Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer
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| ClinicalTrials.gov Identifier: NCT03996642 |
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Recruitment Status :
Completed
First Posted : June 25, 2019
Last Update Posted : February 6, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Behavioral: Avatar Life Review | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| 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 |
| Official Title: | Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer |
| Actual Study Start Date : | July 19, 2019 |
| Actual Primary Completion Date : | August 30, 2019 |
| Actual Study Completion Date : | October 23, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996642
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Egidio Del Fabbro, MD | Virginia Commonwealth University |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT03996642 |
| 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 ) |
| First Posted: | June 25, 2019 Key Record Dates |
| Last Update Posted: | February 6, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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active cancer avatar life-limiting palliative care |