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Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer

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ClinicalTrials.gov Identifier: NCT03996642
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Massey Cancer Center
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE July 19, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Portion of successfully completed sessions [ Time Frame: 2 months ]
    The total number of sessions completed in compliance with the required protocol divided by the total number of sessions attempted
  • Patient's perceived benefits of intervention [ Time Frame: 15 minutes ]
    The research coordinator will conduct an open-ended interview to assess patients' perception of intervention components and identify possible factors influencing feasibility. Questions will address feasibility of setup time, study procedure, and level of comfort
  • The ability to recruit patients to participate in the Avatar Therapy intervention [ Time Frame: 2 months ]
    Feasibility of recruitment efforts will be determined by the proportion of patients that are enrolled divided by the number of patients contacted and approached to participate.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Determine length of time required to set-up the technology [ Time Frame: 10 minutes ]
    length of setup time as determined when first entering the outpatient room to the arrival of the patient
  • Determine the average time per session for each participant [ Time Frame: 60 minutes ]
    Length of session as determined by the start of participant's arrival to their departure.
  • Determine the number of intervention sessions needed per patient [ Time Frame: 5 minutes ]
    Participants will complete a 3 item brief survey administered by the research coordinator at the end of each session to determine if patients would benefit from another avatar session. Each item is rated on a five-point Likert scale from "1= Not at all to "5= A lot/Extremely" with higher scores indicating greater patient satisfaction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer
Official Title  ICMJE Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer
Brief Summary The objective of the study is to determine the feasibility and acceptability of an integrated art and technology, storytelling, life review platform for patients with active cancer. The VoicingHan project is an avatar storytelling platform designed for patients with advanced cancer receiving palliative care at Virginia Commonwealth University's Massey Cancer Center. VoicingHan supports terminally ill patients by using oral storytelling as an artistic medium to facilitate patients' interactive performances. Movement-based, creative expression has been shown to reduce stress and depression. By projecting movement-based actions onto an avatar, this can serve as a tool to express emotional distress, address satisfaction with care, and view cancer in a different light.
Detailed Description

Life reviews have been used in palliative care to help individuals integrate memories into a meaningful whole, providing a balanced view of the past, present and future. Life review is also an evaluative process, enabling participants to examine how memories contribute to the meaning of their life.

VoicingHan, the software program that will be used in this study, provides an illusion that the Avatar is speaking, allowing users to observe their stories in real time, potentially encouraging deeper reflection and memory retrieval. The technology uses motion capture (MoCap) to translate human movement into a digital platform. MoCap offers several advantages: lightweight, sensitive to minute movement, and user-friendly.

Patients will select avatars from different age groups during their sessions, allowing them to retrieve specific, positive memories of different lifetime periods and facilitating a more candid autobiographical memory. Creative expression may serve as a vehicle for patients with a life limiting illness in finding purpose and creating a sense of meaning. The integration of art and technology into a storytelling, life-review platform through means of engaging the physical, psychological, and spiritual domains will support patients to contemplate their own mortality.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This study will use a one-group observational design to establish feasibility and acceptability of Avatar therapy intervention in patients with advanced cancer.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Avatar Life Review
VoicingHan will screen-capture patient's storytelling performances as video files. Immediately before the first intervention, patients will complete an array of self-reported questionnaires to assess physical, spiritual, and psychological well-being and elicit relevant demographic and medical information. The assessments include the ESAS, FACIT-Sp subscale, and EORTC PAL 15. Subsequent administration of these questionnaires spaced 2-4 weeks apart will occur before each avatar session (pre-intervention). This will determine if intensity of the patient's symptoms have changed over the course of the intervention. Following completion of the Avatar session, a member of the research team will conduct a semi-structured, open-ended interview to assess patients' perception of intervention components and identify possible factors influencing intervention feasibility and any technical barriers.
Study Arms  ICMJE Patients with Active Cancer
Eligible participants will undergo an unknown number of Avatar-life review sessions depending on acceptability of the intervention to subjects and the capacity of the team to provide the intervention.
Intervention: Behavioral: Avatar Life Review
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
12
Actual Study Completion Date  ICMJE October 23, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be 18 years of age or older
  • Patient participants must have metastatic or locally recurrent cancer
  • Participants must be able to understand English
  • Participants must be ambulatory
  • Ability and willingness to sign a written informed consent document

Exclusion Criteria:

  • Participants who cannot understand written or spoken English
  • Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996642
Other Study ID Numbers  ICMJE MCC-18-14462
HM20014524 ( Other Identifier: IRB )
MCC-18-14462: ( Other Grant/Funding Number: Massey Cancer Center )
NCI-2019-03865 ( Other Identifier: NCI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Massey Cancer Center
Investigators  ICMJE
Principal Investigator: Egidio Del Fabbro, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP