Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma
Parental Distress as a Predictor of Treatment Adherence in Pediatric Recurrent Medulloblastoma: A Prospective Longitudinal Cohort Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhigang Lan, M.D. PhD.
- Número de teléfono: 18980606446
- Correo electrónico: 158075478@qq.com
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana
- Reclutamiento
- West China Hospital of Sichuan University
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Contacto:
- Zhigang Lan, M.D. PhD.
- Número de teléfono: 18980606446
- Correo electrónico: 158075478@qq.com
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Contacto:
- Correo electrónico: 158075478@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Parent-Child Dyads with Recurrent Medulloblastoma
Children with recurrent medulloblastoma receiving active treatment and their primary caregivers
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No aplicable- estudio observacional
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Treatment Adherence Score
Periodo de tiempo: 12 months from enrollment
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Composite adherence score (range 0-10) based on the 8-item Morisky Medication Adherence Scale (MMAS-8) plus clinic attendance and home-care behavior index.
Higher scores indicate better adherence.
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12 months from enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parenting Stress Index-Short Form (PSI-SF) Total Score
Periodo de tiempo: 12 months from enrollment
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36-item scale assessing parental distress across three subdomains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Range 36-180, higher scores indicate greater stress.
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12 months from enrollment
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DASS-21 Subscale Scores
Periodo de tiempo: 12 months from enrollment
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Depression, Anxiety and Stress Scale-21 scores for each subscale (range 0-21), with higher scores indicating greater symptom severity.
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12 months from enrollment
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WestChinaH-HX-2026-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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