Art Therapy Intervention for Breast Cancer Patients - Full Text View

Purpose

As studies continue to debate the effects of quality of life on survival, increased attention is being focused on investigating complementary alternative therapies to boost overall total health in cancer patients . Art therapy is an interesting growing field, which has shown promise to positively influence quality of life in the pediatric and adult oncology population alike. As there is a paucity of well controlled complete studies in this field, the investigators propose to study the impact of art therapy sessions in women with breast cancer with quantitative and qualitative analysis of emotional health and physical symptoms.

The results of the investigators study will have widespread applicability to oncology programs that wish to offer/implement such sessions to their palliative and non-palliative outpatients in an effort to address the important concept of whole person care.

Condition	Intervention
Breast Cancer	Other: art therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To investigate whether the implementation of an 8 week art therapy course in post-operative outpatient breast cancer patients can alleviate/improve
1. Emotional distress as assessed by the Hospital Depression and Anxiety Scale (HADS) (please see below for details)
2. Physical symptoms as assessed by the Edmonton Symptom Assessment Scale (ESAS)
3. Meaning making as assessed by The Generalized Self-Efficacy Scale (GSES) and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12).

Secondary Outcome Measures:

Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To investigate qualitatively how group art therapy can address the psychosocial impacts of breast cancer, including the challenges of finding and creating meaning following a recent diagnosis of breast cancer.

Estimated Enrollment:	64
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Art Therapy intervention group For participants who will be part of the art therapy intervention, the art therapy group will be a closed group for eight women with breast cancer who are in treatment and recently have had surgery. The group will meet once a week for two hours over a period of 8 weeks, and will focus on exploring the expressive capabilities of art making in a supportive group. This group will be held in the conference room at the Cedars Breast Clinic. Each week will revolve around a theme that pertains to the experience of women living with breast cancer, and will be guided by the women's needs in the group. A broad range of art materials will be made available and various art techniques explored. No art experience is necessary. The intervention group will also need to fill out simple questionnaires before the art therapy groups starts and after the group finishes	Other: art therapy Art therapy sessions, 2 hours in duration, 1 session/week, 8 continuous weeks of sessions. Each group will be limited to eight women as space is limited.
No Intervention: Control Group The group not assigned to the intervention group will be asked to fill out questionnaires at two separate times (before and after the intervention group is run). The Control group will be offered the opportunity to join an open art therapy group upon completing the questionnaires.

Arms

Assigned Interventions

Experimental: Art Therapy intervention group

For participants who will be part of the art therapy intervention, the art therapy group will be a closed group for eight women with breast cancer who are in treatment and recently have had surgery. The group will meet once a week for two hours over a period of 8 weeks, and will focus on exploring the expressive capabilities of art making in a supportive group. This group will be held in the conference room at the Cedars Breast Clinic. Each week will revolve around a theme that pertains to the experience of women living with breast cancer, and will be guided by the women's needs in the group. A broad range of art materials will be made available and various art techniques explored. No art experience is necessary. The intervention group will also need to fill out simple questionnaires before the art therapy groups starts and after the group finishes

Other: art therapy

Art therapy sessions, 2 hours in duration, 1 session/week, 8 continuous weeks of sessions. Each group will be limited to eight women as space is limited.

No Intervention: Control Group

The group not assigned to the intervention group will be asked to fill out questionnaires at two separate times (before and after the intervention group is run). The Control group will be offered the opportunity to join an open art therapy group upon completing the questionnaires.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any woman 18-years or older
Stage I to III breast cancer (first time diagnosis)
Minimum of 6 weeks Post Operative status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220960

Contacts

Contact: Sarkis Meterissian, Dr.	514-934-1934 ext 36631	sarkis.meterissian@muhc.mcgill.ca
Contact: Katherine L Laux, M.A. Art Therapy	514-934-1934 ext 35315	artcanheal@gmail.com

Locations

Canada, Quebec
Cedars Breast Centre\ Royal Victoria Hospital	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Sarkis Meterissian, PhD 514-934-1934 ext 36631 sarkis.meterissian@muhc.mcgill.ca
Contact: Katherine L Laux, MA Art Therapy 514-934-1934 ext 35315 artcanheal@gmail.com
Principal Investigator: Sarkis Meterissian, PhD
Sub-Investigator: Katherine L Laux, MA Art Therapy

Sponsors and Collaborators

McGill University Health Center

The Cedars Cancer Institute

Investigators

Principal Investigator:	Katherine L Laux, MA Art Therapy	Cedars CanSupport
Principal Investigator:	Virginia Lee, PhD	McGill University Health Center
Principal Investigator:	Sharon Wexler, PhD	Cedars CanSupport
Principal Investigator:	Monisha Sudarshan, MD	McGill University Health Center
Study Director:	Sarkis Meterissian, PhD	MUHC Cedars Breast Centre

More Information

Additional Information:

Art Therapy, a kind of complementary therapy for cancer patients This link exits the ClinicalTrials.gov site

Relieving Pain with Art Therapy for Cancer Patients This link exits the ClinicalTrials.gov site

Evaluating Art Therapy for breast cancer patients This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Sarkis Meterissian; Dept: General Surgery, MUHC appointment: Director - Cedars Breast Centre, McGill appointment: Dean Postgraduate Medical Education
ClinicalTrials.gov Identifier:	NCT01220960 History of Changes
Other Study ID Numbers:	10-049-PSY
Study First Received:	October 9, 2010
Last Updated:	August 3, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

art therapy
breast cancer
women
young women
older women

quality of life
meaning making
support group
art making
art symbols

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013