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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Zhigang Lan, M.D. PhD.
- Número de telefone: 18980606446
- E-mail: 158075478@qq.com
Locais de estudo
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Sichuan
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Chengdu, Sichuan, China
- Recrutamento
- West China Hospital of Sichuan University
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Contato:
- Zhigang Lan, M.D. PhD.
- Número de telefone: 18980606446
- E-mail: 158075478@qq.com
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Contato:
- E-mail: 158075478@qq.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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Não aplicável - estudo observacional
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Treatment Adherence Score
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Parenting Stress Index-Short Form (PSI-SF) Total Score
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- WestChinaH-HX-2026-002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
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- SEIVA
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