Cognitive Training Through Technological Gaming To Ameliorate Cognitive Effects Related To Childhood Cancer Treatment (WINNERS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in "TONI-4" test
研究概览
简要总结
HYPOTHESIS
- Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
- 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.
- Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
- 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.
- The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
- 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
- Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
- Statistically significant changes in neuroimaging tests.
- 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).
详细描述
BACKGROUND AND RATIONALE Several authors have described specific cognitive damage following cancer treatments (often chemotherapy and radiotherapy), which has been termed "chemo-brain". This condition produces alterations in different neurocognitive fields such as memory, learning, concentration, reasoning, executive functions, attention and visuospatial skills.
In this research project the investigator team propose an intervention aimed at one of the most limiting adverse effects of cancer and its treatment such as neurocognitive deficits through technological game platforms and brain training used in a directed, controlled and supervised manner.
HYPOTHESIS
- Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
- 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.
- Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
- 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.
- The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Waiting group (no training)
Patients in waiting group will not receive treatment whilst the 3 month period.
Intervention group with video game-based training
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.
干预措施: Video game based training (Behavioral)
结局指标
主要结局
Change in "TONI-4" test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)
"ROCF" test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)
Change in "BRIEF" survey
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)
"TONI-4" test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (non-verbal intelligence)
Change in "STROOP" test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)
Change in "TAVECI" test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (verbal learning)
SDMT Test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.
Change in SDMT Test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level by means of neuropsychological tests.
Change in "DIGITOS" Test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (processing speed)
"DIGITOS" Test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (processing speed)
Change in "CPT3"
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)
Statistically significant changes in neuroimaging tests
时间窗: At 6 months after recruitment
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).
Change in "ROCF" test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (visuo-constructional ability and non-verbal memory)
"CPT3"
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (performance in attention tasks)
"BRIEF" survey
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (assessment of executive functions by parents)
"BASC" survey
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)
"TFV" test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)
Change in "TFV" test
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (verbal fluency)
"STROOP" test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (selective attention and inhibitory control)
"TAVECI" test
时间窗: Baseline
To evaluate the benefits of treatment at the neurocognitive level (verbal learning)
Change in "BASC" survey
时间窗: At 6 months after recruitment
To evaluate the benefits of treatment at the neurocognitive level (Behavior Assesment)
Immune and inflammatory biomarkers
时间窗: Baseline
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)
Statistically significant changes in immune and inflammatory biomarkers
时间窗: At 6 months after recruitment
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)
次要结局
- Prevalence(Baseline)
- Perception of the family measured by satisfaction survey(Through study completion, 6 months)
研究者
Antonio Pérez Martínez
Head of the Hemato-Oncology department
Instituto de Investigación Hospital Universitario La Paz