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Trial Title:
Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer
NCT ID:
NCT05907265
Condition:
Cancer
Cognitive Impairment
Conditions: Official terms:
Cognitive Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral: ONCOBrain_ImmersiveVR
Description:
A multimodal and digitally-based cognitive training, physical exercise and mindfulness
intervention delivered face to face and through 360MK Virtual Reality technology
Arm group label:
Immersive Virtual Reality group
Intervention type:
Behavioral
Intervention name:
Behavioral: Control_Condition
Description:
Traditional paper or pdf format multimodal intervention that will combine cognitive,
mediation and physical activities.
Arm group label:
Active Comparator: Active control program
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Consorci Sanitari de Terrassa
Address:
City:
Terrassa
Zip:
08227
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maite Garolera
Phone:
+34937310007
Email:
mgarolera@cst.cat
Start date:
May 1, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Consorci Sanitari de Terrassa
Agency class:
Other
Source:
Consorci Sanitari de Terrassa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907265
