Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: ImPACT.
- Кому может быть актуально
- Состояния в реестре: Pediatric Cancer, Cognitive Dysfunction. Базовые параметры: 10 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
Обзор
The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.
Подробное описание
Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.
Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.
The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.
Вмешательства
- Поведенческое ImPACT
During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on: 1. Becoming aware of the child's core strengths and difficulties 2. Helping the child to be optimally responsive to the guidance of the parent(s), and 3. Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.
Первичные конечные точки
- Parent-reported neurobehavioral functioning [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported cognitive functioning [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
Вторичные конечные точки (12)
- Parent-reported neurobehavioral functioning [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported cognitive functioning [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported neurobehavioral functioning [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported neurobehavioral functioning [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported cognitive functioning [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported cognitive functioning [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported pediatric quality of life [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported pediatric quality of life [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Child-reported pediatric quality of life [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Child-reported pediatric quality of life [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
- Parent-reported pediatric anxiety and depression [Срок оценки: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)]
- Parent-reported pediatric anxiety and depression [Срок оценки: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)]
Критерии участия
Критерии включения
- Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
- Completed primary treatment at least 6 months ago
- Not terminally ill
- Attend school
- Living with one or more parents who speak Danish and are willing to co-participate
- Screened as having parent-reported cognitive and/or neurobehavioral impairment
Критерии исключения
- Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Aarhus University — Aarhus
Идентификаторы
NCT: NCT05483166 · ImPACT Child