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

C

Consorci Sanitari de Terrassa

Status

Enrolling

Conditions

Cognitive Impairment
Cancer

Treatments

Behavioral: Behavioral: ONCOBrain_ImmersiveVR
Behavioral: Behavioral: Control_Condition

Study type

Interventional

Funder types

Other

Identifiers

NCT05907265
01-22-107-107

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Immersive Virtual Reality group
Experimental group
Description:
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.
Treatment:
Behavioral: Behavioral: ONCOBrain_ImmersiveVR
Active Comparator: Active control program
Active Comparator group
Description:
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.
Treatment:
Behavioral: Behavioral: Control_Condition

Trial contacts and locations

1

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Central trial contact

Maite Garolera

Data sourced from clinicaltrials.gov

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