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Идёт набор NCT07089927

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

Без фазы С лечением Malignant Solid Neoplasm Hematopoietic and Lymphatic System Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Art Therapy, Interview, Survey Administration.
Кому может быть актуально
Состояния в реестре: Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm. Базовые параметры: 10 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Feasibility-Enrollment [Срок оценки: Up to 4 months]
  • Feasibility-Completion [Срок оценки: Up to 4 months]
  • Intervention Usability Scale [Срок оценки: Up to 4 months]
  • Acceptability-Exit Interview [Срок оценки: Up to 6 months]
  • Change in Anxiety [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 2 центра
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Rochester — Rochester

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗