Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma

June 16, 2026 updated by: Zhigang Lan, West China Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhigang Lan, M.D. PhD.
  • Phone Number: 18980606446
  • Email: 158075478@qq.com

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parent-child dyads where child has recurrent medulloblastoma and is receiving active treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parent-Child Dyads with Recurrent Medulloblastoma
Children with recurrent medulloblastoma receiving active treatment and their primary caregivers
Other: Not applicable- observational study
Not applicable- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Treatment Adherence Score
Time Frame: 12 months from enrollment
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.
12 months from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Stress Index-Short Form (PSI-SF) Total Score
Time Frame: 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.
12 months from enrollment
DASS-21 Subscale Scores
Time Frame: 12 months from enrollment
Depression, Anxiety and Stress Scale-21 scores for each subscale (range 0-21), with higher scores indicating greater symptom severity.
12 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Shanghai Children's Medical Center
Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-HX-2026-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be available upon reasonable request to the corresponding author and institutional approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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