<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/NCT04442035</url>
  </required_header>
  <id_info>
    <org_study_id>B2016-043-01</org_study_id>
    <nct_id>NCT04442035</nct_id>
  </id_info>
  <brief_title>5-element Music Therapy on Patients With Breast Cancer</brief_title>
  <official_title>Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, we observed the clinical effect of using music therapy of TCM to improve the&#xD;
      status of liver depression in patients with postoperative breast cancer patients, Second we&#xD;
      want to explore the efficacy and advantages of traditional Chinese medicine in patients with&#xD;
      postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective controlled trial. Sixty-four patients were divided randomly into&#xD;
      two groups. Patients were randomly divided into the treatment group and the control group,&#xD;
      namely, the music treatment group and the health education group. The treatment group was&#xD;
      given at least 30 minutes of individual music therapy and group music therapy every 3 weeks.&#xD;
      Instead, the control group was given every 3 weeks of health education preach. It will take&#xD;
      12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning&#xD;
      and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale&#xD;
      score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we&#xD;
      take software packages SPSS 20.0 for management and statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2017</start_date>
  <completion_date type="Actual">June 3, 2018</completion_date>
  <primary_completion_date type="Actual">March 24, 2018</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months</measure>
    <time_frame>Baseline and months 3</time_frame>
    <description>The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months</measure>
    <time_frame>Baseline and months 3</time_frame>
    <description>The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Quality of Life (FACT-B score) at 3 Months</measure>
    <time_frame>Baseline and months 3</time_frame>
    <description>The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social&amp;family, emotions ; status ; breast cancer additional entries .&#xD;
The higher the score , the better state change=( months 3 score -Baseline score )</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Quality of Life</condition>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>The teatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-element misic therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>health education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>5-element music therapy</intervention_name>
    <description>participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).</description>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_label>The teatment group</arm_group_label>
    <other_name>health education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast&#xD;
             cancer during one month;&#xD;
&#xD;
          -  All participants had to have clinical depression and stagnation of liver qi;&#xD;
&#xD;
          -  age 27-66;&#xD;
&#xD;
          -  participants are conscious and willing to be followed up during the treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastasis of breast cancer or serious complications;&#xD;
&#xD;
          -  Patients with major depressive disorder;&#xD;
&#xD;
          -  The past medical history of mental disorders;&#xD;
&#xD;
          -  The primary diseases including liver, kidney, cerebrovascular, cardiovascular and&#xD;
             hematopoietic system diseases;&#xD;
&#xD;
          -  Participating in another clinical study or undergoing another intervention;&#xD;
&#xD;
          -  Patients with hearing loss.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>27 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zheng zhuanfang</last_name>
    <role>Study Chair</role>
    <affiliation>Second Clinical College of Guangzhou University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong Provincial Chinese medicine hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>music therapy</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Depression, Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04442035
org study id: B2016-043-01
nct id: NCT04442035
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, we observed the clinical effect of using music therapy of TCM to improve the
      status of liver depression in patients with postoperative breast cancer patients, Second we
      want to explore the efficacy and advantages of traditional Chinese medicine in patients with
      postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.
The study is a prospective controlled trial. Sixty-four patients were divided randomly into
      two groups. Patients were randomly divided into the treatment group and the control group,
      namely, the music treatment group and the health education group. The treatment group was
      given at least 30 minutes of individual music therapy and group music therapy every 3 weeks.
      Instead, the control group was given every 3 weeks of health education preach. It will take
      12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning
      and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale
      score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we
      take software packages SPSS 20.0 for management and statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months
time frame: Baseline and months 3
description: The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
measure: Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
time frame: Baseline and months 3
description: The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
measure: Change From Baseline in Quality of Life (FACT-B score) at 3 Months
time frame: Baseline and months 3
description: The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social&family, emotions ; status ; breast cancer additional entries .
The higher the score , the better state change=( months 3 score -Baseline score )
arm group label: The teatment group
arm group type: Experimental
description: 5-element misic therapy
arm group label: The control group
arm group type: Experimental
description: health education
intervention type: Behavioral
intervention name: 5-element music therapy
description: participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).
arm group label: The control group
arm group label: The teatment group
other name: health education
criteria: 
gender: Female
minimum age: 27 Years
maximum age: 66 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zheng zhuanfang
role: Study Chair
affiliation: Second Clinical College of Guangzhou University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Depression
sharing ipd: No