<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/NCT03291730</url>
  </required_header>
  <id_info>
    <org_study_id>17-377</org_study_id>
    <nct_id>NCT03291730</nct_id>
  </id_info>
  <brief_title>A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting</brief_title>
  <official_title>A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 investigators are conducting a project to provide a new type of resource called &quot;hand&#xD;
      lettering&quot; to patients receiving chemotherapy. This is a type of art therapy. The goal of&#xD;
      this project is to understand if it is feasible to use art-therapy and to describe anxiety&#xD;
      before and after completing hand-lettering.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being done to understand if it is feasible to use a form of art-therapy called&#xD;
      hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a&#xD;
      person has before and after using hand-lettering.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2018</start_date>
  <completion_date type="Actual">June 5, 2018</completion_date>
  <primary_completion_date type="Actual">June 5, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility will be defined through enrollment and completion rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe patient self-reported anxiety before and after utilizing hand-lettering</measure>
    <time_frame>2 years</time_frame>
    <description>Anxiety measured through the State Trait Anxiety Index.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Hand Lettering</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will engage in art-therapy by tracing and coloring a detailed letter or word&#xD;
Participants will also be guided through a relaxation breathing and journaling exercise that can be incorporated into the art activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breathing and journaling exercise</intervention_name>
    <description>May help reduce anxiety of receiving chemotherapy</description>
    <arm_group_label>Hand Lettering</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Art-therapy</intervention_name>
    <description>May help reduce anxiety of receiving chemotherapy</description>
    <arm_group_label>Hand Lettering</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;age 18) with a cancer diagnosis receiving oral or IV chemotherapy at&#xD;
             Dana-Farber on Yawkey 10.&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Has a minimum appointment time of 60 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Individuals with visual impairment or blindness will be excluded&#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>Cindy L Cao, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Cindy L. Cao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <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/NCT03291730
org study id: 17-377
nct id: NCT03291730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are conducting a project to provide a new type of resource called "hand
      lettering" to patients receiving chemotherapy. This is a type of art therapy. The goal of
      this project is to understand if it is feasible to use art-therapy and to describe anxiety
      before and after completing hand-lettering.
This study is being done to understand if it is feasible to use a form of art-therapy called
      hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a
      person has before and after using hand-lettering.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting
time frame: 2 years
description: Feasibility will be defined through enrollment and completion rates.
measure: Describe patient self-reported anxiety before and after utilizing hand-lettering
time frame: 2 years
description: Anxiety measured through the State Trait Anxiety Index.
arm group label: Hand Lettering
arm group type: Experimental
description: The participant will engage in art-therapy by tracing and coloring a detailed letter or word
Participants will also be guided through a relaxation breathing and journaling exercise that can be incorporated into the art activity.
intervention type: Behavioral
intervention name: Breathing and journaling exercise
description: May help reduce anxiety of receiving chemotherapy
arm group label: Hand Lettering
intervention type: Other
intervention name: Art-therapy
description: May help reduce anxiety of receiving chemotherapy
arm group label: Hand Lettering
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy L Cao, RN
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Cindy L. Cao
investigator title: Principal Investigator
sharing ipd: No