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.
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;
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.
This study will recruit childhood cancer survivors (CCS) aged 8-18 years and their primary caregivers. Eligible CCS have a clinically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, and other common solid tumors) and are in the rehabilitation/maintenance phase or have completed treatment ≥6 months prior to enrollment. Participants must have no cognitive impairment and be able to understand, communicate, and complete assessments. Primary caregivers aged ≥20 years who provide daily care for eligible CCS will also be included. All participants will provide informed consent/assent. This cohort captures diverse cancer types and survivorship stages to examine symptom clusters, their longitudinal trajectories, and related psychosocial and biological factors, including gut microbiota and metabolites.
Cohort
Prospective
Not listed
Symptom Cluster Severity and Structure in Childhood Cancer Survivors
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.
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The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Fujian Maternity and Child Health Hospital
Collaborator
Jiangxi Province Children's Hospital
Collaborator
