MedulloblastomaNCT07660458
Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma
An observational study of Medulloblastoma and Recurrent Medulloblastoma, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Medulloblastoma, Recurrent Medulloblastoma
- What is being tested?
- Not applicable- observational study
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Parent-child dyads where child has recurrent medulloblastoma and is receiving active treatment
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Medulloblastoma, Recurrent Medulloblastoma
- Being tested
- Not applicable- observational study
- Keywords
- Pediatric Brain Tumor；Parental Distress；Treatment Adherence；Psycho-Oncology；Caregiver Stress
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Parent-Child Dyads with Recurrent Medulloblastoma | Children with recurrent medulloblastoma receiving active treatment and their primary caregivers Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Treatment Adherence Score
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.
Measured: 12 months from enrollment
Secondary outcomes (2)
Parenting Stress Index-Short Form (PSI-SF) Total Score
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.
Measured: 12 months from enrollment
DASS-21 Subscale Scores
Depression, Anxiety and Stress Scale-21 scores for each subscale (range 0-21), with higher scores indicating greater symptom severity.
Measured: 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to administrative review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MedulloblastomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shanghai Children's Medical Center, Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660458
- Sponsor's protocol ID
- WestChinaH-HX-2026-002
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request to the corresponding author and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Distress as a Predictor of Treatment Adherence in Pediatric Recurrent Medulloblastoma: A Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT07660458
- Acronym / sponsor ID
- WestChinaH-HX-2026-002
- Conditions
- Medulloblastoma, Recurrent Medulloblastoma
- Keywords
- Pediatric Brain Tumor；Parental Distress；Treatment Adherence；Psycho-Oncology；Caregiver Stress
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment due to administrative review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shanghai Children's Medical Center, Children's Hospital of Chongqing Medical University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent-Child Dyads with Recurrent Medulloblastoma | – | Other: Not applicable- observational studyChildren with recurrent medulloblastoma receiving active treatment and their primary caregivers |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Parent-child dyads where child has recurrent medulloblastoma and is receiving active treatment
Key inclusion criteria (8 listed)
- 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
- Primary caregiver responsible for medication administration and treatment coordination
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Parent-Child Dyads with Recurrent Medulloblastoma |
Primary outcome
Overall Treatment Adherence Score
Time frame: 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.
2 secondary outcomes
Parenting Stress Index-Short Form (PSI-SF) Total Score
Time frame: 12 months from enrollment
DASS-21 Subscale Scores
Time frame: 12 months from enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request to the corresponding author and institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medulloblastoma and Recurrent Medulloblastoma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Treatment Adherence Score (time frame: 12 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.