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Идёт набор NCT07660458

Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma

— Наблюдательное Medulloblastoma Recurrent Medulloblastoma

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: Not applicable- observational study.
Кому может быть актуально
Состояния в реестре: Medulloblastoma, Recurrent Medulloblastoma. Базовые параметры: 0 лет — 18 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
Китай
Следующий шаг
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Официальное название

Parental Distress as a Predictor of Treatment Adherence in Pediatric Recurrent Medulloblastoma: A Prospective Longitudinal Cohort Study

Обзор

Children with medulloblastoma, an aggressive brain tumor, require prolonged and complex multimodal therapy. Their primary parental caregivers bear the main responsibility for ensuring treatment adherence, yet the psychological toll on these caregivers may undermine their ability to follow prescribed regimens. This study investigates whether multidimensional parental distress predicts overall treatment adherence in this population, and which specific distress domains are most strongly associated with poor adherence. Parental distress-including depression, anxiety, and posttraumatic stress-is common among parents of children with cancer and may interfere with their ability to manage complex treatment regimens. However, no study has specifically examined whether parental distress predicts treatment adherence in children with recurrent medulloblastoma, a devastating brain tumor with a poor prognosis and no standard treatment protocol. This prospective longitudinal cohort study aims to investigate whether parental distress is a significant predictor of treatment adherence in children with recurrent medulloblastoma. A total of 450 parent-child dyads will be enrolled across 4 tertiary pediatric oncology centers. Children must have a confirmed diagnosis of recurrent medulloblastoma and be receiving active treatment. Parents (primary caregivers) will complete validated questionnaires at baseline assessing depression, anxiety, stress, and trauma-related distress using the DASS-21 and IES-R. Treatment adherence will be monitored over a 12-month follow-up period using electronic medication monitoring caps, clinic attendance records, and parent-reported medication logs. The primary outcome is the proportion of prescribed chemotherapy doses taken (treatment adherence rate). Secondary outcomes include trajectories of adherence over time and the relationship between specific dimensions of parental distress (depression, anxiety, stress, posttraumatic stress) and adherence patterns. The study will also examine whether child clinical factors (e.g., molecular subgroup, prior treatment history) and family demographic factors moderate this relationship. Findings from this study may inform the development of targeted psychosocial interventions to support distressed parents and improve treatment adherence-and ultimately clinical outcomes-in this vulnerable pediatric population. Participants can expect to be enrolled in the study for approximately 12 months.

Вмешательства

  • Другое Not applicable- observational study
    Not applicable- observational study

Первичные конечные точки

  • Overall Treatment Adherence Score [Срок оценки: 12 months from enrollment]
Вторичные конечные точки (2)
  • Parenting Stress Index-Short Form (PSI-SF) Total Score [Срок оценки: 12 months from enrollment]
  • DASS-21 Subscale Scores [Срок оценки: 12 months from enrollment]

Критерии участия

Inclusion Criteria(Children):

  • Diagnosis of medulloblastoma with documented recurrence (radiographic or histopathological confirmation)
  • Age ≤ 18 years at enrollment
  • Currently receiving active treatment for recurrent disease
  • Life expectancy ≥ 3 months

Inclusion Criteria (Parents/Caregivers):

  • Primary caregiver responsible for medication administration and treatment coordination
  • Age ≥ 18 years
  • Able to read and understand study materials in \[English\]
  • Willing to complete study assessments

Критерии исключения

  • Child receiving exclusively palliative/hospice care
  • Parent with severe psychiatric illness or cognitive impairment preventing informed consent or questionnaire completion
  • Child enrolled in another interventional trial that would confound adherence measurement

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07660458 · WestChinaH-HX-2026-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗