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

NCT03996642 | Completed

• 4 other identifiers: MCC-18-14462HM20014524MCC-18-14462:NCI-2019-03865
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

active; cancer; avatar; life-limiting; palliative care

Outcome Measures

Primary Outcomes (3)

• Portion of successfully completed sessions

  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

  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

  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 Outcomes (3)

• Determine length of time required to set-up the technology

  10 minutes

• Determine the average time per session for each participant

  60 minutes

• Determine the number of intervention sessions needed per patient

  5 minutes

Study Arms (1)

Patients with Active Cancer

OTHER

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

Interventions

Avatar Life Review BEHAVIORAL

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.

Patients with Active Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Massey Cancer Center: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

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MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Egidio Del Fabbro, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a one-group observational design to establish feasibility and acceptability of Avatar therapy intervention in patients with advanced cancer.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 25, 2019
• Study Start: July 19, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 23, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)