Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer

Официальное название

Study of the Benefits of Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer (OncoBRAIN)

Обзор

OncoBRAIN aims to assess the effect of an innovative immersive virtual reality-based (IVR) intervention that includes cognitive, physical activity and mindfulness exercises in people diagnosed with cancer and Chemotherapy-Related Cognitive Deficits (CRCD). The main objective of OncoBRAIN is to determine the benefits of RVI intervention on the cognitive, and emotional state and quality of life of people with cancer and CRQD. We hypothesize that in OncoBRAIN we will find improvements in people with cancer and CRCD who have received IVR stimulation compared to the control group with cancer and CRCD who have not received IVR stimulation. People in the experimental group will perform better than patients in the control group in cognition (episodic memory, executive function, attention, and information processing speed), show better emotional well-being and perceive a better quality of life at the end of the intervention.

Вмешательства

• Поведенческое Behavioral: ONCOBrain_ImmersiveVR
  A multimodal and digitally-based cognitive training, physical exercise and mindfulness intervention delivered face to face and through 360MK Virtual Reality technology
• Поведенческое Behavioral: Control_Condition
  Traditional paper or pdf format multimodal intervention that will combine cognitive, mediation and physical activities.

Первичные конечные точки

• Differences between groups in scores of global cognition [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of selective attention, inhibition, and processing speed [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of Visual scanning and processing speed [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of Executive functioning and cognitive flexibility [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of auditory attention [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of working memory [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of sustained attention and impulsivity [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of processing speed [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of verbal memory and learning [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of phonetic fluency [Срок оценки: Before the intervention and 12 weeks later]

Вторичные конечные точки (11)

• Differences between groups in scores of anxiety [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of depression [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of Fatigue [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of Quality of Life [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in cancer-related quality of life [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in Functionality [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of Sleep Quality [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of performed physical activity [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of loneliness [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of psychological coping responses for cancer [Срок оценки: Before the intervention and 12 weeks later]
• Differences between groups in scores of fear of cancer recurrence [Срок оценки: Before the intervention and 12 weeks later]

Критерии участия

Критерии включения

A. Over 18 years of age and under 65 years of age B. Diagnosis of cancer C. At least 4 weeks since the last chemotherapy treatment session D. Presence of cognitive complaints after chemotherapy treatment E. Level of primary education to be able to perform the cognitive tests. F. Consent to participate in the study

Критерии исключения

A. Established diagnosis prior to cancer diagnosis of psychiatric, neurological, neurodevelopmental or systemic disorder causing cognitive deficits.

B. Motor or sensory impairments that preclude completion of the program. C. Undergoing chemotherapy treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Consorci Sanitari de Terrassa — Terrassa

Идентификаторы

NCT: NCT05907265 · 01-22-107-107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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