<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/NCT03272880</url>
  </required_header>
  <id_info>
    <org_study_id>CASE14Z17</org_study_id>
    <nct_id>NCT03272880</nct_id>
  </id_info>
  <brief_title>Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers</brief_title>
  <official_title>Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study</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>
      The purpose of this study is to evaluate the impact of arts-based programming on health,&#xD;
      well-being, and resilience. Patients who have cancer or are the caregivers of someone with&#xD;
      cancer are being asked to take part in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      To assess the feasibility and acceptability of arts-based programming for community-dwelling&#xD;
      cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:&#xD;
&#xD;
        1. Recruitment&#xD;
&#xD;
        2. Participation&#xD;
&#xD;
        3. Retention (drop-outs)&#xD;
&#xD;
        4. Satisfaction&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
      To assess the participants' ability to:&#xD;
&#xD;
        1. Define goals and strategies using the contents of the program.&#xD;
&#xD;
        2. Implement the strategies in their daily activities in the short-term.&#xD;
&#xD;
        3. Continue to use these strategies after the program ends.&#xD;
&#xD;
      Exploratory:&#xD;
&#xD;
      To perform exploratory analyses on the impact of arts-based programming on health,&#xD;
      resilience, and well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">April 13, 2018</completion_date>
  <primary_completion_date type="Actual">April 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This will be a pre-post intervention observational study utilizing a mixed methods approach</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Number of participants recruited in the study</measure>
    <time_frame>Up to 8 weeks after beginning of study</time_frame>
    <description>Study will be feasible if recruitment goal is met with 10-20 participants enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Average number of session attended by participants</measure>
    <time_frame>Up to 8 weeks after beginning of study</time_frame>
    <description>Study will be feasible if average number of session attended will be greater than or equal to 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients who drop out of study</measure>
    <time_frame>Up to 8 weeks after beginning of study</time_frame>
    <description>Study will be feasible if no more than 25% of patients drop out of study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction Score</measure>
    <time_frame>Up to 8 weeks after beginning of study</time_frame>
    <description>Satisfaction will be high in post-test surveys</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative Impact of arts-based programming on health</measure>
    <time_frame>Up to 3 weeks after final session (11 weeks from beginning of study)</time_frame>
    <description>Impact of program on health described in phenomenological interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Impact of arts based programming on resilience</measure>
    <time_frame>Up to 3 weeks after final session (11 weeks from beginning of study)</time_frame>
    <description>Impact of program on resilience described in phenomenological interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Impact of arts based programming on well-being</measure>
    <time_frame>Up to 3 weeks after final session (11 weeks from beginning of study)</time_frame>
    <description>Impact of program on well-being described in phenomenological interviews</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>arts-based programming for cancer survivors and caregivers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a 8-week, arts-based, health, resilience, and well-being program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Arts-Based Programming</intervention_name>
    <description>This feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests. The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives. The impact of this program will be assessed with qualitative follow-up interviews.</description>
    <arm_group_label>arts-based programming for cancer survivors and caregivers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to participate in all program sessions&#xD;
&#xD;
          -  Cognitively able to consent to participate&#xD;
&#xD;
          -  Speaks, reads, and writes English&#xD;
&#xD;
          -  Diagnosis of cancer or caregiver of someone with cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe visual or auditory impairment&#xD;
&#xD;
          -  Severe and/or uncontrolled comorbidity precluding safe participation in a physical&#xD;
             activity program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa M Gallagher, MA, MT-BC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Art Therapy</keyword>
  <keyword>Music Therapy</keyword>
  <!-- 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/NCT03272880
org study id: CASE14Z17
nct id: NCT03272880
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of arts-based programming on health,
      well-being, and resilience. Patients who have cancer or are the caregivers of someone with
      cancer are being asked to take part in this study.
Objective:

      Primary:

      To assess the feasibility and acceptability of arts-based programming for community-dwelling
      cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:

        1. Recruitment

        2. Participation

        3. Retention (drop-outs)

        4. Satisfaction

      Secondary:

      To assess the participants' ability to:

        1. Define goals and strategies using the contents of the program.

        2. Implement the strategies in their daily activities in the short-term.

        3. Continue to use these strategies after the program ends.

      Exploratory:

      To perform exploratory analyses on the impact of arts-based programming on health,
      resilience, and well-being.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a pre-post intervention observational study utilizing a mixed methods approach
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility: Number of participants recruited in the study
time frame: Up to 8 weeks after beginning of study
description: Study will be feasible if recruitment goal is met with 10-20 participants enrolled
measure: Feasibility: Average number of session attended by participants
time frame: Up to 8 weeks after beginning of study
description: Study will be feasible if average number of session attended will be greater than or equal to 4
measure: Percent of patients who drop out of study
time frame: Up to 8 weeks after beginning of study
description: Study will be feasible if no more than 25% of patients drop out of study
measure: Satisfaction Score
time frame: Up to 8 weeks after beginning of study
description: Satisfaction will be high in post-test surveys
measure: Qualitative Impact of arts-based programming on health
time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
description: Impact of program on health described in phenomenological interviews
measure: Qualitative Impact of arts based programming on resilience
time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
description: Impact of program on resilience described in phenomenological interviews
measure: Qualitative Impact of arts based programming on well-being
time frame: Up to 3 weeks after final session (11 weeks from beginning of study)
description: Impact of program on well-being described in phenomenological interviews
arm group label: arts-based programming for cancer survivors and caregivers
arm group type: Experimental
description: This is a 8-week, arts-based, health, resilience, and well-being program.
intervention type: Behavioral
intervention name: Arts-Based Programming
description: This feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests. The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives. The impact of this program will be assessed with qualitative follow-up interviews.
arm group label: arts-based programming for cancer survivors and caregivers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa M Gallagher, MA, MT-BC
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor