- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07660458
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Zhigang Lan, M.D. PhD.
- 전화번호: 18980606446
- 이메일: 158075478@qq.com
연구 장소
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Sichuan
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Chengdu, Sichuan, 중국
- 모병
- West China Hospital of Sichuan University
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연락하다:
- Zhigang Lan, M.D. PhD.
- 전화번호: 18980606446
- 이메일: 158075478@qq.com
-
연락하다:
- 이메일: 158075478@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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해당 없음 - 관찰 연구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Treatment Adherence Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Parenting Stress Index-Short Form (PSI-SF) Total Score
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- WestChinaH-HX-2026-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
수모세포종에 대한 임상 시험
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C17 Council모병풍부한 Neuropil 및 True Rosettes가 있는 배아 종양 | 수모세포종, 소아기 | 다층 로제트가 있는 배아 종양 | 신경 모세포종 | 송과체종 | 횡문근 특징을 가진 CNS 배아 종양 | 수질상피종 | 수모세포종, 그룹 3 | 수모세포종, 그룹 4 | 상의모세포종 | 비정형 기형 횡문근 종양 | CNS 배아 종양 | CNS, Medulloblastoma | CNS 배아 종양, nos캐나다