The NEMO Project: Longitudinal Monitoring of Neuropsychological Outcomes in Pediatric Oncology

Children with cancer may experience neuropsychological impairments and there is
increasing evidence that many cancer groups are at-risk. Most studies have
focused on long-term survivors, but some impairments are shown shortly after
diagnosis which could be due to the disease itself, neurotoxicity of treatments
(e.g., cranial radiation, intensive chemotherapies), stress, and/or fatigue.
These results suggest that early monitoring is necessary across pediatric
oncology groups, including brain tumors, solid tumors, and hemato-oncological
conditions. However, comprehensive evaluations are not feasible or necessary to
conduct with all patients, and thus, brief measures that are sensitive to
impairments are essential to follow patients and to implement services in a
timely manner. Previous studies have only completed screening assessments at
one time point and compared patient performance to group normative data, which
may miss information due to variability across time or between patients.
Rather, subtle changes within individual patients may occur over time, and
these changes may be associated with functional outcomes such as intelligence
or levels of independence. Along with consideration of bio-psycho-social risk
factors, we hypothesize that changes in cognition or behavior over time can
identify those who are most at-risk of functional impairments. This research
will assist in developing neuropsychology monitoring programs, which will
ultimately lead to earlier detection of and intervention for neuropsychological
deficits in pediatric oncology. We also hypothesize that results may differ
between treatment units, suggesting that each unit requires a tailor-made
program.

The primary objective is to examine whether changes over time in monitoring
measures of cognition and behavior are associated with functional outcomes in
pediatric oncology groups. Additional objectives are to examine trajectories,
risk factors, and frequencies of neuropsychological impairment in early phases
of treatment and survivorship as well as to determine the feasibility and
acceptability of a neuropsychology monitoring program.

Single-center, prospective observational cohort study

This is a non-invasive, observational study and there is no substantial burden;
if any, burden is related to time. Patients and parents/caregivers will be
asked to complete neuropsychological tests and questionnaires at 5 time points
across 2 years. The brief monitoring assessments are completed every 6 months
(30 min for patients; 15 min for parents). At the first and last assessment,
more comprehensive testing will be completed. If a patient is not seen for
care, these assessments will take an additional 115-120 minutes for patients
and 30-35 more minutes for parents. Brain tumor patients and those referred for
neuropsychological assessments will complete these tests as part of standard
care; in these cases, it will only take an additional 20-25 minutes for
patients to participate in this study. The most important tasks for our
research questions are completed within the first 30-45 min of the assessment,
and thus data is still obtained if testing needs to be shortened that day
(i.e., due to fatigue, limited time). Furthermore, appointments will be
combined with regularly scheduled appointments and there are opportunities for
breaks or rescheduling the appointment if needed. Most questionnaires can be
completed at home through the online KLIK portal. There are no anticipated
risks for participation. One potential benefit is that parents will receive a
summary of results from the comprehensive assessments (and will be referred for
services when needed). Otherwise, there are no direct benefits for
participation and results will be used to optimize care for future patients.