Malignant Solid NeoplasmNCT07089927
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
A study testing Art Therapy, Interview and Survey Administration in people with Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial summary
This clinical trial tests the feasibility, usability and acceptability of a virtual art therapy assisted re-integration (AVATARS) intervention to improve biopsychosocial outcomes, such as anxiety, depression, resilience, emotional regulation, stress, and cognition, among adolescent and young adult (AYA) cancer… Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Art Therapy, Interview and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2025to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- If young adult- aged 18-25 years of age at the time of enrollment and able to provide informed consent, if adolescent- aged 10-17 years at the time of enrollment and able to provide
- Mild or greater depression [Patient Health Questionnaire (PHQ-A) score > 5]
- Received a cancer diagnosis during the past year, or completed cancer treatment within the past five years (extended survivorship)
- Have access to an electronic device which supports virtual videoconferencing (e.g., personal device or public library access)
- Able to read and write in English
Who cannot join
- Visual or cognitive impairment which may impede completing the art project or the data collection measures
- Endorsed suicidality (via PHQ-A or otherwise)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: AVATARS: Adolescent and Young Adult Virtual Art Therapy Assisted Re-Integration During Cancer Survivorship
This clinical trial tests the feasibility, usability and acceptability of a virtual art therapy assisted re-integration (AVATARS) intervention to improve biopsychosocial outcomes, such as anxiety, depression, resilience, emotional regulation, stress, and cognition, among adolescent and young adult (AYA) cancer survivors. AYA cancer survivors (especially those treated at adult cancer centers) historically experience worse psychosocial outcomes and lack age appropriate psychosocial support compared to older adult cancer survivors. Creative art therapy accesses the limbic system to provide a corrective emotional experience in response to trauma and can help patients visually express depression, anxiety, and existential fears, process traumatic events, and regain agency and control. The AVATARS intervention may be a feasible, useable and acceptable way to improve biopsychosocial outcomes among AYA cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate the AVATARS intervention's feasibility, usability, and acceptability among a sample of AYA cancer survivors.
II. Investigate the preliminary efficacy of the AVATARS intervention on biopsychosocial outcomes (i.e. anxiety, depression, resilience, emotional regulation, stress, and cognition) in AYA cancer survivors.
OUTLINE:
Patients complete virtual art therapy sessions, over 60 minutes, every 1-2 weeks, for 4 sessions. Patients then receive a 3D printed replica of their avatar.
After completion of study treatment, patients are followed up at 1 and 2 months.
- Being tested
- Art Therapy, Interview, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyProcedure or surgery
Complete virtual art therapy sessions. When complete the participant will receive a 3D printed replica of the avatar.
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Virtual art therapy) | Experimental | Patients complete virtual art therapy sessions, over 60 minutes, every 1-2 weeks, for 4 sessions. Patients then receive a 3D printed replica of their avatar. Receives: Procedure: Art Therapy; Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-Enrollment
Assessed via the percentage of eligible participants who enroll in this study.
Measured: Up to 4 months
Feasibility-Completion
Assessed via the percentage of participants who complete at least 75% of the intervention sessions.
Measured: Up to 4 months
Intervention Usability Scale
Assessed by the Intervention Usability Scale. It is a 10-item questionnaire with questions answered on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Higher scores indicate greater usability.
Measured: Up to 4 months
Acceptability-Exit Interview
Participants will be invited to provide feedback about their experience during brief (e.g., 20-30 minute) scripted open-ended question exit interviews. Participants perspectives about the intervention, administration format, and schedule will be used to refine the intervention.
Measured: Up to 6 months
Change in Anxiety
Assessed via State-Trait Anxiety Inventory. This is a 20-item questionnaire related to the current anxiety. Questions are answered on a scale of 1 to 4 where 1 = none at all, 2= a little, 3 = somewhat and 4 = very much so. Higher scores indicate greater feelings of anxiety.
Measured: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Change in Depression
Assessed via Patient Health Questionnaire for Adolescents (PHG-A). This is a 13-item questionnaire related to feelings of depression. Questions 1-9 relate to the last two weeks and are answered on a scale of 0 to 3 where 0=Not at all, 1=Several days, 2=More than half of the days and 3=Nearly every day. Lower scores indicate lesser feelings of depression. Two questions relate to feelings of depression over the past year, and two questions relate to suicidal thoughts.
Measured: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Change in Resilience
Assessed via Connor Davidson Resilience Scale 10 (CD-RISC-10), a 10-item questionnaire related to resilience over the past month. Questions are answered on a scale of 0 to 4, where 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time. Higher scores indicate greater resilience.
Measured: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Change in Emotional regulation
Assessed via Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire related to difficulties in emotional regulation. Questions area answered on a 5-point scale (almost never to almost always). A higher score indicates greater difficulties in emotional regulation.
Measured: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start2 Jul 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. Robert Bennett, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089927
- Sponsor's protocol ID
- AVATARS
- Other IDs
- NCI-2025-04978, 24-012402, AVATARS
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVATARS: Adolescent and Young Adult Virtual Art Therapy Assisted Re-Integration During Cancer Survivorship
- ClinicalTrials.gov ID
- NCT07089927
- Acronym / sponsor ID
- AVATARS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
This clinical trial tests the feasibility, usability and acceptability of a virtual art therapy assisted re-integration (AVATARS) intervention to improve biopsychosocial outcomes, such as anxiety, depression, resilience, emotional regulation, stress, and cognition, among adolescent and young adult (AYA) cancer survivors. AYA cancer survivors (especially those treated at adult cancer centers) historically experience worse psychosocial outcomes and lack age appropriate psychosocial support compared to older adult cancer survivors. Creative art therapy accesses the limbic system to provide a corrective emotional experience in response to trauma and can help patients visually express depression, anxiety, and existential fears, process traumatic events, and regain agency and control. The AVATARS intervention may be a feasible, useable and acceptable way to improve biopsychosocial outcomes among AYA cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- Investigate the AVATARS intervention's feasibility, usability, and acceptability among a sample of AYA cancer survivors.
II. Investigate the preliminary efficacy of the AVATARS intervention on biopsychosocial outcomes (i.e. anxiety, depression, resilience, emotional regulation, stress, and cognition) in AYA cancer survivors.
OUTLINE:
Patients complete virtual art therapy sessions, over 60 minutes, every 1-2 weeks, for 4 sessions. Patients then receive a 3D printed replica of their avatar.
After completion of study treatment, patients are followed up at 1 and 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Virtual art therapy) | Experimental | Procedure: Art Therapy, Other: Interview, Other: Survey AdministrationPatients complete virtual art therapy sessions, over 60 minutes, every 1-2 weeks, for 4 sessions. Patients then receive a 3D printed replica of their avatar. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- If young adult- aged 18-25 years of age at the time of enrollment and able to provide informed consent, if adolescent- aged 10-17 years at the time of enrollment and able to provide
- Mild or greater depression [Patient Health Questionnaire (PHQ-A) score > 5]
- Received a cancer diagnosis during the past year, or completed cancer treatment within the past five years (extended survivorship)
- Have access to an electronic device which supports virtual videoconferencing (e.g., personal device or public library access)
- Able to read and write in English
Key exclusion criteria (2 listed)
- Visual or cognitive impairment which may impede completing the art project or the data collection measures
- Endorsed suicidality (via PHQ-A or otherwise)
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 |
|---|---|---|
| Art TherapyComplete virtual art therapy sessions. When complete the participant will receive a 3D printed replica of the avatar. | Procedure or surgery | Supportive care (Virtual art therapy) |
| InterviewAncillary studies | Other | Supportive care (Virtual art therapy) |
| Survey AdministrationAncillary studies | Other | Supportive care (Virtual art therapy) |
Primary outcome
Feasibility-Enrollment
Time frame: Up to 4 months
Assessed via the percentage of eligible participants who enroll in this study.
Feasibility-Completion
Time frame: Up to 4 months
Assessed via the percentage of participants who complete at least 75% of the intervention sessions.
Intervention Usability Scale
Time frame: Up to 4 months
Assessed by the Intervention Usability Scale. It is a 10-item questionnaire with questions answered on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Higher scores indicate greater usability.
Acceptability-Exit Interview
Time frame: Up to 6 months
Participants will be invited to provide feedback about their experience during brief (e.g., 20-30 minute) scripted open-ended question exit interviews. Participants perspectives about the intervention, administration format, and schedule will be used to refine the intervention.
Change in Anxiety
Time frame: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Assessed via State-Trait Anxiety Inventory. This is a 20-item questionnaire related to the current anxiety. Questions are answered on a scale of 1 to 4 where 1 = none at all, 2= a little, 3 = somewhat and 4 = very much so. Higher scores indicate greater feelings of anxiety.
Change in Depression
Time frame: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Assessed via Patient Health Questionnaire for Adolescents (PHG-A). This is a 13-item questionnaire related to feelings of depression. Questions 1-9 relate to the last two weeks and are answered on a scale of 0 to 3 where 0=Not at all, 1=Several days, 2=More than half of the days and 3=Nearly every day. Lower scores indicate lesser feelings of depression. Two questions relate to feelings of depression over the past year, and two questions relate to suicidal thoughts.
Change in Resilience
Time frame: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Assessed via Connor Davidson Resilience Scale 10 (CD-RISC-10), a 10-item questionnaire related to resilience over the past month. Questions are answered on a scale of 0 to 4, where 0=not true at all, 1=rarely true, 2=sometimes true, 3=often true and 4=true nearly all the time. Higher scores indicate greater resilience.
Change in Emotional regulation
Time frame: T1 (at baseline within 48 hours of recruitment), T2 (within 72 hours post session two, and T3 (within 72 hours post session four), T4 (1 month post session four), and an optional measurement at T5 (2 months post session four)
Assessed via Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire related to difficulties in emotional regulation. Questions area answered on a 5-point scale (almost never to almost always). A higher score indicates greater difficulties in emotional regulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
C. Robert Bennett, PhD, RN principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy, Interview and Survey Administration in people with Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic at 2 sites 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility-Enrollment (time frame: Up to 4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.