Medulloblastoma, Recurrent Medulloblastoma
Conditions
Keywords
Pediatric Brain Tumor；Parental Distress；Treatment Adherence；Psycho-Oncology；Caregiver Stress
Brief summary
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.
Interventions
OTHERNot applicable- observational study
Not applicable- observational study
Sponsors
West China Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shanghai Children's Medical Center
Children's Hospital of Chongqing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Adherence Score | 12 months from enrollment | GMAS（General Medication Adherence Scale），The GMAS is an 11-item self-assessment tool. Each item has 4 response options (e.g., Always, Mostly, Sometimes, Never), which are scored as 0, 1, 2, or 3 points respectively. The total score ranges from 0 to 33, with higher scores indicating better adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Stress Index-Short Form (PSI-SF) Total Score | 12 months from enrollment | 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. |
| DASS-21 Subscale Scores | 12 months from enrollment | Depression, Anxiety and Stress Scale-21 scores for each subscale (range 0-21), with higher scores indicating greater symptom severity. |
Countries
China
Outcome results
None listed