Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

Summary

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.

Eligibility

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.

Conditions3

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