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Recruiting NCT05907265

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

No phase Interventional Cancer Cognitive Impairment

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: Behavioral: ONCOBrain_ImmersiveVR, Behavioral: Control_Condition.
Who it may be relevant to
Registry conditions: Cancer, Cognitive Impairment. Basic parameters: 18 years — 65 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
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral Behavioral: Control_Condition
    Traditional paper or pdf format multimodal intervention that will combine cognitive, mediation and physical activities.

Primary outcome measures

  • Differences between groups in scores of global cognition [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of selective attention, inhibition, and processing speed [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of Visual scanning and processing speed [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of Executive functioning and cognitive flexibility [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of auditory attention [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of working memory [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of sustained attention and impulsivity [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of processing speed [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of verbal memory and learning [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of phonetic fluency [Time frame: Before the intervention and 12 weeks later]
Secondary outcome measures (11)
  • Differences between groups in scores of anxiety [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of depression [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of Fatigue [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of Quality of Life [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in cancer-related quality of life [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in Functionality [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of Sleep Quality [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of performed physical activity [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of loneliness [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of psychological coping responses for cancer [Time frame: Before the intervention and 12 weeks later]
  • Differences between groups in scores of fear of cancer recurrence [Time frame: Before the intervention and 12 weeks later]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Consorci Sanitari de Terrassa — Terrassa

Identifiers

NCT: NCT05907265 · 01-22-107-107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗