Art Therapy Intervention for Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
The Cedars Cancer Institute
Information provided by (Responsible Party):
Dr. Sarkis Meterissian, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01220960
First received: October 9, 2010
Last updated: October 24, 2013
Last verified: October 2013
  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:


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.


Enrollment: 64
Study Start Date: August 2010
Study Completion Date: October 2013
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.

  Eligibility

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

Inclusion Criteria:

  1. Any woman 18-years or older
  2. Stage I to III breast cancer (first time diagnosis)
  3. Minimum of 6 weeks Post Operative status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Cedars Breast Centre\ Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Dr. Sarkis Meterissian
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:
No publications provided

Responsible Party: Dr. Sarkis Meterissian, Professor of Surgery and Oncology Clinic, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01220960     History of Changes
Other Study ID Numbers: 10-049-PSY
Study First Received: October 9, 2010
Last Updated: October 24, 2013
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 July 22, 2014