Background
Children with cancer were designated as clinically extremely vulnerable if they were to contract SARS‐CoV‐2 due to immune suppression in the early phase of the COVID‐19 pandemic. Our aim ...was to explore experiences, information and support needs, and decision making of parents with a child with cancer in response to this phase in the United Kingdom.
Methods
Parents of a child with cancer completed a survey at a time when the UK moved into a period of ‘lockdown’. An online survey was developed by the research team to capture parents’ experiences, information and support needs, and decision making, using closed statements and open text boxes. Descriptive quantitative analyses and qualitative thematic content analysis were undertaken.
Findings
One hundred seventy‐one parents/caregivers completed the survey. Eighty‐five percent were worried about the virus and they were vigilant about the virus (92%) or cancer symptoms (93.4%). For two‐thirds (69.6%), hospital was no longer considered a safe place. Eight overarching themes were identified related to the virus: (a) risk of infection; (b) information, guidance and advice; (c) health care provision; (d) fears and anxieties; or related to lockdown/isolation: (e) psychological and social impact; (f) keeping safe under lockdown; (g) provisions and dependence; and (h) employment and income.
Conclusions
This is the first study, to the best of our knowledge, to report experiences of parents of a child with cancer during the SARS‐CoV‐2/COVID‐19 pandemic. The majority of parents were worried about SARS‐CoV‐2 and transmitting the virus to their child. Hospital was no longer perceived to be a safe place, and parents were worried about suboptimal cancer care. Parents described fear and anxiety and the psychological, social and economic impact of isolation.
Objectives
Novel therapies, such as, small protein molecule inhibitors and immunotherapies are first tested clinically in Phase I trials. Moving on to later phase trials and ultimately standard ...practice. A key aim of these early clinical trials is to define a toxicity profile; however, the emphasis is often on safety. The concern is cognitive toxicity is poorly studied in this context and may be under‐reported. The aim of this review is to map evidence of cognitive assessment, toxicity, and confounding factors within reports from Phase I trials and consider putative mechanisms of impairment aligned with mechanisms of novel therapies.
Methods
A scoping review methodology was applied to the search of databases, including Embase, MEDLINE, Clinicaltrials.gov. A keyword search was conducted, results screened for duplication then inclusion/exclusion criteria applied. Articles were further screened for relevance; data organised into categories and charted in a tabular format. Evidence was collated and summarised into a narrative synthesis.
Results
Despite the availability of robust ways to assess cognitive function, these are not routinely included in the conduct of early clinical trials. Reports of cognitive toxicity in early Phase I trials are limited and available evidence on this shows that a proportion of patients experience impaired cognitive function over the course of participating in a Phase I trial. Links are identified between the targeted action of some novel therapies and putative mechanisms of cognitive impairment.
Conclusion
The review provides rationale for research investigating cognitive function in this context. A study exploring the cognitive function of patients on Phase I trials and the feasibility of formally assessing this within early clinical trials is currently underway at the Royal Marsden.
Patient-reported outcomes (PROs) are the gold standard to assess the patients’ subjective health status. While both the Food and Drug Administration and European Medicines Agency recommend the use of ...PROs as end-points in paediatric clinical trials to support claims for medical product labelling, it is not known how often PROs are actually used. The aim of this study was to assess the usage of PRO instruments in childhood cancer clinical trials investigating anti-cancer medication.
In June 2020 ClinicalTrials and EudraCT were systematically searched for all trials including children and adolescents (≤21 years) with cancer registered between 2007 and 2020. The use of PRO measures and trials characteristics were analysed. To investigate which trial characteristics are associated with the use of PROs, a binary logistic regression was calculated.
Of 4789 identified trials, 711 were included. The most frequent reason for exclusion was age limitation (age >21 years). Of all included trials, only 8.2% used PROs as end-points; .6% as the primary end-point. The most commonly used questionnaire was the PedsQL™ (32.8%), followed by the Patient-Reported Outcomes Measurement Information System scales (12.1%). No association was observed between the use of PROs and trial region, number of centres, trial phase, time period or intervention type (all p > .05). The use of PROs did not substantially increase over time. Only 20.3% of the closed studies had published their results.
Despite recommendations of regulatory agencies, PRO assessment is extremely rare in paediatric oncology clinical trials. More efforts should be undertaken to facilitate implementation of PRO in paediatric trials to guarantee patient-centred research and treatments.
•Patient-reported outcome measures (PROMs) are extremely rare in childhood cancer trials.•No substantial increase in PROM assessment observed in children with cancer over time.•More efforts are needed to facilitate implementation of PROMs in paediatric oncology.
Abstract Context Approximately 25% of children diagnosed with cancer eventually die. Losing a child puts parents at increased risk for developing psychological problems. Objectives To explore ...parents' perceptions of the interaction with health care professionals (communication, continuity of care, and parental involvement) and symptom management during the pediatric palliative phase, and to investigate the influence on long-term grief in parents who lost a child to cancer. Methods A total of 89 parents of 57 children who died of cancer between 2000 and 2004 participated in this retrospective cross-sectional study by completing a set of questionnaires measuring grief (Inventory of Traumatic Grief), parents' perceptions of the interaction with health care professionals (communication, continuity of care, and parental involvement), and symptom management during the palliative phase. Care was assessed on a five point Likert scale (1 = disagree and 5 = agree). Results Parents highly rated communication (4.6 ± 0.6), continuity of care (4.3 ± 0.6), and parental involvement (4.6 ± 0.7) during the palliative phase. Parents' most often reported physical and psychological symptoms of their child during the palliative phase were fatigue (75%), pain (74%), anxiety to be alone (52%), and anger (48%). Higher ratings of parents on communication (β = −9.08, P = 0.03) and continuity of care (β = −11.74, P = 0.01) were associated with lower levels of long-term parental grief. The severity of the child's dyspnea (β = 2.96, P = 0.05), anxiety to be alone (β = 4.52, P < 0.01), anxiety about the future (β = 5.02, P < 0.01), anger (β = 4.90, P < 0.01), and uncontrolled pain (β = 6.60, P < 0.01) were associated with higher levels of long-term parental grief. Multivariate models combining the interaction with health care professionals and symptom management showed a significant influence of both aspects on long-term parental grief. Conclusion Both interaction with health care professionals, especially communication and continuity of care, and symptom management in children dying of cancer are associated with long-term parental grief levels.
Background
Living with a life threatening/limiting condition changes and challenges children's play. The environment is known to support participation in play, yet there is a lack of evidence ...highlighting its specific factors contributing to children's play. In this study, we investigated the perspectives of children living with life threatening/limiting conditions with regard to the environmental factors that are related to their engagement in play whilst receiving inpatient healthcare.
Methods
Twenty‐seven children took part in this study. Participants were aged between 5 and 11 years, diagnosed with life threatening/limiting conditions and were receiving care at either a children's hospital or hospice in either Kuwait or the United Kingdom. Children were asked to rank‐order a Q set according to their perceived importance. The used Q set composed of social and physical environmental factors. The data were analysed using factor analysis and content analysis.
Findings
Two shared viewpoints were identified, which represented children from both countries. For Factor 1, the children's need for social connectivity guided their answers regarding the environmental factors. For Factor 2, although children considered being surrounded by others important, their selections of the play conditions directed their play. For both factors, children had relatively little concern for outdoor and the type of play to engage in, with the exception of arts and crafts play activities, which were deemed important.
Conclusions
Play settings are important to support rich, social play experiences and opportunities that match children's play preferences. Children living with life threatening/limiting conditions in Kuwait and the United Kingdom have relatively similar play needs.
Surviving childhood cancer and surviving cancer in adolescence or young adulthood may present with psychosocial similarities and differences. A clearer delineation for these 2 groups is warranted.
Aim
To compare indicators of high‐intensity treatment at end‐of‐life (HI‐EOL) among children according to causes of death.
Methods
We conducted a nationwide registry study in Denmark among 938 ...children of 1‐17 years of age who died from natural causes from 2006 to 2016. We identified and compared indicators of HI‐EOL within the last month of life across diagnoses. Indicators were hospital admissions, days in hospital, intensive care unit admission, mechanical ventilation, and hospital death.
Results
Proportions of each indicator of HI‐EOL ranged from 27% to 75%. The most common indicators were hospital death (75%) and ICU admission (39%). Compared to children with solid tumours, children with non‐cancerous conditions had an adjusted odds ratio of 3.5 (95% CI 2.1‐5.9) of having ≥3 indicators of HI‐EOL within the last month of life and children with haematological cancer had an odds ratio of 11.8 (95% CI 6.1‐23.0).
Conclusion
The underlying diagnosis was strongly associated with HI‐EOL. Children who died from solid tumours experienced substantially less intensive treatment than both children with haematological cancer and non‐cancerous conditions did. Across non‐cancerous diagnoses, the intensity of treatment appeared consistent, which may indicate, that the awareness of palliative care is higher among oncologists than within other paediatric fields.
Aim
Understanding of coping strategies that parents use before the death of their child is crucial and will enable us to best provide support. The current study aimed to explore parents’ coping ...strategies, and map these onto an existing theoretical framework.
Methods
Bereaved parents and parents of a child with a life‐limiting/threatening condition were interviewed to investigate coping strategies, recruited through Intensive Care Units (2 Neonatal, 2 Paediatric, 1 Paediatric Cardiac) and a children's hospice. Analysis focused on coping strategies and mapping these onto the framework.
Results
24 parents of 20 children were interviewed and identified. Parents use a variety of coping strategies (n = 25) such as humour, staying positive, advocating and staying strong for others, expressing emotions and preparing, while also living life to the full, supported by others. The themes were successfully mapped onto the theoretical framework, which focuses on the constructs of approach and avoidance, as well as coping for self and others.
Conclusion
The findings have provided a detailed account of the breadth and depth of coping strategies parents use, including those classed as avoidance. The strategies were successfully mapped onto the theoretical framework. Future research should investigate changes over times, and associations to negative long‐term outcomes.
The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance ...to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.
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