Clinical trial NCT05907265: Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer
Official title: Study of the Benefits of Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer (OncoBRAIN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Cognitive Impairment
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Differences between groups in scores of global cognition
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of selective attention, inhibition, and processing speed
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of Visual scanning and processing speed
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of Executive functioning and cognitive flexibility
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of auditory attention
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of working memory
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of sustained attention and impulsivity
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of processing speed
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of verbal memory and learning
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of phonetic fluency
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of semantic verbal fluency
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of memory and everyday forgetfulness
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in word knowledge and verbal concept
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in self-reported executive functioning
timeFrame: Before the intervention and 12 weeks later
Secondary outcomes:
measure: Differences between groups in scores of anxiety
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of depression
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of Fatigue
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of Quality of Life
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in cancer-related quality of life
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in Functionality
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of Sleep Quality
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of performed physical activity
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of loneliness
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of psychological coping responses for cancer
timeFrame: Before the intervention and 12 weeks later
measure: Differences between groups in scores of fear of cancer recurrence
timeFrame: Before the intervention and 12 weeks later
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
Study officials:
References: