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

NCT05907265 | Recruiting

• 1 other identifier: 01-22-107-107
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Cognitive Impairment

Outcome Measures

Primary Outcomes (14)

• Differences between groups in scores of global cognition

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of selective attention, inhibition, and processing speed

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of Visual scanning and processing speed

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of Executive functioning and cognitive flexibility

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of auditory attention

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of working memory

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of sustained attention and impulsivity

  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).

  Before the intervention and 12 weeks later

• Differences between groups in scores of processing speed

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of verbal memory and learning

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of phonetic fluency

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of semantic verbal fluency

  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.

  Before the intervention and 12 weeks later

• Differences between groups in scores of memory and everyday forgetfulness

  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.

  Before the intervention and 12 weeks later

• Differences between groups in word knowledge and verbal concept

  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.

  Before the intervention and 12 weeks later

• Differences between groups in self-reported executive functioning

  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.

  Before the intervention and 12 weeks later

Secondary Outcomes (11)

• Differences between groups in scores of anxiety

  Before the intervention and 12 weeks later

• Differences between groups in scores of depression

  Before the intervention and 12 weeks later

• Differences between groups in scores of Fatigue

  Before the intervention and 12 weeks later

• Differences between groups in scores of Quality of Life

  Before the intervention and 12 weeks later

• Differences between groups in cancer-related quality of life

  Before the intervention and 12 weeks later

Study Arms (2)

Immersive Virtual Reality group

EXPERIMENTAL

The intervention will be group-based, with 5 participants per group, and will consist of a total of 24 sessions of 60 minutes. These 24 sessions are organized over 12 weeks, 2 sessions per week. The sessions will consist of a group program of multimodal stimulation using immersive MK360 technology to train cognitive, emotional, and physical areas. Each session will have a different content, although they will follow the following outline: 1. Welcome and awareness of the here and now. 2. Mindfulness techniques 3. Cognitive stimulation 4. Physical activation 5. Feedback and end of session. The visual material used for each session will be specific and adapted to the group.

Behavioral: Behavioral: ONCOBrain_ImmersiveVR

Active Comparator: Active control program

ACTIVE COMPARATOR

In paper or pdf format, patients in the active control group will receive guidelines for physical and cognitive stimulation to do autonomously at home. Patients in the active control group will receive guidelines for cognitive and physical stimulation and meditation exercises in paper or pdf format, to be done independently at home. They will be encouraged to do physical exercises, meditation, and cognitive activities two times a week.

Behavioral: Behavioral: Control_Condition

Interventions

Behavioral: ONCOBrain_ImmersiveVR BEHAVIORAL

A multimodal and digitally-based cognitive training, physical exercise and mindfulness intervention delivered face to face and through 360MK Virtual Reality technology

Immersive Virtual Reality group

Behavioral: Control_Condition BEHAVIORAL

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

Active Comparator: Active control program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, 08227, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Maite Garolera

CONTACT

+34937310007; mgarolera@cst.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST)

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)