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Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients

Primary Purpose

Brain Tumors, Quality of Life, Animal Assisted Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pet Therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pet Therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Correlation of facial expression changes with QOL questionnaire responses
    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

    Secondary Outcome Measures

    Comparison of scores of QOL questionnaires before and after pet therapy
    Will compare QOL questionnaire scores from before and after pet therapy sessions to see if there is a change after the pet therapy.

    Full Information

    First Posted
    September 1, 2016
    Last Updated
    September 25, 2023
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02890940
    Brief Title
    Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients
    Official Title
    Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    May 2020 (Actual)
    Study Completion Date
    May 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this study is to explore whether facial expression changes in visual portraits correlate with Quality of Life (QOL) questionnaire responses before and after pet therapy sessions and to compare scores of QOL questionnaires before and after pet therapy.
    Detailed Description
    Through this pilot study, the investigators propose to create new intersections between video art and clinical care by photographing and videotaping patients with brain tumors before, during and after pet therapy sessions. This exploratory scholarship has two equally compelling goals. First, the artistic component of the project aims to create compelling slow motion video portraits of patients' willing to share their experiences of what it is like to confront such a grave illness. The goal is to put a human face on disease and share the endurance of the human spirit through art. Second, the scientific component will assess the potential of using facial video portraits as a novel and innovative way to measure Quality of Life (QOL) in lieu of questionnaires in brain tumor patients. In addition, the project will evaluate the effects of pet therapy on the QOL of these patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Tumors, Quality of Life, Animal Assisted Therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pet Therapy
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pet Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Correlation of facial expression changes with QOL questionnaire responses
    Description
    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
    Time Frame
    Immediately prior to therapy session to immediately after therapy session
    Secondary Outcome Measure Information:
    Title
    Comparison of scores of QOL questionnaires before and after pet therapy
    Description
    Will compare QOL questionnaire scores from before and after pet therapy sessions to see if there is a change after the pet therapy.
    Time Frame
    Immediately prior to therapy session to immediately after therapy session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahua Dey, MD
    Organizational Affiliation
    Indiana University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Stefan Petranek
    Organizational Affiliation
    Indiana University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Variations VII by John Cage (Experiments in Art & Technology), Artpix/Microcinema International, 2008, DVD.
    Results Reference
    background
    Citation
    Jill Fox, Artists-In-Labs: Networking in the Margins (New York: SpringerWien, 2010)
    Results Reference
    background
    Citation
    Karin Lipson, "Islip Exhibition Explores How Science Influences Art," The New York Times, October 22, 2015
    Results Reference
    background
    Citation
    "The Scar Project," accessed January 12, 2016, http://www.thescarproject.org/
    Results Reference
    background
    Citation
    "Ne Serait ce Qu' Une Seconde," The Mimi Foundation, accessed December 27, 2015. https://www.youtube.com/watch?v=GFVMe8w0Tx0.
    Results Reference
    background
    PubMed Identifier
    24963138
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20507891
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19001097
    Citation
    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.
    Results Reference
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    Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients

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