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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996642
• Other study ID #: MCC-18-14462
• Secondary ID: HM20014524MCC-18
• Status: Completed
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: October 23, 2019

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 23, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Massey Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Determine length of time required to set-up the technology	length of setup time as determined when first entering the outpatient room to the arrival of the patient	10 minutes
Secondary	Determine the average time per session for each participant	Length of session as determined by the start of participant's arrival to their departure.	60 minutes
Secondary	Determine the number of intervention sessions needed per patient	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