<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/NCT02982421</url>
  </required_header>
  <id_info>
    <org_study_id>0304-16-RMC</org_study_id>
    <nct_id>NCT02982421</nct_id>
  </id_info>
  <brief_title>The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors</brief_title>
  <official_title>The Effect of Group Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors Receiving Hormonal Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Art Therapy is a health profession in which art making is utilized as a means of expression&#xD;
      and communication within a therapeutic and supportive relationship [1]. Art therapy has been&#xD;
      shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms&#xD;
      which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide&#xD;
      an initial understanding of the mechanisms through which art therapy facilitates symptom&#xD;
      reduction [8]. Breast cancer patients have reported that art therapy provided them with&#xD;
      access to emotional material otherwise inaccessible [9]. The goal of this study is to examine&#xD;
      the effect of art making within a therapeutic framework on emotional awareness and&#xD;
      acceptance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life: The FACT-B (Hahn et al, 2015)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>36 item scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>20 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of Emotion Scale (AE; Weihs et al, 2008)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>13 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Approach Coping scales (Stanton et al., 2000)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>36 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Mindful Attention Awareness Scale (MAAS)(Carlson &amp; Brown, 2005).</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>15 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>20 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, &amp; Löwe, 2006)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>7 item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)</measure>
    <time_frame>Change from study start to end of intervention (8 weeks)</time_frame>
    <description>23 item scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Research</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group Art Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group art therapy</intervention_name>
    <description>Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.</description>
    <arm_group_label>Research</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult women (over age 18), breast cancer survivors without evidence of active illness,&#xD;
        hebrew speaking and receiving preventative hormonal therapy for at least 6 months (steady&#xD;
        state), receiving care at the survivor's clinic of Davidoff Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A psychiatric diagnosis requiring medication, functional difficulties that affect the&#xD;
        ability to handle art supplies, non-hebrew speaking, unwilling to answer the research&#xD;
        questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rinat Yerushalmi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Oncology Department, RMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tal Granot, MA, RN</last_name>
    <role>Study Director</role>
    <affiliation>Davidoff Cancer Center, RMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Noga Sela, BA, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Oncology, RMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvia Drier, MA, RN</last_name>
    <role>Study Director</role>
    <affiliation>Davidoff Cancer Center, RMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johanna Czamanski-Cohen, PhD</last_name>
    <phone>+972532775350</phone>
    <email>joczamanski@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rabin Medical center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Uttley L, Stevenson M, Scope A, Rawdin A, Sutton A. The clinical and cost effectiveness of group art therapy for people with non-psychotic mental health disorders: a systematic review and cost-effectiveness analysis. BMC Psychiatry. 2015 Jul 7;15:151. doi: 10.1186/s12888-015-0528-4. Erratum In: BMC Psychiatry. 2015;15:212.</citation>
    <PMID>26149275</PMID>
  </reference>
  <reference>
    <citation>Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.</citation>
    <PMID>24953449</PMID>
  </reference>
  <reference>
    <citation>Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.</citation>
    <PMID>16288447</PMID>
  </reference>
  <reference>
    <citation>Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.</citation>
    <PMID>16488349</PMID>
  </reference>
  <reference>
    <citation>Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.</citation>
    <PMID>16889324</PMID>
  </reference>
  <reference>
    <citation>Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.</citation>
    <PMID>19473224</PMID>
  </reference>
  <reference>
    <citation>Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.</citation>
    <PMID>19619378</PMID>
  </reference>
  <reference>
    <citation>Boehm K, Cramer H, Staroszynski T, Ostermann T. Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:103297. doi: 10.1155/2014/103297. Epub 2014 Feb 26.</citation>
    <PMID>24817896</PMID>
  </reference>
  <reference>
    <citation>Collie K, Bottorff JL, Long BC. A narrative view of art therapy and art making by women with breast cancer. J Health Psychol. 2006 Sep;11(5):761-75. doi: 10.1177/1359105306066632.</citation>
    <PMID>16908471</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02982421
org study id: 0304-16-RMC
nct id: NCT02982421
lead sponsor: 
has dmc: No
Art Therapy is a health profession in which art making is utilized as a means of expression
      and communication within a therapeutic and supportive relationship [1]. Art therapy has been
      shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms
      which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide
      an initial understanding of the mechanisms through which art therapy facilitates symptom
      reduction [8]. Breast cancer patients have reported that art therapy provided them with
      access to emotional material otherwise inaccessible [9]. The goal of this study is to examine
      the effect of art making within a therapeutic framework on emotional awareness and
      acceptance.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Quality of Life: The FACT-B (Hahn et al, 2015)
time frame: Change from study start to end of intervention (8 weeks)
description: 36 item scale
measure: The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
time frame: Change from study start to end of intervention (8 weeks)
description: 20 item scale
measure: Acceptance of Emotion Scale (AE; Weihs et al, 2008)
time frame: Change from study start to end of intervention (8 weeks)
description: 13 item scale
measure: Emotional Approach Coping scales (Stanton et al., 2000)
time frame: Change from study start to end of intervention (8 weeks)
description: 36 item scale
measure: The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
time frame: Change from study start to end of intervention (8 weeks)
description: 15 item scale
measure: Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
time frame: Change from study start to end of intervention (8 weeks)
description: 20 item scale
measure: The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
time frame: Change from study start to end of intervention (8 weeks)
description: 7 item scale
measure: The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
time frame: Change from study start to end of intervention (8 weeks)
description: 23 item scale
arm group label: Research
arm group type: Experimental
description: Group Art Therapy
arm group label: Control
arm group type: Sham Comparator
description: Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
intervention type: Behavioral
intervention name: Group art therapy
description: Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
arm group label: Research
intervention type: Behavioral
intervention name: Control
description: Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rinat Yerushalmi, MD
role: Study Director
affiliation: Oncology Department, RMC
last name: Tal Granot, MA, RN
role: Study Director
affiliation: Davidoff Cancer Center, RMC
last name: Noga Sela, BA, RN
role: Study Chair
affiliation: Oncology, RMC
last name: Sylvia Drier, MA, RN
role: Study Director
affiliation: Davidoff Cancer Center, RMC
last name: Johanna Czamanski-Cohen, PhD
phone: +972532775350
email: joczamanski@gmail.com
facility: 
country: Israel
citation: Uttley L, Stevenson M, Scope A, Rawdin A, Sutton A. The clinical and cost effectiveness of group art therapy for people with non-psychotic mental health disorders: a systematic review and cost-effectiveness analysis. BMC Psychiatry. 2015 Jul 7;15:151. doi: 10.1186/s12888-015-0528-4. Erratum In: BMC Psychiatry. 2015;15:212.
PMID: 26149275
citation: Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
PMID: 24953449
citation: Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
PMID: 16288447
citation: Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.
PMID: 16488349
citation: Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
PMID: 16889324
citation: Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
PMID: 19473224
citation: Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
PMID: 19619378
citation: Boehm K, Cramer H, Staroszynski T, Ostermann T. Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:103297. doi: 10.1155/2014/103297. Epub 2014 Feb 26.
PMID: 24817896
citation: Collie K, Bottorff JL, Long BC. A narrative view of art therapy and art making by women with breast cancer. J Health Psychol. 2006 Sep;11(5):761-75. doi: 10.1177/1359105306066632.
PMID: 16908471
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No