<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/NCT04427215</url>
  </required_header>
  <id_info>
    <org_study_id>S-169</org_study_id>
    <nct_id>NCT04427215</nct_id>
  </id_info>
  <brief_title>Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients</brief_title>
  <official_title>Effects of Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients and Their Family Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klaipėda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health of The Republic of Lithuania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Klaipėda 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>
      During cancer treatment, several patient experience substantial psychological distress,&#xD;
      mainly depression and anxiety, which can persist over years after completion of treatment.&#xD;
&#xD;
      Complementary and alternative medicine (CAM) has been in use among cancer patients for a long&#xD;
      time and several types of CAM that are practiced in various parts of the world.&#xD;
&#xD;
      However, the effectiveness of different CAM therapies on mental health is still limited.&#xD;
&#xD;
      Therefore, the investigators want to assess the effectiveness of complementary and&#xD;
      alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy&#xD;
      and Physical Activity) on mental health of cancer patients as well as their caregiver&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During cancer treatment, several patient experience substantial psychological distress,&#xD;
      mainly depression and anxiety, which can persist over years after completion of treatment.&#xD;
      These psychological impairments can aggravate symptom burden and can seriously affect&#xD;
      health-related quality of life. Likewise, the diagnosis of cancer has not only a significant&#xD;
      impact on the affected patients, but also on their families, and may cause emotional&#xD;
      responses of shock, doubt, anxiety, and depression.&#xD;
&#xD;
      Complementary and alternative medicine (CAM) has been in use among cancer patients for a long&#xD;
      time and several types of CAM that are practiced in various parts of the world. In the&#xD;
      general among Lithuanian adult population, the use of CAM begins to seem common and the&#xD;
      country claim for guidelines researches and to test the effectiveness of this practice to&#xD;
      support the use of some CAM therapies on mental health of patients as well as their families.&#xD;
&#xD;
      In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase&#xD;
      the recovery and quality of life in the patients and their families. The effectiveness of&#xD;
      different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy&#xD;
      and Physical Activity ) on mental health and recovery of cancer patients as well as on&#xD;
      caregiving experiences and mental health of partners of cancer patients, it will be of great&#xD;
      value to improve and provide a more effective service and the quality of caring in this&#xD;
      patient as well as the continuing work of the Francis Oncology Center in Klaipeda and&#xD;
      partners, with more higher scientific excellence and quality .&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      · To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement&#xD;
      therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of&#xD;
      cancer patients as well as their caregiver.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 1</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>5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The participants will be randomized</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Mental health (score)changes over 4 weeks intervention</time_frame>
    <description>Questionnaire to assess mental health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Quality of life changes (score) over 4 weeks intervention</time_frame>
    <description>Questionnaire to assess quality of life</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>A - Music Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two section a week of music therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - Art Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two section a week of Art therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C - Dance-Movement Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two section a week of Dance-Movement Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D - Bibliotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two section a week of Bibliotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E - Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two section a week of systematized physical activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complementary and alternative medicines</intervention_name>
    <description>Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.</description>
    <arm_group_label>A - Music Therapy</arm_group_label>
    <arm_group_label>B - Art Therapy</arm_group_label>
    <arm_group_label>C - Dance-Movement Therapy</arm_group_label>
    <arm_group_label>D - Bibliotherapy</arm_group_label>
    <arm_group_label>E - Physical Activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All adult woman with breast cancer diagnoses and their primary family caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient physical capacity&#xD;
&#xD;
          -  Severe mental disorder&#xD;
&#xD;
          -  Inability ti give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cesar Agostinis-Sobrinho</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klaipėda University</investigator_affiliation>
    <investigator_full_name>Cesar Agostinis-Sobrinho</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT04427215
org study id: S-169
nct id: NCT04427215
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During cancer treatment, several patient experience substantial psychological distress,
      mainly depression and anxiety, which can persist over years after completion of treatment.

      Complementary and alternative medicine (CAM) has been in use among cancer patients for a long
      time and several types of CAM that are practiced in various parts of the world.

      However, the effectiveness of different CAM therapies on mental health is still limited.

      Therefore, the investigators want to assess the effectiveness of complementary and
      alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy
      and Physical Activity) on mental health of cancer patients as well as their caregiver
During cancer treatment, several patient experience substantial psychological distress,
      mainly depression and anxiety, which can persist over years after completion of treatment.
      These psychological impairments can aggravate symptom burden and can seriously affect
      health-related quality of life. Likewise, the diagnosis of cancer has not only a significant
      impact on the affected patients, but also on their families, and may cause emotional
      responses of shock, doubt, anxiety, and depression.

      Complementary and alternative medicine (CAM) has been in use among cancer patients for a long
      time and several types of CAM that are practiced in various parts of the world. In the
      general among Lithuanian adult population, the use of CAM begins to seem common and the
      country claim for guidelines researches and to test the effectiveness of this practice to
      support the use of some CAM therapies on mental health of patients as well as their families.

      In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase
      the recovery and quality of life in the patients and their families. The effectiveness of
      different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy
      and Physical Activity ) on mental health and recovery of cancer patients as well as on
      caregiving experiences and mental health of partners of cancer patients, it will be of great
      value to improve and provide a more effective service and the quality of caring in this
      patient as well as the continuing work of the Francis Oncology Center in Klaipeda and
      partners, with more higher scientific excellence and quality .

      Objectives

      · To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement
      therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of
      cancer patients as well as their caregiver.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 5 intervention groups (music therapy, art therapy, dance-movement therapy, physical activity, bibliotherapy) and 1 control group.
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: The participants will be randomized
measure: Mental Health
time frame: Mental health (score)changes over 4 weeks intervention
description: Questionnaire to assess mental health
measure: Quality of Life
time frame: Quality of life changes (score) over 4 weeks intervention
description: Questionnaire to assess quality of life
arm group label: A - Music Therapy
arm group type: Experimental
description: Two section a week of music therapy
arm group label: B - Art Therapy
arm group type: Experimental
description: Two section a week of Art therapy
arm group label: C - Dance-Movement Therapy
arm group type: Experimental
description: Two section a week of Dance-Movement Therapy
arm group label: D - Bibliotherapy
arm group type: Experimental
description: Two section a week of Bibliotherapy
arm group label: E - Physical Activity
arm group type: Experimental
description: Two section a week of systematized physical activity
intervention type: Other
intervention name: Complementary and alternative medicines
description: Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.
arm group label: A - Music Therapy
arm group label: B - Art Therapy
arm group label: C - Dance-Movement Therapy
arm group label: D - Bibliotherapy
arm group label: E - Physical Activity
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Lithuania
responsible party type: Principal Investigator
investigator affiliation: Klaipėda University
investigator full name: Cesar Agostinis-Sobrinho
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No