- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890940
Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with brain tumors
- Willingness to participate in a brief pet therapy session with a dog
- Willingness to allow photographs, pictures and audio used in an art exhibit
Exclusion Criteria:
- Allergy to dogs
- Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pet Therapy
|
Patients will be asked to complete the standardized QLQ-C30/BN20 questionnaires. Following completion of the questionnaires, a trained pet therapy dog will be brought to the patients for approximately 10 minutes. After approximately 10 minutes, the dog will be removed and the patients will be asked to re-complete the standardized QLQ-C30/BN20 questionnaires. Patients will be photographed and videographed during this time. Finally, patients will be asked to talk about how their perspectives on life have changed with their diagnosis. These responses will be captured for use in the art exhibit created from images collected during the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of facial expression changes with QOL questionnaire responses
Time Frame: Immediately prior to therapy session to immediately after therapy session
|
Will look to see if there is a correlation between facial expression changes in visual portraits with QOL questionnaire responses before and after pet therapy sessions
|
Immediately prior to therapy session to immediately after therapy session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of scores of QOL questionnaires before and after pet therapy
Time Frame: Immediately prior to therapy session to immediately after therapy session
|
Will compare QOL questionnaire scores from before and after pet therapy sessions to see if there is a change after the pet therapy.
|
Immediately prior to therapy session to immediately after therapy session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahua Dey, MD, Indiana University
- Principal Investigator: Stefan Petranek, Indiana University
Publications and helpful links
General Publications
- Variations VII by John Cage (Experiments in Art & Technology), Artpix/Microcinema International, 2008, DVD.
- Jill Fox, Artists-In-Labs: Networking in the Margins (New York: SpringerWien, 2010)
- Karin Lipson, "Islip Exhibition Explores How Science Influences Art," The New York Times, October 22, 2015
- "The Scar Project," accessed January 12, 2016, http://www.thescarproject.org/
- "Ne Serait ce Qu' Une Seconde," The Mimi Foundation, accessed December 27, 2015. https://www.youtube.com/watch?v=GFVMe8w0Tx0.
- Ferry Q, Steinberg J, Webber C, FitzPatrick DR, Ponting CP, Zisserman A, Nellaker C. Diagnostically relevant facial gestalt information from ordinary photos. Elife. 2014 Jun 24;3:e02020. doi: 10.7554/eLife.02020.
- Langner, O., Dotsch, R., Bijlstra, G., Wigboldus, D. H. J., Hawk, S. T., & van Knippenberg, A. (2010). Presentation and validation of the Radboud Faces Database. Cognition and Emotion, 24(8), 1377-1388.
- Taphoorn MJ, Sizoo EM, Bottomley A. Review on quality of life issues in patients with primary brain tumors. Oncologist. 2010;15(6):618-26. doi: 10.1634/theoncologist.2009-0291. Epub 2010 May 27.
- Liu R, Page M, Solheim K, Fox S, Chang SM. Quality of life in adults with brain tumors: current knowledge and future directions. Neuro Oncol. 2009 Jun;11(3):330-9. doi: 10.1215/15228517-2008-093. Epub 2008 Nov 10.
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1604467360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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