NCT02890940

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

September 1, 2016

Last Update Submit

September 25, 2023

Conditions

Outcome Measures

Primary Outcomes (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

    Immediately prior to therapy session to immediately after therapy session

Secondary Outcomes (1)

  • Comparison of scores of QOL questionnaires before and after pet therapy

    Immediately prior to therapy session to immediately after therapy session

Study Arms (1)

Pet Therapy

EXPERIMENTAL
Behavioral: Pet Therapy

Interventions

Pet TherapyBEHAVIORAL

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.

Pet Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Variations VII by John Cage (Experiments in Art & Technology), Artpix/Microcinema International, 2008, DVD.

    BACKGROUND
  • Jill Fox, Artists-In-Labs: Networking in the Margins (New York: SpringerWien, 2010)

    BACKGROUND
  • Karin Lipson, "Islip Exhibition Explores How Science Influences Art," The New York Times, October 22, 2015

    BACKGROUND
  • "The Scar Project," accessed January 12, 2016, http://www.thescarproject.org/

    BACKGROUND
  • "Ne Serait ce Qu' Une Seconde," The Mimi Foundation, accessed December 27, 2015. https://www.youtube.com/watch?v=GFVMe8w0Tx0.

    BACKGROUND
  • 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.

    PMID: 24963138BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20507891BACKGROUND
  • 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.

    PMID: 19001097BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mahua Dey, MD

    Indiana University

    PRINCIPAL INVESTIGATOR
  • Stefan Petranek

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Photography and Intermedia

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share