Subjective Toxicity Profiles of Children With Cancer During Treatment: A Latent Class Analysis.

BACKGROUND: Children and adolescents may experience a variety of subjective adverse events (AEs) caused by cancer treatment. The identification of distinct groups of patients is crucial for guiding symptomatic AE management interventions to prevent AEs from worsening. OBJECTIVE: The aim of this study was to identify subgroups of children with cancer experiencing similar patterns of subjective toxicities and evaluate differences among these subgroups in demographic and clinical characteristics. METHODS: A cross-sectional survey was conducted of 356 children in China with malignancies who received chemotherapy within the past 7 days using the pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. A latent class analysis (LCA) was conducted to identify subgroups of patients with distinct profiles of symptomatic AE occurrence. RESULTS: Nausea (54.5%), anorexia (53.4%), and headache (39.3%) were the top 3 AEs children experienced. Nearly all participants (97.8%) experienced ≥1 core AEs, and 30.3% experienced ≥5 AEs. The LCA results identified 3 subgroups ("high gastrotoxicity and low neurotoxicity" [53.2%], "moderate gastrotoxicity and high neurotoxicity" [23.6%], and "high gastrotoxicity and high neurotoxicity" [22.8%]). The subgroups were differentiated by monthly family per-capita income, time since diagnosis, and Karnofsky Performance Status score. CONCLUSIONS: Children experienced multiple subjective toxicities during chemotherapy, especially gastrotoxicity and neurotoxicity. Heterogeneity was found in the LCA in the patients' toxicities. The prevalence of toxicities could be distinguished by the children's characteristics. IMPLICATIONS FOR PRACTICE: The results showing different subgroups in our study may assist clinical staff in focusing on patients with higher toxicities to provide effective interventions.

A Predictive Model of Severe Cytokine Release Syndrome After Coadministration of CD19- and CD22-Chimeric Antigen Receptor T-Cell Therapy in Children With B-Cell Hematological Malignancies Based on Patient-Reported Outcomes.

BACKGROUND: Chimeric antigen receptor T-cell therapy-related severe cytokine release syndrome (sCRS) has seriously affected the life safety of patients. OBJECTIVE: To explore the influencing factors of sCRS in children with B-cell hematological malignancies and build a risk prediction model. METHODS: The study recruited 115 children with B-cell hematological malignancies who received CD19- and CD22-targeted chimeric antigen receptor T-cell therapy. A nomogram model was established based on symptomatic adverse events and highly accessible clinical variables. The model discrimination was evaluated by the area under the receiver operating characteristic curve. The calibration of our model was evaluated by the calibration curve and Hosmer-Lemeshow test. The bootstrap self-sampling method was used to internally validate. RESULTS: Thirty-seven percent of the children experienced sCRS. Indicators included in the nomogram were tumor burden before treatment, thrombocytopenia before pretreatment, and the mean value of generalized muscle weakness and headache scores. The results showed that the area under the receiver operating characteristic curve was 0.841, and the calibration curve showed that the probability of sCRS predicted by the nomogram was in good agreement with the actual probability of sCRS. The Hosmer-Lemeshow test indicated that the model fit the data well (χ2 = 5.759, P = .674). The concordance index (C-index) obtained by internal validation was 0.841 (0.770, 0.912). CONCLUSIONS: The nomogram model constructed has a good degree of discrimination and calibration, which provides a more convenient and visual evaluation tool for identifying the sCRS. IMPLICATIONS FOR PRACTICE: Incorporation of patient-reported outcomes into risk prediction models enables early identification of sCRS.

Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing.

BACKGROUND: The original English Pediatric Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) captures symptomatic adverse events (AEs) in cancer clinical trials from the perspective of pediatric patients. A Chinese version was needed to encourage the use of the Pediatric PRO-CTCAE among Chinese pediatric oncology patients. OBJECTIVE: This study translated and linguistically validated a simplified Chinese version of the Pediatric PRO-CTCAE for oncological patients aged 7 to 18 years. METHODS: Following the Functional Assessment of Chronic Illness Therapy translation methodology, 130 questions were translated into Chinese. Semistructured cognitive interviews investigated the comprehensibility and clarity of terms for symptoms, attributes, and response options. Two rounds of interviews were conducted with 48 native Chinese-speaking children aged 7 to 18 years who were undergoing chemotherapy or radiotherapy treatment. RESULTS: Most items, response options, and recall periods were well understood by children across the age range in round 1. Nineteen items posed comprehension difficulties for 9 participants and were revised and retested without further difficulties. CONCLUSIONS: The Pediatric PRO-CTCAE was successfully developed and linguistically validated among Chinese oncology patients. The results indicated that the Chinese Pediatric PRO-CTCAE was semantically and conceptually equivalent to the English version. IMPLICATIONS FOR PRACTICE: The availability of the simplified Chinese Pediatric PRO-CTCAE will facilitate the generation of patient-reported outcome data about symptomatic AEs for children with cancer in China and thus improve our understanding of children's experience of treatment-related symptoms.

Development and usability test of a symptom management WeChat Mini Program for parents of children with cancer.

Objective: Symptom management is a persistent challenge in pediatric oncology. The WeChat Mini Program, a small smartphone application that functions within WeChat, has the potential to assist in symptom management. This study aimed to develop a symptom management WeChat Mini Program for parents and children with cancer aged 5-17 years old and evaluate its usability. Methods: Based on the semi-structured interviews with parents of children with cancer, experts in pediatric oncology and informatics and a survey of children's symptom experience, multidisciplinary research group meetings were conducted to confirm the structure and main contents of the Mini Program. The iterative method was used to develop the Mini Program. A mixed-method study was conducted to test its usability with 10 pairs of parents and children with cancer. The quantitative data were collected through the Poststudy System Usability Questionnaire, and qualitative data were collected from interviews. Results: The Mini Program "Child SMILE" was developed, which includes a symptom assessment and management module, an information and emotional support module, a communication module among the parents and medical professionals, and a personal information module. Most users reported that the Mini Program is user-friendly, with satisfaction scores on the Poststudy System Usability Questionnaire ranging from 5.2 to 5.7 (out of 7.0) in four dimensions. In qualitative interviews, most participants thought the Mini Program was convenient, easy to use, and helpful. Conclusions: It can be concluded that the Mini Program satisfies the needs of parents of children with cancer and has the potential to benefit the symptom management of children with cancer.