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Clinical Trials/NCT01220960
NCT01220960CompletedNot Applicable

A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer

Dr. Sarkis Meterissian2 sites in 1 country64 target enrollmentStarted: August 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
2
Primary Endpoint
Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Any woman 18-years or older
  • Stage I to III breast cancer (first time diagnosis)
  • Minimum of 6 weeks Post Operative status

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 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 Outcomes

  • Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis(8 weeks)

Investigators

Sponsor
Dr. Sarkis Meterissian
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Sarkis Meterissian

Professor of Surgery and Oncology Clinic

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Sites (2)

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