BACKGROUND: Anxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting in this vulnerable group. This trial aims to evaluate the effects of IVR intervention on anxiety, chemotherapy-induced nausea and vomiting and anticipatory nausea and vomiting in patients with paediatric cancer receiving first chemotherapy.
METHODS: An assessor-blinded, randomised controlled trial with a mixed methods evaluation approach. On the basis of our pilot results, 128 chemotherapy-naive patients with paediatric cancer scheduled to receive their first intravenous chemotherapy will be recruited from a public hospital and randomly allocated to intervention (n=64) or control groups (n=64). The intervention group will receive the IVR intervention for three sessions: 2 hours before the first chemotherapy, 5 min before and during their first chemotherapy and 5 min before and during their second chemotherapy, respectively. The control group will receive standard care only. A subsample of 30 participants in the intervention group will be invited for a qualitative interview. Study instruments are: (1) short form of the Chinese version of the State Anxiety Scale for Children, (2) visual analogue scale for anticipatory nausea and vomiting, (3) Chinese version of the Multinational Association of Supportive Care in Cancer Antiemesis Tool and (4) individual face-to-face semistructured interviews to explore intervention participants\' perceptions of the IVR intervention.
BACKGROUND: This study has been approved by the Hong Kong Children\'s Hospital Research Ethics Committee (HKCH-REC-2021-009). The findings will be disseminated in peer-reviewed journals and through local or interventional conference presentations.
BACKGROUND: ChiCTR2100048732.

Childhood cancer survivors (CCSs) who transition through adolescence and enter young adulthood may suffer psychological, cognitive, social, fertility, and sexual issues and concerns. There is an urgent need for comprehensive intervention strategies to improve the transition of CCSs. Web-based technologies are gaining momentum as a new mechanism to provide healthcare and education for adolescents. However, previous frameworks have been limited in their effectiveness in explaining web-based interventions.This realist synthesis aims to synthesise current evidence on transition of CCSs to develop a framework for web-based interventions. The framework can foster understanding of the integrity of web-based intervention implementation chain, examine which mechanistic factors will be triggered by web-based interventions, note and examine the flows, blockages and points of contention in the implementation, to refine web-based interventions.
A realist synthesis that adheres to the Realist and Meta-narrative Evidence Syntheses-Evolving Standard will be used. Studies will be identified through PubMed, Web of Science, EMBASE, PsycINFO, CINAHL, Ovid and Cochrane Library from the period of January 2005 to May 2023. We will also search the reference lists provided in relevant studies and reviews. Articles will be screened based on two principles: (1) Relevance: does the research address the initial programme theory? (2) Rigour: whether a particular inference drawn by the original researcher has sufficient weight to make a methodologically credible contribution to the test of the initial programme theory. No restrictions regarding the design or language of publication will be considered.
As a review, ethical approval is not required. The results from this study will be presented at international conferences and disseminated through peer-reviewed publications. Patients and the public will be involved in the dissemination plans.

In young women with anti-N-methyl-D-aspartate receptor (anti-NMDAR) autoimmune encephalitis (AE), co-occurrence with ovarian teratoma is common. While the management of mature teratoma with AE is well documented, literature on managing immature teratoma (IT) in tandem with AE is relatively scarce. Here, we report a case of a female patient in her early adolescence who presented with abdominal pain and was diagnosed with grade 3 IT combined with anti-NMDAR AE after an ovarian tumour was discovered and resected. Postsurgery, the patient received immunotherapy, chemotherapy and antiepileptic therapy, and two follow-up evaluations showed no signs of recurrence or sequelae. This case highlights the importance of a high index of suspicion for concurrent AE in the presence of ovarian teratoma, particularly IT, and the crucial role of concurrent administration of immunotherapy and chemotherapy following tumour resection in impacting prognosis.

Cancer and its treatment affect children\'s physical, psychological and social well-being throughout the disease trajectory. Spiritual well-being is a fundamental dimension of people\'s overall health and is considered a source of strength to motivate patients to cope with and adapt to their disease. Appropriate spiritual interventions are important to mitigate the psychological impact of cancer on children, with an ultimate goal of improving their quality of life (QoL) throughout the treatment course. However, the overall effectiveness of spiritual interventions for paediatric patients with cancer remains unclear. This paper describes a protocol to systematically summarise the characteristics of studies related to existing spiritual interventions and synthesise their effectiveness on psychological outcomes and QoL among children with cancer.
Ten databases will be searched to identify appropriate literature: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, PsycINFO, LILACS, OpenSIGLE, the Chinese Biomedical Literature Database, the Chinese Medical Current Contents and the Chinese National Knowledge Infrastructure. All randomised controlled trials that meet our inclusion criteria will be included. The primary outcome will be QoL as evaluated by self-reported measures. The secondary outcomes will be self-reported or objectively measured psychological outcomes, including anxiety and depression. Review Manager V.5.3 will be used to synthesise the data, calculate treatment effects, perform any subgroup analyses and assess the risk of bias in included studies.
The results will be presented at international conferences and published in peer-reviewed journals. As no individual data will be involved in this review, ethical approval is not required.

BACKGROUND: Diagnosis and treatment represent distressing experiences for the families of children with cancer. Psychosocial challenges are faced by these families in China because of limited health services and resources for psychosocial oncology care. Effective interventions tailored to the knowledge level and cultural values of this population are needed. The goal of this study is to evaluate a smartphone-based care support (SBCS) programme for the families of children with cancer in China.
METHODS: A parallel randomised controlled trial will be conducted to examine the efficacy of an evidence-based and culturally tailored SBCS programme for the families of children with cancer in China. A total of 180 families will be recruited. The intervention will consist of an introduction session and four main sessions and will be conducted sequentially on a single weekend day. Participating families will be included in the intervention group. The post-traumatic stress and quality of life of families will be evaluated at baseline, during the intervention, immediately after the intervention, and 2 and 6 months after the intervention.
BACKGROUND: Ethical approval for this protocol has been obtained from the Nursing and Behavioural Medicine Research Ethics Review Committee, Xiangya School of Nursing, Central South University (Protocol #: E2020125). The findings of the trial will be disseminated through conference presentations and publications in peer-reviewed journals.
BACKGROUND: ChiCTR2000040510.

OBJECTIVE: The objective of this work is to compare posttraumatic stress symptoms (PTSS) between families of children on cancer treatment and families of healthy children in China and to analyse the association among child PTSS, parent PTSS, and depression in the cancer group.
METHODS: Participants were children on cancer treatment (n = 91) and their parents (n = 91), and healthy children (n = 114) and their parents (n = 96). The children were asked to self-report PTSS, and the parents completed self-reported measures of PTSS and depression.
RESULTS: Although the prevalence of probable PTSD in children on cancer treatment was higher than that in comparisons (8.79% vs. 0.88%, P < 0.01), no statistic differences in PTSS levels were found between the two groups (P > 0.05). However, significant differences in PTSS levels and the prevalence of severe PTSS (21.98% vs. 1.04%) between parents of children with cancer and comparisons were observed (P < 0.001). Parent PTSS and depression were positively associated with child PTSS in the cancer group (P < 0.01).
CONCLUSIONS: The prevalence of probable PTSD in Chinese children with cancer was low, but PTSS was remarkably prevalent in their parents. Greater parent PTSS and depression were related to greater child PTSS. Results underline the importance to provide supportive psychological care for Chinese parents of children undergoing cancer treatment.

The seventh multi-stakeholder Paediatric Strategy Forum focused on chimeric antigen receptor (CAR) T-cells for children and adolescents with cancer. The development of CAR T-cells for patients with haematological malignancies, especially B-cell precursor acute lymphoblastic leukaemia (BCP-ALL), has been spectacular. However, currently, there are scientific, clinical and logistical challenges for use of CAR T-cells in BCP-ALL and other paediatric malignancies, particularly in acute myeloid leukaemia (AML), lymphomas and solid tumours. The aims of the Forum were to summarise the current landscape of CAR T-cell therapy development in paediatrics, too identify current challenges and future directions, with consideration of other immune effector modalities and ascertain the best strategies to accelerate their development and availability to children. Although the effect is of limited duration in about half of the patients, anti-CD19 CAR T-cells produce high response rates in relapsed/refractory BCP-ALL and this has highlighted previously unknown mechanisms of relapse. CAR T-cell treatment as first- or second-line therapy could also potentially benefit patients whose disease has high-risk features associated with relapse and failure of conventional therapies. Identifying patients with very early and early relapse in whom CAR T-cell therapy may replace haematopoietic stem cell transplantation and be definitive therapy versus those in whom it provides a more effective bridge to haematopoietic stem cell transplantation is a very high priority. Development of approaches to improve persistence, either by improving T cell fitness or using more humanised/fully humanised products and co-targeting of multiple antigens to prevent antigen escape, could potentially further optimise therapy. Many differences exist between paediatric B-cell non-Hodgkin lymphomas (B-NHL) and BCP-ALL. In view of the very small patient numbers with relapsed lymphoma, careful prioritisation is needed to evaluate CAR T-cells in children with Burkitt lymphoma, primary mediastinal B cell lymphoma and other NHL subtypes. Combination trials of alternative targets to CD19 (CD20 or CD22) should also be explored as a priority to improve efficacy in this population. Development of CD30 CAR T-cell immunotherapy strategies in patients with relapsed/refractory Hodgkin lymphoma will likely be most efficiently accomplished by joint paediatric and adult trials. CAR T-cell approaches are early in development for AML and T-ALL, given the unique challenges of successful immunotherapy actualisation in these diseases. At this time, CD33 and CD123 appear to be the most universal targets in AML and CD7 in T-ALL. The results of ongoing or planned first-in-human studies are required to facilitate further understanding. There are promising early results in solid tumours, particularly with GD2 targeting cell therapies in neuroblastoma and central nervous system gliomas that represent significant unmet clinical needs. Further understanding of biology is critical to success. The comparative benefits of autologous versus allogeneic CAR T-cells, T-cells engineered with T cell receptors T-cells engineered with T cell receptor fusion constructs, CAR Natural Killer (NK)-cell products, bispecific T-cell engager antibodies and antibody-drug conjugates require evaluation in paediatric malignancies. Early and proactive academia and multi-company engagement are mandatory to advance cellular immunotherapies in paediatric oncology. Regulatory advice should be sought very early in the design and preparation of clinical trials of innovative medicines, for which regulatory approval may ultimately be sought. Aligning strategic, scientific, regulatory, health technology and funding requirements from the inception of a clinical trial is especially important as these are very expensive therapies. The model for drug development for cell therapy in paediatric oncology could also involve a \'later stage handoff\' to industry after early development in academic hands. Finally, and very importantly, strategies must evolve to ensure appropriate ease of access for children who need and could potentially benefit from these therapies.

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To investigate the effectiveness and safety of tyrosine kinase inhibitors (TKIs) in the management of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL).
A systematic review and meta-analysis.
Electronic searches were conducted on CENTRAL, MEDLINE, EMBASE, SIOP, ASPHO, ASCO, ASH and four Chinese databases from inception to 8 March 2020. Language of publications was restricted in English and Chinese.
Prospective and retrospective comparative studies were included.
Two authors independently assessed and extracted data. Quality of studies was assessed by the Cochrane Collaboration\'s tool and Newcastle-Ottawa Scale. Subgroup analysis was performed by comparing different types of TKIs. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.
Two randomised controlled trials (RCTs) and four cohort studies enrolling 536 patients were included. For RCTs, the pooled HR was 0.68 (95% CI 0.26 to 1.78) in overall survival (OS), 0.63 (95% CI 0.28 to 1.42) in event-free survival (EFS), respectively, comparing TKI arm with non-TKI arm for treatment of paediatric Ph+ALL. There was significant difference in OS and EFS between imatinib arm and dasatinib arm (HR 2.26, 95% CI 1.02 to 5.01; HR 2.36; 95% CI 1.27 to 4.39, respectively). For cohort studies, the pooled HR was 0.25 (95% CI 0.14 to 0.47) in OS, 0.25 (95% CI 0.12 to 0.56) in EFS, respectively, comparing TKI arm with non-TKI arm. There was no significance difference in adverse drug reaction between TKI group and without TKI group (risk ratio (RR) 0.82, 95% CI 0.63 to 1.08 in RCT; RR 1.01, 95% CI 0.64 to 1.59 in cohort studies; respectively), and imatinib versus dasatinib (RR 0.97, 95% CI 0.77 to 1.23). The quality of evidence was rated as low for OS, EFS and adverse drug reaction (ADR).
The combination of TKIs with chemotherapy is likely to improve the OS and EFS rates in paediatric Ph+ALL, and dasatinib is superior than imatinib. Large sample size and prospective controlled studies are warranted.
CRD42018104107.

Large B-cell lymphoma with IRF4 rearrangement, and Burkitt-like lymphoma with 11q aberration are two provisional lymphoma entities in the 2017 revision of the WHO classification of lymphoid neoplasms. Despite being more frequent in young patients, knowledge regarding their true incidence and clinical features in unselected cohorts of paediatric and adolescent patients is limited. We screened for both entities among paediatric patients (<18 years of age) in the German NHL-BFM (Non-Hodgkin lymphoma Berlin-Frankfurt-Münster) group. Among follicular lymphomas and diffuse large B-cell lymphomas (DLBCL), 7/34 cases (21%) showed an IRF4 break-apart pattern by fluorescence in situ hybridisation (FISH) and are associated with stages I and II disease (P = 0·043). Among lymphomas morphologically resembling Burkitt lymphoma, DLBCL and high-grade B-cell lymphoma, unclassifiable, 13/102 cases (13%) lacked a MYC break-apart pattern but were positive for 11q proximal gain and telomeric loss by FISH. MYC-negative Burkitt-like lymphomas with the typical 11q gain-loss pattern by FISH were older (P = 0·004), showed less male predominance (P = 0·003), lower stage (P = 0·040), lower serum LDH level (P = 0·01) and less abdominal involvement (P = 0·008) compared to high grade B-cell lymphomas without 11q gain-loss pattern. Both entities showed excellent outcome with overall survival of 100% when managed according to NHL-BFM strategies and may provide candidates for future therapy de-escalation in clinical trials.