Back to resultsThe Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Group art therapy
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility 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
Sites / Locations
- Rabin Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Research
Control
Arm Description
Group Art Therapy
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
Outcomes
Primary Outcome Measures
Quality of Life: The FACT-B (Hahn et al, 2015)
36 item scale
Secondary Outcome Measures
The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
20 item scale
Acceptance of Emotion Scale (AE; Weihs et al, 2008)
13 item scale
Emotional Approach Coping scales (Stanton et al., 2000)
36 item scale
The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
15 item scale
Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
20 item scale
The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
7 item scale
The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
23 item scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02982421
Brief Title
The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors
Official Title
The Effect of Group Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors Receiving Hormonal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Research
Arm Type
Experimental
Arm Description
Group Art Therapy
Arm Title
Control
Arm Type
Sham Comparator
Arm 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(s)
Group art therapy
Intervention Description
Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
Primary Outcome Measure Information:
Title
Quality of Life: The FACT-B (Hahn et al, 2015)
Description
36 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Secondary Outcome Measure Information:
Title
The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
Description
20 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
Acceptance of Emotion Scale (AE; Weihs et al, 2008)
Description
13 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
Emotional Approach Coping scales (Stanton et al., 2000)
Description
36 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
Description
15 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
Description
20 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
Description
7 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
Title
The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
Description
23 item scale
Time Frame
Change from study start to end of intervention (8 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Czamanski-Cohen, PhD
Phone
+972532775350
Email
joczamanski@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinat Yerushalmi, MD
Organizational Affiliation
Oncology Department, RMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tal Granot, MA, RN
Organizational Affiliation
Davidoff Cancer Center, RMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noga Sela, BA, RN
Organizational Affiliation
Oncology, RMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sylvia Drier, MA, RN
Organizational Affiliation
Davidoff Cancer Center, RMC
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26149275
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.
Results Reference
background
PubMed Identifier
24953449
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.
Results Reference
background
PubMed Identifier
16288447
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.
Results Reference
background
PubMed Identifier
16488349
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.
Results Reference
background
PubMed Identifier
16889324
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.
Results Reference
background
PubMed Identifier
19473224
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.
Results Reference
background
PubMed Identifier
19619378
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.
Results Reference
background
PubMed Identifier
24817896
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.
Results Reference
background
PubMed Identifier
16908471
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.
Results Reference
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The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors
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