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

NCT ID: NCT05907265

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immersive Virtual Reality group

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.

Group Type EXPERIMENTAL

Behavioral: ONCOBrain_ImmersiveVR

Intervention Type BEHAVIORAL

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

Active Comparator: Active control program

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.

Group Type ACTIVE_COMPARATOR

Behavioral: Control_Condition

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Behavioral: Control_Condition

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Maite Garolera

Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Consorci Sanitari de Terrassa

Terrassa, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maite Garolera

Role: CONTACT

+34937310007

Facility Contacts

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Maite Garolera

Role: primary

+34937310007

Other Identifiers

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01-22-107-107

Identifier Type: -

Identifier Source: org_study_id

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