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Recruiting NCT07089927

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

No phase Interventional Malignant Solid Neoplasm Hematopoietic and Lymphatic System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Art Therapy, Interview, Survey Administration.
Who it may be relevant to
Registry conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm. Basic parameters: 10 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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:

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.

Interventions

  • Procedure Art Therapy
    Complete virtual art therapy sessions. When complete the participant will receive a 3D printed replica of the avatar.
  • Other Interview
    Ancillary studies
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Feasibility-Enrollment [Time frame: Up to 4 months]
  • Feasibility-Completion [Time frame: Up to 4 months]
  • Intervention Usability Scale [Time frame: Up to 4 months]
  • Acceptability-Exit Interview [Time frame: Up to 6 months]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07089927 · AVATARS · NCI-2025-04978 · 24-012402 · AVATARS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗