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NCT Number: NCT07089927

Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial

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.

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Key information

Conditions

Malignant Solid Neoplasm Hematopoietic and Lymphatic System Neoplasm

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Visual or cognitive impairment which may impede completing the art project or the data collection measures
  • Endorsed suicidality (via PHQ-A or otherwise)

Treatment and study plan

Art Therapy

Procedure

Complete virtual art therapy sessions. When complete the participant will receive a 3D printed replica of the avatar.

interview

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility-Enrollment

    Time frame: Up to 4 months

    Assessed via the percentage of eligible participants who enroll in this study.

  2. Feasibility-Completion

    Time frame: Up to 4 months

    Assessed via the percentage of participants who complete at least 75% of the intervention sessions.

  3. 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.

  4. 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.

  5. 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 measement 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.

  6. 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 measement 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.

  7. 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 measement 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.

  8. 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 measement 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Regina Becker

CONTACT

[email protected]

480-342-6079

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

AVATARS: Adolescent and Young Adult Virtual Art Therapy Assisted Re-Integration During Cancer Survivorship

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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