- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220960
Art Therapy Intervention for Breast Cancer Patients
A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
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Montreal, Quebec, Canada, H3A 1A1
- Cedars Breast Centre\ Royal Victoria Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any woman 18-years or older
- Stage I to III breast cancer (first time diagnosis)
- Minimum of 6 weeks Post Operative status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being)
Time Frame: 8 weeks
|
To investigate whether the implementation of an 8 week art therapy course in post-operative outpatient breast cancer patients can alleviate/improve
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis
Time Frame: 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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-049-PSY
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.
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