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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04978 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-012402 | Other Identifier | Mayo Clinic Institutional Review Board | |
| AVATARS | Other Identifier | Mayo Clinic in Arizona |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art Therapy | Procedure | Complete virtual art therapy sessions. When complete the participant will receive a 3D printed replica of the avatar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility-Enrollment | Assessed via the percentage of eligible participants who enroll in this study. | Up to 4 months |
| Feasibility-Completion | Assessed via the percentage of participants who complete at least 75% of the intervention sessions. | 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. | 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. | 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. | 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 measement 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regina Becker | Contact | 480-342-6079 | Becker.regina@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| C. Robert Bennett, PhD, RN | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Interview | Other | Ancillary studies |
|
| Survey Administration | Other | Ancillary studies |
|
| 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 measement 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. | 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 measement 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. | 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 measement at T5 (2 months post session four |
| Mayo Clinic in Rochester | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
|
| ID | Term |
|---|---|
| D001155 | Art Therapy |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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