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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Differences between groups in scores of global cognition — Before the intervention and 12 weeks later
  Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
• Differences between groups in scores of selective attention, inhibition, and processing speed — Before the intervention and 12 weeks later
  Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
• Differences between groups in scores of Visual scanning and processing speed — Before the intervention and 12 weeks later
  Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.
• Differences between groups in scores of Executive functioning and cognitive flexibility — Before the intervention and 12 weeks later
  Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.
• Differences between groups in scores of auditory attention — Before the intervention and 12 weeks later
  Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
• Differences between groups in scores of working memory — Before the intervention and 12 weeks later
  Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
• Differences between groups in scores of sustained attention and impulsivity — Before the intervention and 12 weeks later
  Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).
• Differences between groups in scores of processing speed — Before the intervention and 12 weeks later
  The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.
• Differences between groups in scores of verbal memory and learning — Before the intervention and 12 weeks later
  Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.
• Differences between groups in scores of phonetic fluency — Before the intervention and 12 weeks later
  Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.
• Differences between groups in scores of semantic verbal fluency — Before the intervention and 12 weeks later
  Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.
• Differences between groups in scores of memory and everyday forgetfulness — Before the intervention and 12 weeks later
  Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \<8 represent an optimal memory function. Lower scores indicate better outcomes.
• Differences between groups in word knowledge and verbal concept — Before the intervention and 12 weeks later
  Word Knowledge and verbal concept are measures with the Vocabulary subtest of The Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV). It requires the participant to try to define up to 30 words, with higher scores indicating better outcomes.
• Differences between groups in self-reported executive functioning — Before the intervention and 12 weeks later
  Self-reported executive functioning is measured with The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A), which has 75 items within nine non-overlapping theoretically and empirically derived clinical scales, including Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Higher scores indicate wors outcomes.

Trial sites (1)

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