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Brain TumorsNCT02890940

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

A study testing Pet Therapy in people with Brain Tumors and Quality of Life, run by Indiana University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pet Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
Aug 2016to May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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.

Being tested
Pet Therapy
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pet TherapyBehavioural

    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.

Study groups in NCT02890940
Study groupRoleWhat they receive
Pet TherapyExperimentalNot described
Receives: Behavioral: Pet Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediately prior to therapy session to immediately after therapy session

Secondary outcomes (1)

  1. 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.

    Measured: Immediately prior to therapy session to immediately after therapy session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionMay 2020
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02890940
Sponsor's protocol ID
1604467360
Status last verified
Sep 2023
First submitted
1 Sep 2016
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 24963138

  • 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.

    PubMed 20507891

  • 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.

    PubMed 19001097

Questions about this trial

What is this clinical trial studying?

A study testing Pet Therapy in people with Brain Tumors and Quality of Life, run by Indiana University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of facial expression changes with QOL questionnaire responses (time frame: Immediately prior to therapy session to immediately after therapy session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02890940, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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