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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220960
Other study ID # 10-049-PSY
Secondary ID
Status Completed
Phase N/A
First received October 9, 2010
Last updated October 24, 2013
Start date August 2010
Est. completion date October 2013

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Cedars Breast Centre\ Royal Victoria Hospital Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Dr. Sarkis Meterissian The Cedars Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

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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