UnknownNot Applicable

Technological Gaming in Cancer Survivors (WINNERS)

Spain56 participantsStarted 2023-02-23

Plain-language 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).

Who can participate

Age range8 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 preve…

What they're measuring

SDMT Test

Timeframe: Baseline

Change in SDMT Test

Timeframe: At 3 months after recruitment

Change in SDMT Test

Timeframe: At 6 months after recruitment

"DIGITOS" Test

Timeframe: Baseline

Change in "DIGITOS" Test

Timeframe: At 3 months after recruitment

Change in "DIGITOS" Test

Timeframe: At 6 months after recruitment

"TONI-4" test

Timeframe: Baseline

Change in "TONI-4" test

Timeframe: At 3 months after recruitment

Change in "TONI-4" test

Timeframe: At 6 months after recruitment

Trial details

NCT IDNCT06312969

SponsorAntonio Pérez Martínez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

Carlos Gonzalez-Perez, MD

0034917277223 carlos.gonzalez2@salud.madrid.org

View on ClinicalTrials.gov More Survivors of Childhood Cancer trials

Plain-language summary

Who can participate

Age range8 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

SDMT Test

Timeframe: Baseline

Change in SDMT Test

Timeframe: At 3 months after recruitment

Change in SDMT Test

Timeframe: At 6 months after recruitment

"DIGITOS" Test

Timeframe: Baseline

Change in "DIGITOS" Test

Timeframe: At 3 months after recruitment

Change in "DIGITOS" Test

Timeframe: At 6 months after recruitment

"TONI-4" test

Timeframe: Baseline

Change in "TONI-4" test

Timeframe: At 3 months after recruitment

Change in "TONI-4" test

Timeframe: At 6 months after recruitment