<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/NCT02261558</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 16-0838</org_study_id>
    <secondary_id>09-090</secondary_id>
    <nct_id>NCT02261558</nct_id>
  </id_info>
  <brief_title>Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy</brief_title>
  <official_title>Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the impact of music therapy on newly diagnosed patients with&#xD;
      cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle&#xD;
      will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety&#xD;
      depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis&#xD;
      Scale).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to examine clinical music therapy's impact on the&#xD;
      resiliency of adults undergoing infusion therapy. This research study is being undertaken to&#xD;
      learn about how creative music therapy modalities can affect the infusion therapy process.&#xD;
      Infusion therapy often includes side effects which impact quality of life. Symptoms include&#xD;
      pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to&#xD;
      scheduling treatments and side effects. Typically patients receiving infusion therapy have no&#xD;
      alternative focus for their mind and or body aside from the Infusion itself. Since the&#xD;
      relationship between pain and anxiety is inter-related, altering one modality through a live&#xD;
      music intervention may modify the impact of the other modality thus shifting the cycle and&#xD;
      overall impact of pain and anxiety providing relief which leads to self soothing control&#xD;
      measures. The current research will enroll patients newly diagnosed with either Lung, Breast,&#xD;
      or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will&#xD;
      be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal&#xD;
      improvisation or control. All enrolled participants will complete a survey which indicates&#xD;
      their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS),&#xD;
      Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resiliency Scale</measure>
    <time_frame>At 6 months</time_frame>
    <description>Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. . The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors. Resilience as measured through quantitative scale Wagnild, &amp; Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>At 6 months</time_frame>
    <description>The HADS provides entry and final treatment endurance in coping strategies related to anxiety and depression during disease treatment trajectories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Music Psychotherapy Data Tool</measure>
    <time_frame>At 6 months</time_frame>
    <description>An informative questioner regarding the participant's musical preferences- favorite genres, artists or songs, and music history ( if applicable)- exposure to music through family members, and/or history of participation in a musical activity (such as social or private classes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>At 1 month</time_frame>
    <description>The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report &quot;current&quot; pain/stress intensity or &quot;in the last 24 hours.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>At 3 months</time_frame>
    <description>The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report &quot;current&quot; pain/stress intensity or &quot;in the last 24 hours.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>At 6 months</time_frame>
    <description>The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report &quot;current&quot; pain/stress intensity or &quot;in the last 24 hours.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Pain Scale - Color Analysis Scale (CAS)</measure>
    <time_frame>At 1 month</time_frame>
    <description>An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Pain Scale - Color Analysis Scale (CAS)</measure>
    <time_frame>At 3 months</time_frame>
    <description>An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Pain Scale - Color Analysis Scale (CAS)</measure>
    <time_frame>At 6 months</time_frame>
    <description>An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Clinical Improvisation Instrumental Music Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical Music Therapy session, 20 minutes. Focus on instrumental improvisation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Vocal Improvisation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical Music Therapy session, 20 minutes. Focus on vocal improvisation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants enrolled in control group will complete the same study design, without having a clinical music improvisation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Improvisation Instrumental Music Therapy</intervention_name>
    <description>Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes)</description>
    <arm_group_label>Clinical Improvisation Instrumental Music Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Vocal Improvisation</intervention_name>
    <description>* 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)</description>
    <arm_group_label>Clinical Vocal Improvisation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and older&#xD;
&#xD;
          -  diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18&#xD;
&#xD;
          -  past cancer(s)&#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>Joanne Loewy, MT-BC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Beth Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02261558
org study id: GCO 16-0838
secondary id: 09-090
nct id: NCT02261558
lead sponsor: 
has dmc: No
This study will investigate the impact of music therapy on newly diagnosed patients with
      cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle
      will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety
      depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis
      Scale).
The purpose of this research study is to examine clinical music therapy's impact on the
      resiliency of adults undergoing infusion therapy. This research study is being undertaken to
      learn about how creative music therapy modalities can affect the infusion therapy process.
      Infusion therapy often includes side effects which impact quality of life. Symptoms include
      pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to
      scheduling treatments and side effects. Typically patients receiving infusion therapy have no
      alternative focus for their mind and or body aside from the Infusion itself. Since the
      relationship between pain and anxiety is inter-related, altering one modality through a live
      music intervention may modify the impact of the other modality thus shifting the cycle and
      overall impact of pain and anxiety providing relief which leads to self soothing control
      measures. The current research will enroll patients newly diagnosed with either Lung, Breast,
      or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will
      be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal
      improvisation or control. All enrolled participants will complete a survey which indicates
      their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS),
      Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Resiliency Scale
time frame: At 6 months
description: Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. . The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors. Resilience as measured through quantitative scale Wagnild, & Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: At 6 months
description: The HADS provides entry and final treatment endurance in coping strategies related to anxiety and depression during disease treatment trajectories.
measure: Music Psychotherapy Data Tool
time frame: At 6 months
description: An informative questioner regarding the participant's musical preferences- favorite genres, artists or songs, and music history ( if applicable)- exposure to music through family members, and/or history of participation in a musical activity (such as social or private classes)
measure: Visual Analogue Scale (VAS)
time frame: At 1 month
description: The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
measure: Visual Analogue Scale (VAS)
time frame: At 3 months
description: The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
measure: Visual Analogue Scale (VAS)
time frame: At 6 months
description: The VAS is a single-item scale.A unidimensional measure of pain and stress intensity. A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale. Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
measure: Body Pain Scale - Color Analysis Scale (CAS)
time frame: At 1 month
description: An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
measure: Body Pain Scale - Color Analysis Scale (CAS)
time frame: At 3 months
description: An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
measure: Body Pain Scale - Color Analysis Scale (CAS)
time frame: At 6 months
description: An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure . The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
arm group label: Clinical Improvisation Instrumental Music Therapy
arm group type: Experimental
description: Clinical Music Therapy session, 20 minutes. Focus on instrumental improvisation
arm group label: Clinical Vocal Improvisation
arm group type: Experimental
description: Clinical Music Therapy session, 20 minutes. Focus on vocal improvisation
arm group label: Control Group
arm group type: No Intervention
description: Participants enrolled in control group will complete the same study design, without having a clinical music improvisation
intervention type: Other
intervention name: Clinical Improvisation Instrumental Music Therapy
description: Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes)
arm group label: Clinical Improvisation Instrumental Music Therapy
intervention type: Other
intervention name: Clinical Vocal Improvisation
description: * 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)
arm group label: Clinical Vocal Improvisation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne Loewy, MT-BC
role: Principal Investigator
affiliation: Mount Sinai Beth Israel
facility: 
country: United States
responsible party type: Sponsor