It is now recognised that although cancer survival is the primary goal of treatment, it should not be the only outcome measured in paediatric trials. Consequently, more emphasis is being placed on measuring aspects of physical and psychosocial well-being that contribute to the quality of life of survivors. There is an emphasis (especially in brain tumours) on cognitive outcomes measured by neuropsychological tests. For paediatric patients, quality of life is often measured by proxy report questionnaires (parents answer the questions on behalf of their child) or, in the case of older children, self-report questionnaires (children answer the questions for themselves).
Traditional neurocognitive measures involve specific tasks that must be performed by trained psychologists. They are clinically useful in identifying needs and facilitating interventions, but often require lengthy on-site assessment procedures and can be a burden for patients and their parents. Even when cognitive assessments are clinically recommended, they are not consistently offered as standard treatment in parts of North America and Europe. An optimal approach to assessing cognitive outcomes requires a trade-off between the use of comprehensive testing, which requires a great deal of time, resources and patient burden, and shorter tests, which may be less useful for patient care. In this article, Sophie Thomas and her colleagues describe current approaches to resolving these difficulties recently employed in clinical trials in the USA and Europe.
The Children’s Oncology Group organisation developed two strategies for assessing neuropsychological functioning to meet the unique needs of assessing children with cancer in clinical trials: ALTE07C1 and the computer-based Cogstate battery.
ALTEC07C1 is a free-standing companion protocol designed for trials using traditional cognitive tests. Consensus was obtained from a panel of experts regarding the measures and timing of assessments at three time points (nine, 30 and 60 months after diagnosis). The selected measures are applicable across a wide age range, require relatively little time (60-90 minutes) and have proven relevance to patients’ ‘real-world’ functioning (e.g. academic performance). Areas assessed include global intellectual function, working memory, processing speed, and visual and verbal long-term memory. Parents also complete questionnaires related to health-related quality of life and psychosocial and adaptive functioning. This assessment strategy has proven feasible and successful.
Cogstate is a test battery for computer-based assessment of neuropsychological functioning. There is often a need to evaluate the onset and trajectory of cognitive deficits over the course of therapy and into survivorship in order to detect disease- or treatment-related changes. Cogstate includes tasks to measure cognitive abilities that may change after chemotherapy or radiation (e.g. attention, working memory, processing speed). For example, it is being used to identify the timing and trajectory of neurocognitive decline in children with high-risk leukaemia. Computerised forms of cognitive testing, such as Cogstate, have the potential to reduce testing time, patient and staff burden. It is deliverable by a range of clinic staff with minimal training and so far, there have been few technical problems and very few patients have felt uncomfortable taking the test.
The European branch of the International Society of Paediatric Oncology (SIOP-E) is an organisation that focuses on childhood cancer. SIOP-E has also introduced two new approaches measuring neuropsychological aspects: Core Plus and patient-reported outcomes (questionnaires).
Core Plus includes two versions, the relatively short, so-called Core measure of cognition and quality of survival, and a more comprehensive Plus measure. The two-tiered approach stems from a lack of resources in many centres. The minimum battery of cognitive tests (Core) is recommended for all studies and can be supplemented by the more comprehensive Plus battery. Core Plus is available in several languages and now also covers children under the age of five.
The battery of patient-reported outcomes is suggested for assessing and monitoring health and neuropsychological aspects of brain tumour treatment trials. The battery uses standardised questionnaires to assess behaviour, emotional functioning, health status and health-related quality of life. Recently, an education- and employment-related questionnaire has also been developed.
Creating study protocols to measure cognition and other aspects of quality of survival requires persistence, patience and often compromise. However, recent approaches have been successful in large collaborative studies. Combining both strategies (computerised batteries with approaches using traditional measures) may provide the ability to detect early signs of cognitive problems and describe acute neurotoxicities, whilst also determining the clinical and functional significance of those changes long after cancer treatment has ended. Continued monitoring of the benefits and challenges of these approaches will allow the protocols to be further developed and refined.
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