Table 3.
Outcomes in PRO-GLIO
| Parameter/domain | Measure | Time point |
| Primary endpoint | 2 years | |
| Survival | FIFS | |
| Key secondary endpoints | 2 years | |
| Fatigue | Chalder Fatigue Questionnaire,31 total score | |
| Cognitive impairment | CANTAB, composite z-score of 5 measures of CANTAB score | |
| Further secondary and exploratory endpoints | ||
| PROMs | 5 months, 1, 2, 5, 10 and 15 years | |
| HRQoL | EORTC QLQ-30,39 EQ-5D-5L (health economy40) | |
| Brain tumour-specific symptoms | EORTC QLQ-BN2041 | |
| Fatigue | Chalder Fatigue Questionnaire31 | |
| Mental health (anxiety, depressive symptoms) | GAD-7,42 PHQ-943 | |
| Health literacy | HLS-Q1244 | |
| Personality | Questions similar to the HUNT-3 survey,45 based on Eysenck’s Personality Inventory46 | |
| Sleep and lifestyle, sexuality | Questions similar to the HUNT-4 survey47 | |
| Need for rehabilitation | Questions similar to a former trial at OUH48 | |
| Cognitive screening test (CANTAB) | 5 months, 2, 5, 10, 15 years | |
| Visual attention | Rapid Visual Information Processing (A Prime), Spatial Span Forward (Span length) | |
| Visual learning/memory | Pattern Recognition Memory (% correct immediately, % correct delayed) | |
| Planning/working memory | One Touch Stockings of Cambridge (number solved correctly) | |
| Clinician-rated measures | ||
| Survival | FIFS, median FIFS | 5, 10, 15 years |
| Neurological function | NANO score34 | 2, 5, 10, 15 years |
| General condition | WHO-ECOG status, KPS score | 5 months, 2, 5, 10, 15 years |
| Epilepsy control | Rate of epileptic seizures | 5 months, 2, 5, 10, 15 years |
| Adverse events | AE, SAE and AESI | End of radiotherapy, 3, 5 months, 1, 2, 5, 10, 15 years |
| Cognitive impairment | Traditional neuropsychological testing* | 5 months, 2, 5, 10, 15 years |
| Objective | ||
| Survival | OS, PFS, median PFS, median OS | 2, 5, 10, 15 years |
| Pattern of progression/recurrence (local, distant or combined) | RANO32 | 2, 5, 10, 15 years |
| Concomitant medication | Corticosteroid and AED dose | 5 months, 2, 5, 10, 15 years |
| Basal endocrinological status | Blood tests | Yearly |
| Health economics | 2, 5, 10, 15 years | |
| Incremental cost-effectiveness ratio | Difference in mean cost between groups divided by differences in mean QALYs | |
| Cost related to loss of production caused by disease and treatment | Healthcare costs: treatment, follow-up and transportation Societal costs: production loss for patients and caregivers |
|
| Lifetime cost/benefit for patients | QALYs | |
*Norwegian and some Swedish patients only.
AE, adverse event; AED, anti-epileptic drug; AESI, adverse event of special interest; CANTAB, CAmbridge Neuropsychological Test Automated Battery; EORTC QLQ-30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-BN20, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm; EQ-5D-5L, EuroQol-5 Dimensions-5 level; FIFS, first intervention-free survival; GAD-7, Generalized Anxiety Disorder Assessment; HLS-Q12, European Health Literacy Survey Questionnaire, short version; HRQoL, health-related quality of life; HUNT, Health Survey North Trøndelag county; KPS, Karnofsky Performance Status; NANO, Neurological Assessment in Neuro-Oncology; OS, overall survival; OUH, Oslo University Hospital; PFS, progression-free survival; PHQ-9, Patient Health Questionnaire; PRO-GLIO, PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas; PROMs, patient-reported outcome measures; QALYs, quality-adjusted life years; RANO, Response Assessment in Neuro-Oncology; SAE, serious adverse event; WHO-ECOG, World Health Organisation- Eastern Cooperative Oncology Group.