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

February 4, 2020 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months
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
15 minutes
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 minutes
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.
60 minutes
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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Massey Cancer Center

Investigators

  • Principal Investigator: Egidio Del Fabbro, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

October 23, 2019

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-18-14462
  • HM20014524 (Other Identifier: IRB)
  • MCC-18-14462: (Other Grant/Funding Number: Massey Cancer Center)
  • NCI-2019-03865 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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