Clinical trial · Observational
Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors
A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Advances in medical care have significantly improved survival among children with cancer. In China, the 5-year survival rate has reached 71.9%. Despite these improvements, many survivors continue to experience multiple co-occurring symptoms, such as fatigue, pain, sleep disturbance, and depression, which may adversely affect their quality of life. These symptoms often occur together as symptom clusters and may reflect shared underlying biological mechanisms. This study aims to characterize symptom clusters among childhood cancer survivors and to explore their potential biological basis. Participants will complete questionnaire assessments at multiple time points to evaluate symptom patterns and changes over time. In addition, stool samples will be collected to analyze gut microbiota composition and metabolite profiles. The study will examine the associations between symptom clusters and gut microbiota-metabolite features. Findings from this study are expected to improve understanding of symptom burden in childhood cancer survivors and to provide evidence for the development of targeted symptom management strategies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Leukemia (Both ALL and AML) | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Childhood Cancer Survivors and Their Primary Caregivers
- description
- This cohort includes children aged 8-18 years diagnosed with cancer (leukemia, lymphoma, CNS tumors, or common solid tumors) who have completed active treatment or are in maintenance/recovery for ≥6 months. Eligible children must have normal cognitive and communication abilities. Primary caregivers are adults aged ≥ 20 years who provide main care and can complete assessments. Exclusion criteria include severe treatment-related complications, cognitive or communication impairments, inability to complete study procedures independently, recent major life events for caregivers, or concurrent interventions affecting outcomes. No interventions are applied; this is an observational study. Data collection includes repeated symptom assessments and stool sample analysis to explore gut microbiota and metabolite associations with symptom clusters.
Primary outcomes (1)
- measure
- Symptom Cluster Severity and Structure in Childhood Cancer Survivors
- timeFrame
- Baseline, 3 months, and 6 months after enrollment
- description
- Symptom clusters will be assessed using validated patient-reported outcome instruments measuring fatigue, pain, sleep disturbance, depression, and related symptoms. Latent growth mixture modeling and network analysis will be used to identify cluster structures, severity levels, and longitudinal trajectories. Higher scores indicate greater symptom burden and more severe clustering patterns.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Children: * Aged 8-18 years; * Clinically and pathologically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, or other common solid tumors); * Currently in the rehabilitation/maintenance phase or completed treatment ≥6 months prior to enrollment; * No cognitive impairment; able to understand, communicate, and complete questionnaires independently; * Written informed consent/assent obtained from participants and their legal guardians. Exclusion Criteria for Children: * Presence of severe treatment-related sequelae (e.g., significant organ dysfunction or neurological impairment) that may interfere with symptom assessment; * Poor compliance or inability to independently complete interviews/questionnaires; * Concurrent participation in other interventional clinical trials that may influence study outcomes; * Planned major surgery or initiation of new chemotherapy/radiotherapy during the study period. Inclusion Criteria for Caregivers: * Primary caregiver of an eligible CCS participant; * Aged ≥20 years; * Able to understand study content and complete questionnaires, with adequate literacy and communication ability; * Written informed consent provided prior to participation. Exclusion Criteria for Caregivers: * Experience of major adverse life events within the past 6 months (e.g., bereavement, divorce) that may affect psychological assessment * Presence of severe cognitive impairment; * Presence of severe aphasia, psychiatric disorders, or other conditions preventing independent completion of assessments.
References
Publications (0)
Data not yet available