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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02982421
Other study ID # 0304-16-RMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 24, 2016
Last updated December 1, 2016
Start date December 2016
Est. completion date June 2017

Study information

Verified date July 2016
Source Rabin Medical Center
Contact Johanna Czamanski-Cohen, PhD
Phone +972532775350
Email joczamanski@gmail.com
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Group art therapy
Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
Control
Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.

Locations

Country Name City State
Israel Rabin Medical center Petah Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Oster I, Svensk AC, Magnusson E, Thyme KE, Sjõdin M, Aström 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. — View Citation

Svensk AC, Oster I, Thyme KE, Magnusson E, Sjödin M, Eisemann M, Aström 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. — View Citation

Thyme KE, Sundin EC, Wiberg B, Oster I, Aström 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. — View 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. Review. Erratum in: BMC Psychiatry. 2015;15:212. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life: The FACT-B (Hahn et al, 2015) 36 item scale Change from study start to end of intervention (8 weeks) No
Secondary The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990) 20 item scale Change from study start to end of intervention (8 weeks) No
Secondary Acceptance of Emotion Scale (AE; Weihs et al, 2008) 13 item scale Change from study start to end of intervention (8 weeks) No
Secondary Emotional Approach Coping scales (Stanton et al., 2000) 36 item scale Change from study start to end of intervention (8 weeks) No
Secondary The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005). 15 item scale Change from study start to end of intervention (8 weeks) No
Secondary Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997) 20 item scale Change from study start to end of intervention (8 weeks) No
Secondary The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006) 7 item scale Change from study start to end of intervention (8 weeks) No
Secondary The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005) 23 item scale Change from study start to end of intervention (8 weeks) No
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