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The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors

This study is not yet open for participant recruitment.
Verified July 2016 by Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02982421
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: Group art therapy Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Group Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors Receiving Hormonal Therapy

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Quality of Life: The FACT-B (Hahn et al, 2015) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    36 item scale


Secondary Outcome Measures:
  • The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    20 item scale

  • Acceptance of Emotion Scale (AE; Weihs et al, 2008) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    13 item scale

  • Emotional Approach Coping scales (Stanton et al., 2000) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    36 item scale

  • The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005). [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    15 item scale

  • Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    20 item scale

  • The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    7 item scale

  • The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005) [ Time Frame: Change from study start to end of intervention (8 weeks) ]
    23 item scale


Estimated Enrollment: 20
Study Start Date: December 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Research
Group Art Therapy
Behavioral: Group art therapy
Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
Sham Comparator: Control
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
Behavioral: Control
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult women (over age 18), breast cancer survivors without evidence of active illness, hebrew speaking and receiving preventative hormonal therapy for at least 6 months (steady state), receiving care at the survivor's clinic of Davidoff Medical Center

Exclusion Criteria:

A psychiatric diagnosis requiring medication, functional difficulties that affect the ability to handle art supplies, non-hebrew speaking, unwilling to answer the research questionnaires

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982421


Contacts
Contact: Johanna Czamanski-Cohen, PhD +972532775350 joczamanski@gmail.com

Locations
Israel
Rabin Medical center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Rinat Yerushalmi, MD Oncology Department, RMC
Study Director: Tal Granot, MA, RN Davidoff Cancer Center, RMC
Study Chair: Noga Sela, BA, RN Oncology, RMC
Study Director: Sylvia Drier, MA, RN Davidoff Cancer Center, RMC
  More Information

Publications:

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02982421     History of Changes
Other Study ID Numbers: 0304-16-RMC
First Submitted: July 24, 2016
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases