CancerNCT03996642
Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer
A study testing Avatar Life Review in people with Cancer, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Avatar Life Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Avatar Life Review
- Keywords
- active, cancer, avatar, life-limiting, palliative care
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar Life ReviewBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Avatar Life Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 2 months
Secondary outcomes (3)
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
Measured: 10 minutes
Determine the average time per session for each participant
Length of session as determined by the start of participant's arrival to their departure.
Measured: 60 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start19 Jul 2019
- Primary completion30 Aug 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Massey Cancer Center
- Responsible party
- Sponsor
- Investigators
- Egidio Del Fabbro, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996642
- Sponsor's protocol ID
- MCC-18-14462
- Other IDs
- HM20014524, MCC-18-14462:, NCI-2019-03865
- Status last verified
- Feb 2020
- First submitted
- 11 Jun 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coelho A, Parola V, Cardoso D, Bravo ME, Apostolo J. Use of non-pharmacological interventions for comforting patients in palliative care: a scoping review. JBI Database System Rev Implement Rep. 2017 Jul;15(7):1867-1904. doi: 10.11124/JBISRIR-2016-003204.
PubMed 28708751Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
PubMed 11180574Lopez G, Garcia MK, Liu W, Spano M, Underwood S, Dibaj SS, Li Y, Moguel R, Williams J, Bruera E, Cohen L. Outpatient acupuncture effects on patient self-reported symptoms in oncology care: a retrospective analysis. J Cancer. 2018 Sep 8;9(19):3613-3619. doi: 10.7150/jca.26527. eCollection 2018.
PubMed 30310519Del Fabbro E, Dalal S, Bruera E. Symptom control in palliative care--Part III: dyspnea and delirium. J Palliat Med. 2006 Apr;9(2):422-36. doi: 10.1089/jpm.2006.9.422. No abstract available.
PubMed 16629572Singer AE, Goebel JR, Kim YS, Dy SM, Ahluwalia SC, Clifford M, Dzeng E, O'Hanlon CE, Motala A, Walling AM, Goldberg J, Meeker D, Ochotorena C, Shanman R, Cui M, Lorenz KA. Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review. J Palliat Med. 2016 Sep;19(9):995-1008. doi: 10.1089/jpm.2015.0367. Epub 2016 Aug 17.
PubMed 27533892Holland J, Poppito S, Nelson C, Weiss T, Greenstein M, Martin A, Thirakul P, Roth A. Reappraisal in the eighth life cycle stage: a theoretical psychoeducational intervention in elderly patients with cancer. Palliat Support Care. 2009 Sep;7(3):271-9. doi: 10.1017/S1478951509990198.
PubMed 19788768Ryu S, Imaging K, Commonwealth V, Society K. Avatar life-review : Virtual bodies in a dramatic paradox. 2017;7(2):5-8. doi:10.1386/vcr.7.2.121
World Health Organization. National Cancer Control Programmes. Natl cancer Control Program Policies Manag Guid. 2002:180. http://www.hdnet.org.
Rhondali W, Lasserre E, Filbet M. Art therapy among palliative care inpatients with advanced cancer. Palliat Med. 2013 Jun;27(6):571-2. doi: 10.1177/0269216312471413. No abstract available.
PubMed 23685771Wood MJ, Molassiotis A, Payne S. What research evidence is there for the use of art therapy in the management of symptoms in adults with cancer? A systematic review. Psychooncology. 2011 Feb;20(2):135-45. doi: 10.1002/pon.1722.
PubMed 20878827Haber D. Life review: implementation, theory, research, and therapy. Int J Aging Hum Dev. 2006;63(2):153-71. doi: 10.2190/DA9G-RHK5-N9JP-T6CC.
PubMed 17137032van der Spek N, Vos J, van Uden-Kraan CF, Breitbart W, Cuijpers P, Holtmaat K, Witte BI, Tollenaar RAEM, Verdonck-de Leeuw IM. Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. Psychol Med. 2017 Aug;47(11):1990-2001. doi: 10.1017/S0033291717000447. Epub 2017 Apr 4.
PubMed 28374663Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6.
PubMed 21741309Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, Olden M, Pessin H, Lichtenthal W, Sjoberg D, Cassileth BR. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer. J Clin Oncol. 2012 Apr 20;30(12):1304-9. doi: 10.1200/JCO.2011.36.2517. Epub 2012 Feb 27.
PubMed 22370330Kleijn G, Lissenberg-Witte BI, Bohlmeijer ET, Steunenberg B, Knipscheer-Kuijpers K, Willemsen V, Becker A, Smit EF, Eeltink CM, Bruynzeel AME, van der Vorst M, de Bree R, Leemans CR, van den Brekel MWM, Cuijpers P, Verdonck-de Leeuw IM. The efficacy of Life Review Therapy combined with Memory Specificity Training (LRT-MST) targeting cancer patients in palliative care: A randomized controlled trial. PLoS One. 2018 May 15;13(5):e0197277. doi: 10.1371/journal.pone.0197277. eCollection 2018.
PubMed 29763431
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer
- ClinicalTrials.gov ID
- NCT03996642
- Acronym / sponsor ID
- MCC-18-14462
- Conditions
- Cancer
- Keywords
- active, cancer, avatar, life-limiting, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Massey Cancer Center
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with Active Cancer | Other | Behavioral: Avatar Life ReviewEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar Life ReviewVoicingHan 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. | Behavioural | Patients with Active Cancer |
Primary outcome
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.
3 secondary outcomes
Determine length of time required to set-up the technology
Time frame: 10 minutes
Determine the average time per session for each participant
Time frame: 60 minutes
Determine the number of intervention sessions needed per patient
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 28708751Coelho A, Parola V, Cardoso D, Bravo ME, Apostolo J. Use of non-pharmacological interventions for comforting patients in palliative care: a scoping review. JBI Database System Rev Implement Rep. 2017 Jul;15(7):1867-1904. doi: 10.11124/JBISRIR-2016-003204.
- Background: PubMed 11180574Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
- Background: PubMed 30310519Lopez G, Garcia MK, Liu W, Spano M, Underwood S, Dibaj SS, Li Y, Moguel R, Williams J, Bruera E, Cohen L. Outpatient acupuncture effects on patient self-reported symptoms in oncology care: a retrospective analysis. J Cancer. 2018 Sep 8;9(19):3613-3619. doi: 10.7150/jca.26527. eCollection 2018.
- Background: PubMed 16629572Del Fabbro E, Dalal S, Bruera E. Symptom control in palliative care--Part III: dyspnea and delirium. J Palliat Med. 2006 Apr;9(2):422-36. doi: 10.1089/jpm.2006.9.422. No abstract available.
- Background: PubMed 27533892Singer AE, Goebel JR, Kim YS, Dy SM, Ahluwalia SC, Clifford M, Dzeng E, O'Hanlon CE, Motala A, Walling AM, Goldberg J, Meeker D, Ochotorena C, Shanman R, Cui M, Lorenz KA. Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review. J Palliat Med. 2016 Sep;19(9):995-1008. doi: 10.1089/jpm.2015.0367. Epub 2016 Aug 17.
- Background: PubMed 19788768Holland J, Poppito S, Nelson C, Weiss T, Greenstein M, Martin A, Thirakul P, Roth A. Reappraisal in the eighth life cycle stage: a theoretical psychoeducational intervention in elderly patients with cancer. Palliat Support Care. 2009 Sep;7(3):271-9. doi: 10.1017/S1478951509990198.
- BackgroundRyu S, Imaging K, Commonwealth V, Society K. Avatar life-review : Virtual bodies in a dramatic paradox. 2017;7(2):5-8. doi:10.1386/vcr.7.2.121
- BackgroundWorld Health Organization. National Cancer Control Programmes. Natl cancer Control Program Policies Manag Guid. 2002:180. http://www.hdnet.org.
- Background: PubMed 23685771Rhondali W, Lasserre E, Filbet M. Art therapy among palliative care inpatients with advanced cancer. Palliat Med. 2013 Jun;27(6):571-2. doi: 10.1177/0269216312471413. No abstract available.
- Background: PubMed 20878827Wood MJ, Molassiotis A, Payne S. What research evidence is there for the use of art therapy in the management of symptoms in adults with cancer? A systematic review. Psychooncology. 2011 Feb;20(2):135-45. doi: 10.1002/pon.1722.
- Background: PubMed 17137032Haber D. Life review: implementation, theory, research, and therapy. Int J Aging Hum Dev. 2006;63(2):153-71. doi: 10.2190/DA9G-RHK5-N9JP-T6CC.
- Background: PubMed 28374663van der Spek N, Vos J, van Uden-Kraan CF, Breitbart W, Cuijpers P, Holtmaat K, Witte BI, Tollenaar RAEM, Verdonck-de Leeuw IM. Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. Psychol Med. 2017 Aug;47(11):1990-2001. doi: 10.1017/S0033291717000447. Epub 2017 Apr 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egidio Del Fabbro, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar Life Review in people with Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portion of successfully completed sessions (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996642, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.