NCT02982421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 5, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

July 24, 2016

Last Update Submit

December 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Life: The FACT-B (Hahn et al, 2015)

    36 item scale

    Change from study start to end of intervention (8 weeks)

Secondary Outcomes (7)

  • The levels of Emotional Awareness Scale (LEAS; Lane et al, 1990)

    Change from study start to end of intervention (8 weeks)

  • Acceptance of Emotion Scale (AE; Weihs et al, 2008)

    Change from study start to end of intervention (8 weeks)

  • Emotional Approach Coping scales (Stanton et al., 2000)

    Change from study start to end of intervention (8 weeks)

  • The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).

    Change from study start to end of intervention (8 weeks)

  • Center for Epidemiologic Studies Depression Scale (CES-D) (Cohen, 1997)

    Change from study start to end of intervention (8 weeks)

  • +2 more secondary outcomes

Study Arms (2)

Research

EXPERIMENTAL

Group Art Therapy

Behavioral: Group art therapy

Control

SHAM COMPARATOR

Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.

Behavioral: Control

Interventions

Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.

Research
ControlBEHAVIORAL

Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical center

Petah Tikva, Israel, 49100, Israel

Location

Related Publications (9)

  • 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.

    PMID: 26149275BACKGROUND
  • 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: 24953449BACKGROUND
  • 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: 16288447BACKGROUND
  • 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: 16488349BACKGROUND
  • 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: 16889324BACKGROUND
  • 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: 19473224BACKGROUND
  • 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: 19619378BACKGROUND
  • 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: 24817896BACKGROUND
  • 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: 16908471BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rinat Yerushalmi, MD

    Oncology Department, RMC

    STUDY DIRECTOR
  • Tal Granot, MA, RN

    Davidoff Cancer Center, RMC

    STUDY DIRECTOR
  • Noga Sela, BA, RN

    Oncology, RMC

    STUDY CHAIR
  • Sylvia Drier, MA, RN

    Davidoff Cancer Center, RMC

    STUDY DIRECTOR

Central Study Contacts

Johanna Czamanski-Cohen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2016

First Posted

December 5, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

December 5, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations