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

December 1, 2016 updated by: Rabin Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from study start to end of intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from study start to end of intervention (8 weeks)
Acceptance of Emotion Scale (AE; Weihs et al, 2008)
Time Frame: Change from study start to end of intervention (8 weeks)
13 item scale
Change from study start to end of intervention (8 weeks)
Emotional Approach Coping scales (Stanton et al., 2000)
Time Frame: Change from study start to end of intervention (8 weeks)
36 item scale
Change from study start to end of intervention (8 weeks)
The Mindful Attention Awareness Scale (MAAS)(Carlson & Brown, 2005).
Time Frame: Change from study start to end of intervention (8 weeks)
15 item scale
Change from study start to end of intervention (8 weeks)
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
Change from study start to end of intervention (8 weeks)
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
Change from study start to end of intervention (8 weeks)
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
Change from study start to end of intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

July 24, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (ESTIMATE)

December 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304-16-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe