Breast Cancer Clinical Trial
Official title:
A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
| Verified date | October 2013 |
| Source | McGill University Health Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | October 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | Cedars Breast Centre\ Royal Victoria Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Sarkis Meterissian | The Cedars Cancer Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being) | 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). |
8 weeks | No |
| Secondary | Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis | 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 | No |
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