<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/NCT04493034</url>
  </required_header>
  <id_info>
    <org_study_id>CASE5120</org_study_id>
    <nct_id>NCT04493034</nct_id>
  </id_info>
  <brief_title>Assessing the Benefit of Art &amp; Music Therapy on Quality of Life in Patients With Breast Cancer</brief_title>
  <official_title>A Randomized Controlled Trial to Assess the Benefit of Art &amp; Music Therapy on Quality of Life in Patients With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>
      This is a study of art-based and music-based therapy programs lasting three months (with&#xD;
      additional follow-up 3 months after the end of the trial) in breast cancer patients currently&#xD;
      receiving therapy as well as in cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cancer diagnosis is often associated with adverse psychosocial effects, including:&#xD;
      increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition,&#xD;
      and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of&#xD;
      patients; an impairment that oftentimes persists beyond completion of the regimen. This is&#xD;
      known as &quot;chemobrain&quot;. Integrative therapies are actively being investigated to help improve&#xD;
      psychological wellbeing among cancer patients and survivors.&#xD;
&#xD;
      The current standard at this institution is to inform patients of different complementary&#xD;
      services that are available, including art therapy, music therapy or acupuncture, but not&#xD;
      require patients to use them.&#xD;
&#xD;
      Participants in this study will be randomized to one of three arms 1) Art therapy program, 2)&#xD;
      Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions&#xD;
      will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and&#xD;
      remote therapy between in-person sessions. Each participant will be asked to attend two&#xD;
      in-person therapy sessions per month (total of 6).&#xD;
&#xD;
      The primary objective of this study is to determine the efficacy of a 3-month, therapist-led&#xD;
      art or music therapy program to improve quality of life in breast cancer patients currently&#xD;
      receiving therapy and in cancer survivors.&#xD;
&#xD;
      Secondary objectives of this study are:&#xD;
&#xD;
      To determine the effect of these programs on patient cognition in this population.&#xD;
&#xD;
      To determine the effect of these programs symptoms of anxiety and depression in this&#xD;
      population.&#xD;
&#xD;
      To assess whether the effect of these programs is sustained at a 3-month follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 28, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire. This is a validated survey, completed by the patient, consisting of 37 items, each scored on a 0-4, Likert scale (0 = &quot;Not at all&quot;; 4= &quot;Very much&quot;). Subscales include: Physical Well-Being (PWB) (score range: 0-28), Social/Family Well-Being (SWB) (score range: 0-28), Emotional Well-Being (EWB) (score range: 0-24), Functional Well-being (FWB) (score range: 0-28), and the additional breast cancer concerns (BCS) (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FACT-B questionnaire scores</measure>
    <time_frame>At 30-days</time_frame>
    <description>QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = &quot;Not at all&quot;; 4= &quot;Very much&quot;). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FACT-B questionnaire scores</measure>
    <time_frame>At 90-days</time_frame>
    <description>QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = &quot;Not at all&quot;; 4= &quot;Very much&quot;). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FACT-B questionnaire scores</measure>
    <time_frame>At 180-days</time_frame>
    <description>QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = &quot;Not at all&quot;; 4= &quot;Very much&quot;). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).&#xD;
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a &quot;total score&quot;, as advised by the scoring guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT-Cog questionnaire scores</measure>
    <time_frame>At 30-days</time_frame>
    <description>Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).&#xD;
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a &quot;total score&quot;, as advised by the scoring guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT-Cog questionnaire scores</measure>
    <time_frame>At 90-days</time_frame>
    <description>Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).&#xD;
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a &quot;total score&quot;, as advised by the scoring guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT-Cog questionnaire scores</measure>
    <time_frame>At 180-days</time_frame>
    <description>Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).&#xD;
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a &quot;total score&quot;, as advised by the scoring guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7 item (GAD-7) scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates &quot;not at all&quot;, 1 indicates &quot;several days&quot;, 2 indicates &quot;more than half of the days&quot;, and 3 indicates &quot;nearly every day for anxiety frequency&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7 item (GAD-7) scores</measure>
    <time_frame>At 30-days</time_frame>
    <description>Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates &quot;not at all&quot;, 1 indicates &quot;several days&quot;, 2 indicates &quot;more than half of the days&quot;, and 3 indicates &quot;nearly every day for anxiety frequency&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7 item (GAD-7) scores</measure>
    <time_frame>At 90-days</time_frame>
    <description>Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates &quot;not at all&quot;, 1 indicates &quot;several days&quot;, 2 indicates &quot;more than half of the days&quot;, and 3 indicates &quot;nearly every day for anxiety frequency&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7 item (GAD-7) scores</measure>
    <time_frame>At 180-days</time_frame>
    <description>Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates &quot;not at all&quot;, 1 indicates &quot;several days&quot;, 2 indicates &quot;more than half of the days&quot;, and 3 indicates &quot;nearly every day for anxiety frequency&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 item (PHQ-9) scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 item (PHQ-9) scores</measure>
    <time_frame>At 30-days</time_frame>
    <description>Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 item (PHQ-9) scores</measure>
    <time_frame>At 90-days</time_frame>
    <description>Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 item (PHQ-9) scores</measure>
    <time_frame>At 180-days</time_frame>
    <description>Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards art/music scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.&#xD;
Age, race/ethnicity, marital status, no. of children (if any), occupation, time since diagnosis, current chemotherapy regimen, time since therapy initiated / completed, and attitudes towards art and music will be collected as variables, to assess whether these factors are significant predictors of intervention efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards art/music scores</measure>
    <time_frame>At 30-days</time_frame>
    <description>Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards art/music scores</measure>
    <time_frame>At 90-days</time_frame>
    <description>Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards art/music scores</measure>
    <time_frame>At 180-days</time_frame>
    <description>Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Art Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Music Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A list of support services is provided. No requirement to attend sessions and no home assignments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Art Therapy</intervention_name>
    <description>The art therapist will assist each participant in producing a bound collection of participant art works/writings for personal, group and/or caregiver inspiration, at the participant's request. For in-person sessions, a variety of studio-based art and writing materials will be available for participant selection and creation. Each session will be directed in the following manner:&#xD;
New therapeutic prompt or bridge from prior session&#xD;
Creative expression, opportunity for reflection, verbal sharing / processing, and a session summary&#xD;
Discussion of action plan for the next consecutive, at-home session (weekly assignment).&#xD;
Possible wellness themes for each session (in-person or at-home) may include: mental health, physical health, emotional health, spiritual health, relational health (family and social), or occupational health/financial health.</description>
    <arm_group_label>Art Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>Participants have the opportunity to engage in: learning an instrument, active music-making, receptive music-listening, singing, improvisation, song-writing, education on music technology, or music discussion. During in-person musical sessions the six psychosocial goals promoted by the music therapist include: 1) self-care/self-love, 2) support systems, 3) practicing positivity 4) gratitude 5) mindfulness/living in the moment, and 6) goal-setting.&#xD;
For at-home assignments, participants will be asked to pick a song of the week that coincides with the theme/goal discussed in previous session(s). They will be asked to write a journal entry about the topic discussed. Journal entries can be freely written or a prompt/question can be provided. If participants do not have access to search for songs or listen to music as at home, they may select a piece from the session and be given lyrics and/or a recording on an .mp3 player returned at conclusion of study.</description>
    <arm_group_label>Music Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer diagnosis (stage 0-III)&#xD;
&#xD;
          -  Treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast&#xD;
             surgeon Patients currently undergoing treatment or have completed active treatment&#xD;
             (surgery, radiation or chemotherapy) within past 5 years.&#xD;
&#xD;
          -  Able and willing to participate in art or music therapy programs at Maroone Cancer&#xD;
             Center&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document&#xD;
&#xD;
          -  Ability to read and write in English&#xD;
&#xD;
          -  Performance status 0 or 1 as per ECOG scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior history of breast cancer&#xD;
&#xD;
          -  History of metastatic disease (Stage IV)&#xD;
&#xD;
          -  Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon&#xD;
             at Cleveland Clinic&#xD;
&#xD;
          -  Unable or unwilling to participate in art or music therapy program at Maroone Cancer&#xD;
             Center&#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>Zeina Nahleh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zeina Nahleh, MD</last_name>
    <phone>+1 954-659-5840</phone>
    <email>NAHLEHZ@ccf.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zeina Nahleh, MD</last_name>
      <phone>954-659-5840</phone>
      <email>NAHLEHZ@ccf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer Survivors</keyword>
  <keyword>Music Therapy</keyword>
  <keyword>Art Therapy</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Will share manuscripts, presentations, and abstracts</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/NCT04493034
org study id: CASE5120
nct id: NCT04493034
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study of art-based and music-based therapy programs lasting three months (with
      additional follow-up 3 months after the end of the trial) in breast cancer patients currently
      receiving therapy as well as in cancer survivors.
A cancer diagnosis is often associated with adverse psychosocial effects, including:
      increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition,
      and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of
      patients; an impairment that oftentimes persists beyond completion of the regimen. This is
      known as "chemobrain". Integrative therapies are actively being investigated to help improve
      psychological wellbeing among cancer patients and survivors.

      The current standard at this institution is to inform patients of different complementary
      services that are available, including art therapy, music therapy or acupuncture, but not
      require patients to use them.

      Participants in this study will be randomized to one of three arms 1) Art therapy program, 2)
      Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions
      will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and
      remote therapy between in-person sessions. Each participant will be asked to attend two
      in-person therapy sessions per month (total of 6).

      The primary objective of this study is to determine the efficacy of a 3-month, therapist-led
      art or music therapy program to improve quality of life in breast cancer patients currently
      receiving therapy and in cancer survivors.

      Secondary objectives of this study are:

      To determine the effect of these programs on patient cognition in this population.

      To determine the effect of these programs symptoms of anxiety and depression in this
      population.

      To assess whether the effect of these programs is sustained at a 3-month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores
time frame: Baseline
description: Quality of life (QOL) as measured by Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire. This is a validated survey, completed by the patient, consisting of 37 items, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: Physical Well-Being (PWB) (score range: 0-28), Social/Family Well-Being (SWB) (score range: 0-28), Emotional Well-Being (EWB) (score range: 0-24), Functional Well-being (FWB) (score range: 0-28), and the additional breast cancer concerns (BCS) (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
measure: FACT-B questionnaire scores
time frame: At 30-days
description: QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
measure: FACT-B questionnaire scores
time frame: At 90-days
description: QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
measure: FACT-B questionnaire scores
time frame: At 180-days
description: QOL as measured by FACT-B questionnaire scores. This is a validated survey, completed by the patient, consisting of 37 questions, each scored on a 0-4, Likert scale (0 = "Not at all"; 4= "Very much"). Subscales include: PWB (score range: 0-28), SWB (score range: 0-28), EWB (score range: 0-24), FWB (score range: 0-28), and BCS (score range: 0-40) all with higher scores indicating better outcomes. Total scale scores range from 0 to 148 with higher scores indicating better outcomes.
measure: Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores
time frame: Baseline
description: Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelines
measure: FACT-Cog questionnaire scores
time frame: At 30-days
description: Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelines
measure: FACT-Cog questionnaire scores
time frame: At 90-days
description: Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelines
measure: FACT-Cog questionnaire scores
time frame: At 180-days
description: Cognition as measured by FACT-Cog questionnaire scores. This questionnaire contains 37 items, divided into four subscales: 1) patients' perceived cognitive impairments (score range: 0-72), 2) perceived cognitive abilities (score range: 0-28), 3) Noticeability or comments from others (score range: 0-16), and 4) impact of cognitive changes on QOL (score range: 0-16).
Higher scores indicate worse perceived cognitive deficit. FACT-Cog sub-scores are studied on their own and not included in a "total score", as advised by the scoring guidelines
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
time frame: Baseline
description: Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates "not at all", 1 indicates "several days", 2 indicates "more than half of the days", and 3 indicates "nearly every day for anxiety frequency".
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
time frame: At 30-days
description: Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates "not at all", 1 indicates "several days", 2 indicates "more than half of the days", and 3 indicates "nearly every day for anxiety frequency".
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
time frame: At 90-days
description: Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates "not at all", 1 indicates "several days", 2 indicates "more than half of the days", and 3 indicates "nearly every day for anxiety frequency".
measure: Generalized Anxiety Disorder-7 item (GAD-7) scores
time frame: At 180-days
description: Self-reported anxiety as measured by GAD-7 scores. Scoring is scaled, as follows: 0 indicates "not at all", 1 indicates "several days", 2 indicates "more than half of the days", and 3 indicates "nearly every day for anxiety frequency".
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
time frame: Baseline
description: Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
time frame: At 30-days
description: Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
time frame: At 90-days
description: Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression
measure: Patient Health Questionnaire-9 item (PHQ-9) scores
time frame: At 180-days
description: Self-reported depression as measured by PHQ-9 scores. A score of 0-4 indicates no depression, a score of 5-9 indicates mild depression, a score of 10-14 indicates moderate depression, and a score of 15 or more indicates severe depression
measure: Attitudes towards art/music scores
time frame: Baseline
description: Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.
Age, race/ethnicity, marital status, no. of children (if any), occupation, time since diagnosis, current chemotherapy regimen, time since therapy initiated / completed, and attitudes towards art and music will be collected as variables, to assess whether these factors are significant predictors of intervention efficacy.
measure: Attitudes towards art/music scores
time frame: At 30-days
description: Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.
measure: Attitudes towards art/music scores
time frame: At 90-days
description: Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.
measure: Attitudes towards art/music scores
time frame: At 180-days
description: Intervention efficacy as measured by attitudes towards art/music, assessed in 4, 10-point Likert questions with scores ranging from 0 to 40, and higher scores indicating better attitudes.
arm group label: Art Therapy
arm group type: Experimental
description: Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)
arm group label: Music Therapy
arm group type: Experimental
description: Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)
arm group label: Standard Of Care
arm group type: No Intervention
description: A list of support services is provided. No requirement to attend sessions and no home assignments
intervention type: Behavioral
intervention name: Art Therapy
description: The art therapist will assist each participant in producing a bound collection of participant art works/writings for personal, group and/or caregiver inspiration, at the participant's request. For in-person sessions, a variety of studio-based art and writing materials will be available for participant selection and creation. Each session will be directed in the following manner:
New therapeutic prompt or bridge from prior session
Creative expression, opportunity for reflection, verbal sharing / processing, and a session summary
Discussion of action plan for the next consecutive, at-home session (weekly assignment).
Possible wellness themes for each session (in-person or at-home) may include: mental health, physical health, emotional health, spiritual health, relational health (family and social), or occupational health/financial health.
arm group label: Art Therapy
intervention type: Behavioral
intervention name: Music Therapy
description: Participants have the opportunity to engage in: learning an instrument, active music-making, receptive music-listening, singing, improvisation, song-writing, education on music technology, or music discussion. During in-person musical sessions the six psychosocial goals promoted by the music therapist include: 1) self-care/self-love, 2) support systems, 3) practicing positivity 4) gratitude 5) mindfulness/living in the moment, and 6) goal-setting.
For at-home assignments, participants will be asked to pick a song of the week that coincides with the theme/goal discussed in previous session(s). They will be asked to write a journal entry about the topic discussed. Journal entries can be freely written or a prompt/question can be provided. If participants do not have access to search for songs or listen to music as at home, they may select a piece from the session and be given lyrics and/or a recording on an .mp3 player returned at conclusion of study.
arm group label: Music Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zeina Nahleh, MD
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
last name: Zeina Nahleh, MD
phone: +1 954-659-5840
email: NAHLEHZ@ccf.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Will share manuscripts, presentations, and abstracts