Technological Gaming in Cancer Survivors (WINNERS)

NCT06312969 | Recruiting

• 1 other identifier: 2022.301
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS

1. 1.Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. 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. 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. 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. 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. 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.
7. 7.Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
8. 8.Statistically significant changes in neuroimaging tests.
9. 9.Statistically significant changes in immune and inflammatory biomarkers before and after treatment.

Conditions

Survivors of Childhood Cancer

Keywords

Cancer Survivors; Survivors of Childhood Cancer; Chemotherapy-related Cognitive Impairment; Functional Magnetic Resonance Imaging (fMRI); Video Games; Exergaming

Outcome Measures

Primary Outcomes (35)

• SDMT Test

  To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

  Baseline

• Change in SDMT Test

  To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

  At 3 months after recruitment

• Change in SDMT Test

  To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.

  At 6 months after recruitment

• "DIGITOS" Test

  To evaluate the benefits of treatment at the neurocognitive level (processing speed)

  Baseline

• Change in "DIGITOS" Test

  To evaluate the benefits of treatment at the neurocognitive level (processing speed)

  At 3 months after recruitment

• Change in "DIGITOS" Test

  To evaluate the benefits of treatment at the neurocognitive level (processing speed)

  At 6 months after recruitment

• "TONI-4" test

  To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

  Baseline

• Change in "TONI-4" test

  To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

  At 3 months after recruitment

• Change in "TONI-4" test

  To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)

  At 6 months after recruitment

• "ROCF" test

  To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

  Baseline

• Change in "ROCF" test

  To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

  At 3 months after recruitment

• Change in "ROCF" test

  To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)

  At 6 months after recruitment

• "TFV" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

  Baseline

• Change in "TFV" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

  At 3 months after recruitment

• Change in "TFV" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)

  At 6 months after recruitment

• "STROOP" test

  To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

  Baseline

• Change in "STROOP" test

  To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

  At 3 months after recruitment

• Change in "STROOP" test

  To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)

  At 6 months after recruitment

• "TAVECI" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

  Baseline

• Change in "TAVECI" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

  At 3 months after recruitment

• Change in "TAVECI" test

  To evaluate the benefits of treatment at the neurocognitive level (verbal learning)

  At 6 months after recruitment

• "CPT3"

  To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

  Baseline

• Change in "CPT3"

  To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

  At 3 months after recruitment

• Change in "CPT3"

  To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)

  At 6 months after recruitment

• "BRIEF" survey

  To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

  Baseline

• Change in "BRIEF" survey

  To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

  At 3 months after recruitment

• Change in "BRIEF" survey

  To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)

  At 6 months after recruitment

• "BASC" survey

  To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

  Baseline

• Change in "BASC" survey

  To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

  At 3 months after recruitment

• Change in "BASC" survey

  To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)

  At 6 months after recruitment

• Statistically significant changes in neuroimaging tests

  Changes in structural imaging (white matter volume, gray matter volume and total intracranial volume, brain lobe volume and voxel-based morphometry), in diffusion (diffusion maps and structural connectivity) and in functional imaging (resting-state fMRI and task-based fMRI).

  At 3 months after recruitment

• Statistically significant changes in neuroimaging tests

  Changes in structural imaging (white matter volume, gray matter volume and total intracranial volume, brain lobe volume and voxel-based morphometry), in diffusion (diffusion maps and structural connectivity) and in functional imaging (resting-state fMRI and task-based fMRI).

  At 6 months after recruitment

• Immune and inflammatory biomarkers

  Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

  Baseline

• Statistically significant changes in immune and inflammatory biomarkers

  Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

  At 3 months after recruitment

• Statistically significant changes in immune and inflammatory biomarkers

  Study of lymphocyte populations by parametric flow cytometry (T lymphocytes, B lymphocytes, NK lymphocytes, NK T lymphocytes) and inflammatory cytokines by LUMINEX (IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17a, IL-1R antagonist)

  At 6 months after recruitment

Secondary Outcomes (2)

• Prevalence

  Baseline

• Perception of the family measured by satisfaction survey

  Through study completion, 6 months

Study Arms (2)

Intervention group with video game-based training

EXPERIMENTAL

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.

Behavioral: Video game based training

Waiting group (no training)

NO INTERVENTION

Patients in waiting group will not receive treatment whilst the 3 month period.

Interventions

Video game based training BEHAVIORAL

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.

Intervention group with video game-based training

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 8 and 17 years of age at the time of recruitment.
• Have completed treatment between 1 and 6 years prior to recruitment.
• Have had one of the following diagnoses:
• Patients with CNS disease (posterior fossa tumors and supratentorial gliomas smaller than 1 cm affecting associative areas).
• Patients with hematologic malignancies (leukemia or lymphoma).
• Patients with solid tumors.
• Patients with non-malignant hematological diseases and indication for allogeneic hematopoietic progenitor transplantation.
• Having received at least one of the following treatments:
• Central nervous system surgery.
• Central nervous system radiotherapy.
• Intrathecal/intraventricular chemotherapy.
• Neurotoxic systemic chemotherapy.
• Hematopoietic stem cell transplantation.
• Informed consent signed by parent/guardian.

You may not qualify if:

• Active oncologic disease or relapse of active oncologic disease.
• Prior neurological or psychiatric pathology that may preclude trial or treatment evaluations:
• Psychological or neurocognitive illness or sequelae that preclude neuropsychological assessment or are expected to significantly artifact MRI results (examples: significant decrease in visual acuity, CNS surgical scar that artifacts imaging results, severe cognitive delay that precludes testing, etc.).
• Psychological or neurocognitive illnesses or sequelae that prevent or contraindicate the use of video games (epilepsy that prevents the use of screens, significant decrease in visual acuity, etc.).
• Mild or self-limiting neurological or psychiatric pathology that does not interfere with trial diagnosis and treatment (headache, epilepsy in remission with effective treatment, mild cognitive delay, etc.) will be allowed.
• Current or recent (less than 1 year) use of other cognitive stimulation or brain training that may interfere with study results.
• Refusal to abstain from the use of the study treatment games in case of being assigned to group B (control group).
• Medical treatment that may significantly interfere with neuropsychological, imaging or biomarker assessments.

Sponsors & Collaborators

• Antonio Pérez Martínez: lead
• Hospital Ruber Internacional: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Hospital La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (13)

• Alonso Puig M, Alonso-Prieto M, Miro J, Torres-Luna R, Plaza Lopez de Sabando D, Reinoso-Barbero F. The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology. J Med Internet Res. 2020 Mar 30;22(3):e16013. doi: 10.2196/16013.

  PMID: 32224482 BACKGROUND

• Argyriou AA, Assimakopoulos K, Iconomou G, Giannakopoulou F, Kalofonos HP. Either called "chemobrain" or "chemofog," the long-term chemotherapy-induced cognitive decline in cancer survivors is real. J Pain Symptom Manage. 2011 Jan;41(1):126-39. doi: 10.1016/j.jpainsymman.2010.04.021. Epub 2010 Sep 15.

  PMID: 20832978 BACKGROUND

• Semendric I, Pollock D, Haller OJ, George RP, Collins-Praino LE, Whittaker AL. Impact of "chemobrain" in childhood cancer survivors on social, academic, and daily living skills: a qualitative systematic review protocol. JBI Evid Synth. 2022 Jan 1;20(1):222-228. doi: 10.11124/JBIES-21-00115.

  PMID: 34341312 BACKGROUND

• Dovis S, Van der Oord S, Wiers RW, Prins PJ. Improving executive functioning in children with ADHD: training multiple executive functions within the context of a computer game. a randomized double-blind placebo controlled trial. PLoS One. 2015 Apr 6;10(4):e0121651. doi: 10.1371/journal.pone.0121651. eCollection 2015.

  PMID: 25844638 BACKGROUND

• Gerbie MV. Management of the adolescent girl exposed in utero to DES. Pediatr Ann. 1981 Dec;10(12):23-6.

  PMID: 7335401 BACKGROUND

• Conklin HM, Ogg RJ, Ashford JM, Scoggins MA, Zou P, Clark KN, Martin-Elbahesh K, Hardy KK, Merchant TE, Jeha S, Huang L, Zhang H. Computerized Cognitive Training for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2015 Nov 20;33(33):3894-902. doi: 10.1200/JCO.2015.61.6672. Epub 2015 Oct 12.

  PMID: 26460306 BACKGROUND

• Conklin HM, Ashford JM, Clark KN, Martin-Elbahesh K, Hardy KK, Merchant TE, Ogg RJ, Jeha S, Huang L, Zhang H. Long-Term Efficacy of Computerized Cognitive Training Among Survivors of Childhood Cancer: A Single-Blind Randomized Controlled Trial. J Pediatr Psychol. 2017 Mar 1;42(2):220-231. doi: 10.1093/jpepsy/jsw057.

  PMID: 27342301 BACKGROUND

• Benzing V, Eggenberger N, Spitzhuttl J, Siegwart V, Pastore-Wapp M, Kiefer C, Slavova N, Grotzer M, Heinks T, Schmidt M, Conzelmann A, Steinlin M, Everts R, Leibundgut K. The Brainfit study: efficacy of cognitive training and exergaming in pediatric cancer survivors - a randomized controlled trial. BMC Cancer. 2018 Jan 3;18(1):18. doi: 10.1186/s12885-017-3933-x.

  PMID: 29298678 BACKGROUND

• da Silva Alves R, Abdalla DR, Iunes DH, Mariano KOP, Borges JBC, Murta EFC, Michelin MA, Carvalho LC. Influence of an Exergaming Training Program on Reducing the Expression of IL-10 and TGF-beta in Cancer Patients. Games Health J. 2020 Dec;9(6):446-452. doi: 10.1089/g4h.2020.0022. Epub 2020 Jun 4.

  PMID: 32498637 BACKGROUND

• Spitzhuttl JS, Kronbichler M, Kronbichler L, Benzing V, Siegwart V, Pastore-Wapp M, Kiefer C, Slavova N, Grotzer M, Roebers CM, Steinlin M, Leibundgut K, Everts R. Impact of non-CNS childhood cancer on resting-state connectivity and its association with cognition. Brain Behav. 2021 Jan;11(1):e01931. doi: 10.1002/brb3.1931. Epub 2020 Nov 18.

  PMID: 33205895 BACKGROUND

• Lee H, Voss MW, Prakash RS, Boot WR, Vo LT, Basak C, Vanpatter M, Gratton G, Fabiani M, Kramer AF. Videogame training strategy-induced change in brain function during a complex visuomotor task. Behav Brain Res. 2012 Jul 1;232(2):348-57. doi: 10.1016/j.bbr.2012.03.043. Epub 2012 Apr 6.

  PMID: 22504276 BACKGROUND

• Richlan F, Schubert J, Mayer R, Hutzler F, Kronbichler M. Action video gaming and the brain: fMRI effects without behavioral effects in visual and verbal cognitive tasks. Brain Behav. 2017 Dec 16;8(1):e00877. doi: 10.1002/brb3.877. eCollection 2018 Jan.

  PMID: 29568680 BACKGROUND

• Gonzalez-Perez C, Fernandez-Jimenez E, Moran E, Melero H, Malpica N, Alvarez-Linera J, Alonso Puig M, Plaza D, Perez-Martinez A. Study protocol for a randomized controlled clinical trial of a multifaceted cognitive training program using video games in childhood cancer survivors. PLoS One. 2025 Sep 2;20(9):e0314118. doi: 10.1371/journal.pone.0314118. eCollection 2025.

  PMID: 40892751 DERIVED

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Antonio Pérez-Martínez, PhD

  Hospital la Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Gonzalez-Perez, MD

CONTACT

0034917277223; carlos.gonzalez2@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Hemato-Oncology department

Model Details: Randomized versus control group clinical trial.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: March 15, 2024
• Study Start: February 23, 2023
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting right after publication, for at least 1 year
• Access Criteria: Sharing by personal contact

Locations

ES (1)