Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
Обзор исследования
Статус
Подробное описание
Participants randomized to the intervention arm will complete the computerized working memory training program. This computer-based training program is completed in the home and requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers. This individual will not complete post-intervention assessments to maintain study blind. A home computer with internet connection and speakers is required. A laptop computer and/or wireless internet access will be provided to families whose only obstacle to participation is lack of computer access or internet connectivity in the home setting. Families randomized to the WM intervention will complete a tutorial with study staff that provides instruction in using a computer, the internet and the WM training software.
The objective of this study is to investigate the benefits of this working memory intervention in a sample of childhood cancer survivors and look at brain-based changes that may occur as the result of working memory intervention. To achieve this goal, we plan to study childhood cancer survivors randomly assigned to the working memory intervention or a passive waitlist. Both groups will participate in cognitive testing pre-, post-, and six months post intervention. Intervention participants will also partake in neuroimaging exams before and after the intervention. Findings from this study have direct potential to support a nonpharmaceutical cognitive intervention for cancer survivors that is a safe and effective alternative to stimulant medications with great promise for improving quality of life.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Tennessee
-
Memphis, Tennessee, Соединенные Штаты, 38105
- St. Jude Children's Research Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria for Screening Phase:
- Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL
- Infratentorial tumor location (for the BT cohort)
- Off treatment for at least one year with no evidence of recurrent or progressive disease
- Age 8-16 years inclusive at the time of enrollment
- English as the primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Exclusion Criteria for Screening Phase
- Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols)
- History of CNS injury/disease predating or unrelated to cancer diagnosis
- Documented ADHD predating cancer diagnosis
- Treatment with psychostimulant or psychotropic medication within two weeks of study participation
- Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis)
Inclusion Criteria for Intervention Phase
- Signed screening consents and has undergone screening
- Fully evaluable psychological testing results (including IQ > or = 70)
- Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span < 7 OR at least one standard deviation below IQ score
- Training aide is available to participate in required sessions
- Participant and training aide demonstrate computer proficiency
- Participant has access to or will be provided a laptop or home computer with internet connection and speakers
- Participant willing to participate in required aspects of computerized intervention
- Participant is able to take part in fMRI without sedation
Exclusion Criteria for Intervention Phase
- Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)
- Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Intervention Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention).
|
A computer-based training program will be completed in the home.
This program requires approximately 30 minutes every weekday for five weeks.
The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance.
Exercises train both visuospatial and verbal WM using child-friendly activities.
A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers).
Intervention participants will also partake in neuroimaging exams before and after the intervention
|
|
Другой: Control Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).
|
Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams.
They will complete an immediate and six month post follow-up cognitive assessment.
Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
This study will measure working memory, attention and executive functions
Временное ограничение: Baseline, 10 weeks, and 6 months
|
Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.
|
Baseline, 10 weeks, and 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The study will measure the maintenance of improvements on measures of working memory, attention and executive functions
Временное ограничение: 6 months.
|
The improvements will be evaluated at six months following participation in the computer-based intervention program.
|
6 months.
|
|
This study will examine the neural correlates of working memory before and immediately after intervention
Временное ограничение: Baseline and 10 weeks.
|
This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.
|
Baseline and 10 weeks.
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Heather M Conklin, Ph.D, St. Jude Children's Research Hospital
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- COGTRN
- 120421-RSGPB-11-009-01-CPPB (Другой номер гранта/финансирования: American Cancer Society)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .