Clinical trial NCT02982421: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Quality of Life: The FACT-B (Hahn et al, 2015)
timeFrame: Change from study start to end of intervention (8 weeks)
Secondary outcomes:
measure: The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)
timeFrame: Change from study start to end of intervention (8 weeks)
measure: Acceptance of Emotion Scale (AE; Weihs et al, 2008)
timeFrame: Change from study start to end of intervention (8 weeks)
measure: Emotional Approach Coping scales (Stanton et al., 2000)
timeFrame: Change from study start to end of intervention (8 weeks)
measure: The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
timeFrame: Change from study start to end of intervention (8 weeks)
measure: Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)
timeFrame: Change from study start to end of intervention (8 weeks)
measure: The Generalized Anxiety Disorder scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
timeFrame: Change from study start to end of intervention (8 weeks)
measure: The Breast Cancer Prevention Trial (BCPT) Symptom Scales (Stanton et al., 2005)
timeFrame: Change from study start to end of intervention (8 weeks)
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical center
Study officials:
affiliation: Oncology Department, RMC
name: Rinat Yerushalmi, MD
role: STUDY_DIRECTOR
affiliation: Davidoff Cancer Center, RMC
name: Tal Granot, MA, RN
role: STUDY_DIRECTOR
affiliation: Oncology, RMC
name: Noga Sela, BA, RN
role: STUDY_CHAIR
affiliation: Davidoff Cancer Center, RMC
name: Sylvia Drier, MA, RN
role: STUDY_DIRECTOR
References:
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.
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: 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: 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: 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: 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: 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: 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: 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.