Technological Gaming in Cancer Survivors (WINNERS)

Summary

HYPOTHESIS

1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.

VARIABLES

1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
2. Statistically significant changes in neuroimaging tests.
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.

STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.

POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).

Conditions

• Survivors of Childhood Cancer

Interventions

BEHAVIORAL

Video game based training

Type of intervention: Cognitive training through 3 types of video games: * "Serious games" or "brain-training games". * Exer-gaming * Skill-training games Method of administration: The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern: * "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week. * "Exer-gaming": sessions of 15-20 minutes 2 days a week. * "Skill-training games": sessions of 15-20 minutes 2 days a week.

Sponsors & Collaborators

• Hospital Ruber Internacional

  collaborator OTHER

• Universidad Rey Juan Carlos

  collaborator OTHER

• Antonio Pérez Martínez

  lead OTHER

Principal Investigators

• Antonio Pérez-Martínez, PhD · Hospital la Paz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-23

Primary Completion

2024-09-30

Completion

2025-02-28

Countries

• Spain

Study Locations