Art Therapy Intervention for Breast Cancer Patients

Sponsor
Dr. Sarkis Meterissian (Other)
Overall Status
Completed
CT.gov ID
NCT01220960
Collaborator
The Cedars Cancer Institute (Other)
64
1
2
38
1.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: art therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being) [8 weeks]

    To investigate whether the implementation of an 8 week art therapy course in post-operative outpatient breast cancer patients can alleviate/improve Emotional distress as assessed by the Hospital Depression and Anxiety Scale (HADS) (please see below for details) Physical symptoms as assessed by the Edmonton Symptom Assessment Scale (ESAS) 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

  1. Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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 Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Sharon Wexler, PhD, Cedars CanSupport
  • Principal Investigator: Monisha Sudarshan, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Study Director: Sarkis Meterissian, PhD, MUHC Cedars Breast Centre

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dr. Sarkis Meterissian, Professor of Surgery and Oncology Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT01220960
Other Study ID Numbers:
  • 10-049-PSY
First Posted:
Oct 14, 2010
Last Update Posted:
Oct 25, 2013
Last Verified:
Oct 1, 2013
Keywords provided by Dr. Sarkis Meterissian, Professor of Surgery and Oncology Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2013