through study completion, a maximum of 28 weeks
description: Self-report on intake of opioids and NSAIDS through daily pain medication log
measure: Pain intensity
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by PROMIS® Pain Intensity-Short Form (SF)3a
measure: Pain interference
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by PROMIS® Cancer-Pain Interference -SF 6b
measure: Self-efficacy
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by PROMIS® Self-Efficacy of Symptoms
measure: Patient perception of change
time frame: At post-intervention (week 10) and 3-month follow up
description: Measured by Patient Global Impression of Change Scale (PGIC)
measure: Physician perception of change
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: A brief questionnaire asking about their perception of how the participant is doing in terms of pain management
measure: Anxiety
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by the PROMIS® Emotional Distress-Anxiety - SF6a
measure: Depression
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by the PROMIS® Depression - SF 6a
measure: Sleep quality
time frame: At baseline, post-intervention (week 10), and 3-month follow up
description: Measured by the PROMIS® Sleep Disturbance - SF4a
arm group label: Interactive Music Therapy
arm group type: Experimental
description: Ten 45-minute individual interactive music therapy sessions.
arm group label: Verbal-based Support
arm group type: Active Comparator
description: Ten 45-minute individual verbal support sessions.
intervention type: Behavioral
intervention name: Interactive Music Therapy
description: Ten 45-minutes individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. Each session involves learning and practicing music-based techniques for the self-management of pain, anxiety, stress, mood, fatigue, and sleep disturbance as these are common opioid withdrawal symptoms. Psychoeducation about opioid tapering is provided and tapering challenges experienced by the patient will be actively addressed through music-based interventions.
arm group label: Interactive Music Therapy
intervention type: Behavioral
intervention name: Verbal-based support
description: Ten 45-minute individual sessions delivered by a master's level clinician with training in counseling. The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life. The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening. The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques. The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears. As in the IMT protocol, psychoeducation about opioid tapering will be included and will be considered the only active treatment factor for this intervention.
arm group label: Verbal-based Support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joke Bradt, PhD
role: Principal Investigator
affiliation: Drexel University
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Drexel University
investigator full name: Joke Bradt
investigator title: Professor
mesh term: Chronic Pain
sharing ipd: Yes
ipd description: We will make the de-identified datasets available to other researchers. Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
ipd info type: Study Protocol
ipd time frame: After completion of study report and publication of the results
ipd access criteria: We will make the de-identified datasets available to other researchers. Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.