The Impact of the Timing of Health-Related Quality of Life Assessments on the Actual Results in Glioma Patients: A Randomized Prospective Study

Abstract

Background: The aim of this study was to explore the impact of the timing of Health-Related Quality of Life (HRQoL) measurements in clinical care on the obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression. Methods: Patients completed the European Organisation for Research and Treatment of Cancer (EORTC)’s Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) twice. All patients completed the first measurement on the day of the Magnetic Resonance Imaging (MRI) scan (t = 0), but the second measurement (t = 1) depended on randomization; Group 1 (n = 49) completed the questionnaires before and Group 2 (n = 51) after the consultation with the physician. Results: median HRQoL scale scores on t0/t1 and change scores were comparable between the two groups. Between 8–58% of patients changed to a clinically relevant extent (i.e., ≥10 points) on the evaluated HRQoL scales in about one-week time, in both directions, with only 3% of patients remaining stable in all scales. Patients with a stable role functioning had a lower HADS anxiety change score. The HADS depression score was not associated with a change in HRQoL. Conclusions: Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level. However, most patients reported a clinically relevant difference in at least one HRQoL scale between the two time points. These findings highlight the importance of standardized moments of HRQoL assessments, or patient-reported outcomes in general, during treatment and follow-up in clinical trials.

Is the EORTC QLQ‐C30 emotional functioning scale appropriate as an initial screening measure to identify brain tumour patients who may possibly have a mood disorder?

“…During the second assessment, patients were randomly assigned to one of two groups: questionnaires were administered 1) before the consultation with the physician or 2) after the consultation with the physician. Further details on the study design and outcomes are described previously 18 . For this study, the outcomes of the first assessment (day of the MRI scan) were used for the primary analyses.…”

“…Data was collected as part of a randomized prospective study measuring the impact of the timing of patient‐reported outcome assessments on the actual HRQoL outcomes in clinical care for glioma patients. 18 Patients were recruited in the Haaglanden Medical Center in The Hague, The Netherlands, between July 2016 and July 2018. Informed consent was obtained from all patients and their proxies included in the study.…”

“…Nevertheless, the current study mainly aimed to determine if the EORTC QLQ‐C30 EF scale is suitable to screen patients for affective symptoms who possibly have a mood disorder, warranting further investigation and perhaps additional attention from the professional caregivers. Furthermore, the level of anxiety and depression in this study may be an overestimation, because these outcomes were assessed at time points that may have increased the patients' levels of anxiety and depression, 18 namely during an MRI scan and the day of the consultation with the physician. The phenomenon “scanxiety”, that is heightened scan‐associated state of psychological distress, has been previously established in other cancer populations 45 .…”

“…Furthermore, the level of anxiety and depression in this study may be an overestimation, because these outcomes were assessed at time points that may have increased the patients' levels of anxiety and depression, 18 namely during an MRI scan and the day of the consultation with the physician. The phenomenon "scanxiety", that is heightened scan-associated state of psychological distress, has been previously established in other cancer populations.…”

“…Data was collected as part of a randomized prospective study measuring the impact of the timing of patient-reported outcome assessments on the actual HRQoL outcomes in clinical care for glioma patients. 18…”