Search

AIMS Trial registration supports unbiased reporting of research studies. Despite inconsistent use globally and sub-optimal completeness, registration is associated with publication of the same outcomes as defined in trial protocols, though these are not necessarily reported in published results. In the core outcomes in brain tumour trials (COBra) study a registry review was undertaken, alongside a systematic review of qualitative literature and semi-structured interviews, to develop a core outcome set (COS) outcome longlist. The study aims to identify all outcomes reported across all glioma trial registration data. METHOD Phase 3 interventional glioma trials involving patients aged 18 and over, registered on clinicaltrials.gov or the ISRCTN registry were included. Two researchers independently searched the databases and registered data and available protocols were retrieved. Two reviewers independently extracted basic trial data including primary and secondary outcomes. Outcomes were categorised according to an ontology developed through literature review. RESULTS 91 trials were identified. Primary outcome categories reported were survival (84%), disease activity (14%), symptoms (4%), adverse events (3%) and resource use (1%). Secondary outcome categories reported were survival (60%), adverse events (52%), quality of life (QoL, 41%), disease activity (30%), symptoms (20%), function (12%), resource use (7%), health status (7%), and economic (3%). The review contributed 15 unique outcomes to the final outcome longlist of 35. CONCLUSION Trial registries represent a pragmatic solution in COS development and enabled identification of outcomes not present in other data sources. Under half of registered glioma studies included QoL outcomes; a small minority included functional outcomes or economic evaluation.

AIMS Glioma, the most common primary brain tumour, has variable survival rates. Existing evidence describes detriment to quality of life from persistent symptoms/side effects, functional loss and feelings of disconnection, particularly in glioblastoma; however, there remains limited focus on the experience of longer-term survivors. This study aimed to ascertain the lived experience of people with glioma and their caregivers, part of a larger study identifying outcomes for a core outcome set for use in glioma trials (COBra study). METHOD Semi-structured interviews with UK glioma patients, or patient-caregiver dyads, analysed using Thematic Analysis. RESULTS Nineteen interviews were undertaken. Patients and caregivers described living with uncertainty long after diagnosis and treatment, including prognostic uncertainty and anxiety surrounding recurrence and worsening symptoms. Patients described an inability to plan long-term, struggling to return to normal activities, either due to progressive tumour symptoms, and/or treatment side effects. Long-term physical and psychological side effects were highly impactful; patients felt left alone to cope, with support following treatment dropping off rapidly. Patients/caregivers sought self-directed ways to cope, focusing on routine and achieving some normality. However, the physical and neurological effects of glioma and its treatment affected all aspects of daily life and social interactions, impacting on sense of wellbeing and quality of life. CONCLUSION People with glioma, and their caregivers, struggle with loss of normality and living with uncertainty long after diagnosis. They proactively engage in self-directed approaches towards mitigating these effects, but experience gaps in support after treatment finishes. Clinical follow up should target these aspects of assessment and intervention.

BACKGROUND Most primary brain tumour patients rely on informal caregivers (i.e. family members or friends) for practical and emotional support. While caregiving can be rewarding, it may lead to significant burden. To develop support it is therefore vital to distinguish between unmet needs, and an actual wish for support. Study aims: 1) identify the presence and magnitude of caregivers’ unmet needs; 2) examine associations between unmet needs and wish for support; 3) evaluate perceived usefulness of caregiver needs screening in clinical practice. METHODS Family caregivers of primary brain tumour patients were recruited and asked to complete an adapted version of the Caregiver Needs Screen (CNS) which consisted of 33 common issues in neuro-oncology caregiving (scale 0-10), and the wish for support (yes/no). Participants ranked (0-7) their experience of using the CNS with a study-specific evaluation questionnaire. Descriptive and correlational analyses were applied. RESULTS Caregivers (N=79) reported between 1-33 unmet needs (M=17.20, sd=7.98) but did not always wish for support (range 0-28, M=4.71, sd=6.63). Most distressing items were changes in patient’s memory or concentration (M=5.75, SD=3.29), followed closely by patient’s fatigue (M=5.58, SD= 3.43), and recognising signs of disease progression (M=5.23, SD= 3.15). A weak correlation was found between the total number of unmet needs and wish for support (r=0.296, p=0.014). Caregivers most often wished for support with recognising disease progression (N=24, 34.78%), and least often with managing spiritual issues (N=0, 0%). Caregivers evaluated the CNS tool positively (mean item scores ranging 4.19-6.21 out of 7). CONCLUSIONS Family caregivers experience distress resulting from many neuro-oncology specific needs, but this is not directly related to a wish for support. Caregiver needs screening could be useful to tailor support to suit caregivers’ preferences in clinical practice.

Aims Patients with brain tumours and headache commonly have poorer cognitive skills, either overtly or covertly, when cognitively tested. Cognitive changes reflect, tumour mass, fronto-temporal location or hydrocephalus, Previous work has demonstrated that the “semantic Verbal Fluency Test (SVFT) -“How many animals can you think of in a minute?” is a useful fast screening test for cognitive issues. Median SVFT in patients with brain tumour on admission is 10 animals. Most GPs can now order “direct access cerebral imaging (DACI)” in patients with headache suspicious of cancer. The waiting times for scanning can be many weeks. The aim of this study was to determine whether low SVFT scores: might be useful to help stratify or expedite DACI. We present data from referrals through and electronic Protocol Based Referral (PBR) pathway for CT scanning over 3 years, to determine whether SVFT might be a useful adjunct to history and examination. Method From 2017, in Edinburgh/Lothians, Scotland, an electronic PBR was developed with involvement of Primary Care Cancer Lead, PBR lead, Neurology, Neurosurgery and Neuro-Imaging for outpatient imaging of patients in the community with Headache Suspicious of Cancer, to expedite their scans. The PBR sat alongside the routine outpatient DACI system. If the forms were correctly filled in Neuro-Radiology prioritised their appointments. The referrer (GP) was asked to complete the ePBR form and SVFT at the time of referral. Other data were also gathered, including: Past Medical History of cancer; other symptoms/signs; and co-morbid conditions and medications filled automatically from the GP system. This formed the dataset. We also retrospectively assessed a) whether English was first language b) past history of Pain Clinic Attendance or Functional Illness and subsequent final diagnosis of headache/condition, through evaluation of electronic GP referral letters through SCI Gateway system of those cases where SVFT was recorded. Results Between March 2017 - November 2019, 669 scans through PBR pathway. (62% females; Mean age 53 years: 60% cases =17 (35 animals) (0.5%) - CT scan showed small multiple intra-cerebral calcified and non-calcified lesions, consistent with metastases. 12% with PMH cancer had a tumour. Other possible reasons for low SVFT were: co-existing presumed dementia/mild cognitive impairment (19); non native English speakers (12); headache after traumatic brain injury (5); significant small vessel disease/vascular(5); intracranial cysts (4)(pineal / arachnoid, Giant Cell Arteritis (4) (all new - symptomatic); Chiari 1 malformations (2), PMH – encephalitis (1). Interestingly, there were 53 cases with known psychiatric/pain conditions on drugs (e.g. codeine/antidepressants/antipsychotics) with SVFT < 17 words/min. Conclusion People with Headache "Suspicious of Cancer" + SVFT Other probable causes /associations, with SVFT =17 in those with Headache Suspicious of Cancer, does not exclude the possibility of an intracranial tumour. Excluding cases with recognised causes for low SVFT e.g. dementia and those with existing chronic pain/psychiatric disease further increases the likelihood of a secondary cause for headache. SVFT should be tested in the persons native language. A larger prospective study is required to establish whether these pilot study data and to examine whether chronic pain, functional neurology are negative predictive factors for secondary headache.

BACKGROUND Most primary brain tumour patients rely on informal caregivers (i.e. family members or friends) for practical and emotional support. While caregiving can be rewarding, it also commonly leads to significant burden. In developing support for caregivers, it is vital to distinguish between caregivers’ unmet needs, and their actual wish for support to resolve unmet needs. We aimed to 1) identify the presence and magnitude of unmet needs; 2) examine associations between unmet needs and desire for support; 3) evaluate perceived usefulness of caregiver needs screening in clinical practice. MATERIAL AND METHODS Family caregivers of patients with primary brain tumours were recruited and asked to complete an adapted version of the Caregiver Needs Screen (CNS). This covered the level of distress resulting from 33 common issues in neuro-oncology caregiving (scale 0–10), and wish for information or support for any issue (yes/no). In addition, participants were asked to rank (0–7) their experience of using the CNS based on items covering ‘ease of us’, ‘usefulness’ and ‘satisfaction’. Descriptive and correlational analyses were applied. RESULTS Caregivers (N=79) reported between 1–33 unmet needs (M=17.20, sd=7.98) but did not always wish for support for each need (range 0–28, M=4.71, sd=6.63). Most distressing items were patient’s fatigue (M=5.58), recognising signs of disease progression (M=5.23), changes in patients’ thinking or behaviour (M=5.04), patient distress or sadness (M=4.68), and changes in caregivers’ own emotional health (M=4.44). A weak correlation was found between the total number of unmet needs and the desire for support (r=0.296, p=0.014). Caregivers most often desired support with recognising disease progression (N=24), managing medications and side-effects (N=18), and least often with managing spiritual issues (N=0), communication with (grand)children (N=2) and communication with family members and friends (N=3). Caregivers evaluated the CNS tool positively (mean item scores ranging 4.19–6.21 out of 7). CONCLUSION Family caregivers of brain tumour patients experience distress resulting from many neuro-oncology specific needs, but this is not directly related to a wish for support or information. Caregiver needs screening could be useful to tailor support or information to suit caregivers’ preferences in clinical practice.

BACKGROUND Fatigue is common and disabling for brain tumour patients. We studied the feasibility of two innovative lifestyle coaching interventions for high fatigue. METHODS Multi-centre phase II feasibility RCT (ISRCTN17883425). Adult primary brain tumour outpatients reporting significant fatigue (Brief Fatigue Inventory [BFI] score 4+), were randomised to one of three arms: Control; Health Coaching (“HC”, comprising eight structured coaching sessions on lifestyle behaviours); or HC plus Activation Coaching (“HC+AC”, adding two structured interviews targeting motivation to change). Outcomes were measured at baseline (T0), after interventions (T1), and at 16 weeks (T2). The primary outcome of feasibility was required for both recruitment (aim: average n= 5 fatigued patients recruited/month) and retention (aim: minimum 60% retention at T2). Secondary pilot outcomes included change in fatigue, depressive symptom, and QOL measures. RESULTS Over a nine-month recruitment period, n= 46 fatigued brain tumour patients were recruited (average n=5.1/month) and n= 34 were retained to endpoint (retention at T2= 73%), meeting the primary outcome of feasibility. Surprisingly, fatigue reduced significantly after HC (T1 mean change in BFI score from T0 baseline, relative to the equivalent change in control group: HC= -2.3 points [95%CI -3.4/-0.3]; HC+AC= -2.0 [-2.9/+0.1]; ANOVA p= 0.02) and was reduced in magnitude in both intervention groups at T2 (p= N.S). Both interventions also improved depressive symptoms (T1 mean change in HADS-Depression: HC= -2.0 points [-5.6/-0.1]; HC+AC= -2.9 [-6.5/-1.0]; Kruskal-Wallis p= 0.02). Patient-nominated QOL outcomes improved persistently after HC+AC (T2 mean change in PSYCHLOPS score: HC= -2.4 points [-5.4/+2.8]; HC+AC= -6.1 [-9.2/-0.8]; ANOVA p= 0.01). CONCLUSION Innovative coaching interventions, focused on lifestyle factors, are feasible to deliver to fatigued brain tumour patients. Preliminary signals suggest that these non-drug approaches may benefit several mediators of quality of life and warrant further study.

BACKGROUND BT-LIFE is a multi-centre RCT of novel lifestyle coaching treatments for fatigued brain tumour patients. To our knowledge it is also the first example of ‘multi-sectoral research’ to combine healthcare, private, and charity sectors in this population. To maximise learning, the trial team devised a structured reflection opportunity to ask, “What went well and what would we do differently next time?” METHOD After trial closedown we convened a six-hour ‘focus group’ for management, principle investigators, research assistants, interventionists, qualitative researchers, trial statisticians, and the funder. Discussion was structured using a ‘timeline’ wall-chart which attendees freely populated with post-it notes summarising learning points from the trial. Minutes were taken in duplicate. RESULTS In total n=19 team members contributed. Many points were study-specific and will be used internally to plan a larger trial. Among points of wider interest, examples of success included: using regular teleconferences to co-ordinate a cohesive and highly collaborative team; obtaining secure nhs.net email addresses to facilitate multi-sectoral communication; and the clear value of employing one part-time research assistant per centre instead of relying on busy clinical staff to recruit. General future learning points included: speak to the prospective sponsor and ethical committees when writing the grant application to avoid pitfalls and facilitate faster opening if funding is secured; consider preceding emails with a phone call to ‘lay the ground’ in time-sensitive situations; identify staff training requirements as early as possible and cascade aggressively; and be sensitive to the fact that inter-sectoral attitudes and practices may vary widely and need actively monitored and managed. Therefore frequent and secure communication, pro-active problem-spotting, and inter-sectoral value alignment appear critical for success. CONCLUSION BT-LIFE provides many useful lessons for anyone interested in running multi-sectoral research.

BACKGROUND Data on the use of lacosamide (LCM) for the treatment of brain tumor-related epilepsy (BTRE) are limited. The objective of this study was to evaluate the effectiveness and tolerability of LCM added to 1 or 2 antiepileptic drugs (AEDs) in the treatment of patients with epilepsy due to low-grade primary brain tumor. MATERIAL AND METHODS Prospective, multicenter, single-arm, non-interventional study with a 6-month observation period (EP0045; NCT02276053). LCM was added to existing treatment with 1 or 2 AEDs. Patients aged ≥16 years with BTRE secondary to low-grade glioma (WHO Grade I-II) were eligible. Primary endpoints: patients experiencing a ≥50% reduction in seizure frequency from Baseline to Month 6; Patient’s Global Impression of Change (PGIC) rating at Month 6. Secondary endpoints: Kaplan-Meier estimated retention rate and change from Baseline in quality-of-life to Month 6 (EQ-5D-5L and MDASI-BT). Safety variables: occurrence of adverse drug reactions (ADRs) and ADRs leading to discontinuation. The present analysis was performed for the safety set: all patients who took ≥1 dose of lacosamide. RESULTS The study was conducted between November 2014 and December 2017. Patients were enrolled from 24 sites in Italy, the United Kingdom, the Netherlands, Germany, France, and Spain. 93 patients started LCM (mean [SD] age: 44.5 [14.7] years; 50 [53.8%] male); 14 (15.1%) withdrew from the study by 6 months. 85 (91.4%) patients had low-grade glioma, 3 (3.2%) had suspected glioma, 3 (3.2%) had meningioma, 1 (1.1%) had craniopharyngioma, and 1 (1.1%) had a histologically unverified tumor. At 6-months, 66 (71.0%) patients reported a ≥50% reduction in seizure frequency, 30 (32.3%) of whom were seizure-free. Improvements on PGIC were reported by 49 (52.7%) patients. The Kaplan-Meier estimated 6-month retention rate was 86.0%. Quality of life (EQ-5D-5L) and symptoms outcome measures (MDASI-BT) remained stable. ADRs leading to discontinuation occurred in 4 (4.3%) patients, most commonly vertigo (2 [2.2%] patients). CONCLUSION This is the first prospective, multicenter study focusing on epilepsy due to slow-growing tumors (mainly low-grade gliomas), treated with LCM. The results suggest that LCM reduces seizures in patients with resistant BTRE. The majority of patients noticed a clinical improvement with the addition of LCM. Observed ADRs were consistent with the known safety profile of LCM. STUDY SUPPORTED BY: UCB Pharma.

Seizures are a well-recognized symptom of primary brain tumors, and anticonvulsant use is common. This paper provides an overview of epilepsy and the use of anticonvulsants in glioma patients. Overall incidence and mechanisms of epileptogenesis are reviewed. Factors to consider with the use of antiepileptic drugs (AEDs) including incidence during the disease trajectory and prophylaxis along with considerations in the selection of anticonvulsant use (ie, potential side effects, drug interactions, adverse effects, and impact on survival) are also reviewed. Finally, areas for future research and exploring the pathophysiology and use of AEDs in this population are also discussed.

BACKGROUND Glioma patients may experience behavioral and personality changes (BPC), which have a negative impact on the lives of both brain tumor patients and their relatives. The extent of BPC is currently unknown, and it is unclear if available assessment tools cover all aspects of BPC that are relevant for glioma patients. This study aimed to determine which characteristics of BPC are relevant for glioma patients. METHODS Possible characteristics of BPC were identified in the literature and based on expert opinion. Next, these 49 items were presented to patients and caregivers/former caregivers in an online survey launched via the International Brain Tumour Alliance. Participants were requested to indicate the relevance for each characteristic on a 4-point Likert scale ranging from ‘not at all’ to ‘very much’. In addition, they had to indicate which three characteristics had most impact on their daily life, and if characteristics were missing. RESULTS Completed surveys were obtained from 141 respondents, of which 36% were patients, 50% caregivers and 14% unknown. Most patients had grade II or IV glioma (29% vs 38%). Of 49 characteristics, 35 were reported as relevant in at least 25% (range all characteristics: 7–44%). Patients (n=50) and caregivers (n=70) rated different characteristics as most important. Common characteristics were lack of motivation, change in being socially active, not able to finish things and change in level of irritation. There were no characteristics reported to be missing by ≥5 respondents. CONCLUSION The majority of characteristics were rated as relevant in >25% of respondents, and patients and caregivers differed in which were most relevant. A clear definition based on these results is therefore difficult to establish. A next step would be to perform a cluster analysis of patients and caregivers separately, and discuss the results with experts, to reach consensus on an appropriate definition.

BACKGROUND In brain tumour patients, impairments in every day functioning can impact quality of life, and are therefore an important outcome in both clinical trials and practice. One way to measure every day functioning is with an activities of daily living (ADL) questionnaire. Instrumental ADL (IADL) are the cognitively more complex activities, that are essential to function autonomously within society. Cognitive decline may therefore negatively impact IADL, making these activities particularly relevant to brain tumour patients. The aim of this study is to develop a reliable and valid questionnaire to measure IADL in primary malignant and metastatic brain tumour patients. MATERIAL AND METHODS The questionnaire development study followed the standard European Organisation for Research and Treatment of Cancer (EORTC) four phase methodology: (I) generation of activities list, (II) construction of item list, (III) pre-testing, and (IV) field testing. This report covers phases I-III. To ensure cross-cultural validity, participants were recruited from different countries (The Netherlands, United Kingdom, Italy, Austria and Japan). In phase I, potential activities were identified based on a literature review and in-depth interviews with patients, proxies and healthcare professionals. In phase II, activities were turned into items, and translated into all required languages by the EORTC Translation Unit. In phase III, the item list was pre-tested in patient-proxy dyads. In accordance with predetermined decision rules to reduce items, final items were selected, and preliminary psychometric properties (i.e. factor structure, validity, reliability) were assessed. RESULTS Phase I (N=44 dyads) resulted in 59 IADL activities which were converted into 59 items in phase II. In phase III, N=85 dyads completed and reviewed this item list. The item list was subsequently reduced to 32 items. An exploratory factor analysis indicated several items measuring similar underlying constructs (e.g. domestic life and using computer/smartphone) showing acceptable to good (α≥0.7) internal consistency (range α=0.69–0.89). Seven items were less related to these underlying constructs (e.g. work or managing your own medication), and therefore single items. Construct validity, measured with known-group comparisons analyses between cognitively impaired and unimpaired patients, showed significant differences in scores between the two groups on some scales and several single items. CONCLUSION The currently developed EORTC IADL-BN32 questionnaire can be a valuable asset in assessing IADL functioning in brain tumour patients, but further validation in phase IV is required and is planned.

No depression screening tool is validated for use in cases of cerebral glioma. To address this, we studied the operating characteristics of the Hospital Anxiety and Depression Scale (Depression subscale) (HAD-D), the Patient Health Questionnaire-9 (PHQ-9), and the Distress Thermometer (DT) in glioma patients.We conducted a twin-center prospective observational cohort study of major depressive disorder (MDD), according to the Diagnostic and Statistical Manual, 4th edition, in adults with a new diagnosis of cerebral glioma receiving active management or "watchful waiting." At each of 3 interviews over a 6-month period, patients completed the screening questionnaires and received a structured clinical interview to diagnose MDD. Internal consistency, area under the receiver operating characteristics curve (AUC), sensitivity, specificity, positive predictive value, and positive likelihood ratio were calculated. A maximum of 154 patients completed the DT, 133 completed the HAD-D, and 129 completed the PHQ-9. The HAD-D and PHQ-9 showed good internal consistency (α ≥ 0.77 at all timepoints). Median AUCs were 0.931 ± 0.074 for the HAD-D and 0.915 ± 0.055 for the PHQ-9. The optimal threshold was 7+ for the HAD-D, but 8+ had similar operating characteristics. There was no consistently optimal PHQ-9 threshold, but 10+ was optimal in the largest sample. The DT was inferior to the multi-item instruments. Clinicians can screen for depression in well-functioning glioma patients using the HAD-D at the existing recommended lower threshold of 8+, or the PHQ-9 at a threshold of 10+. Due to a modest positive predictive value of either instrument, patients scoring above these thresholds need a clinical assessment to diagnose or exclude depression.

Patients with brain tumors often have subtle cognitive change, which may go unnoticed by patient and family doctor. This may result in delays in diagnosis. We studied the relationship between first and subsequent symptoms and semantic verbal fluency test (SVFT), a quick cognitive screening test. (Normal median SVFT for 60–79 age range who have 12 years of education = 17 animals; 10th percentile is 12 animals). Patients with new intrinsic brain tumors had structured patient interviews to determine first and subsequent symptoms. Patients were specifically asked about cognition. A cognitive screening test (SVFT – how many animals can you think of in a minute) was performed in patients as part of the Addenbrookes Cognitive Exam on admission. Symptoms were categorized into focal, non-focal, episodic attack or headache. 127 patients with cerebral brain tumors were assessed– glioma (n=94 HGG=79;LGG=15); metastasis (n= 28); primary CNS lymphoma (n=5). Mean age, 56.2, (SD 13.1): 55% male. 16 patients presented with a solitary symptom (episodic (9); focal (4); headache (3); non-focal (0)). As symptoms accumulated time to diagnosis increased “1 symptom” (med 23 days); “2 symptoms” (med 42 days) “>=3 symptoms” (med 44 days). Mean SVFT was lowest in HGG (mean 10.9) vs LGG (mean 15.7). Patient awareness of cognitive problems did not correlate with SVFT score (aware (n=50) mean 11.9 v unaware (n=77) mean 11.7)) Presentation with an isolated cognitive complaint is uncommon in cerebral brain tumors. Diagnosis becomes apparent when combined with headache or focal symptoms. Diagnosis becomes easier when multiple symptoms accumulate, but there are increasing delays. Many patients with headache also have asymptomatic cognitive problems on SVFT. Where there is a suspicion of cerebral problem e.g. headache suspicious of cancer, it is insufficient just to ask patients whether they have cognitive problems. SVFT may be a helpful red flag.

Guidance to General Practitioners on referral for direct-access brain imaging, based on levels of risks for CNS malignancy (red/orange/yellow) are proposed. However, the effect of such guidance upon referral behaviour is unknown.

Seizures are a well-recognized symptom of primary brain tumors, and anticonvulsant use is common. This paper provides an overview of epilepsy and the use of anticonvulsants in glioma patients. Overall incidence and mechanisms of epileptogenesis are reviewed. Factors to consider with the use of antiepileptic drugs (AEDs) including incidence during the disease trajectory and prophylaxis along with considerations in the selection of anticonvulsant use (ie, potential side effects, drug interactions, adverse effects, and impact on survival) are also reviewed. Finally, areas for future research and exploring the pathophysiology and use of AEDs in this population are also discussed.

INTRODUCTION: Early diagnosis of brain tumours is one of the top 10 clinical research priorities identified by the neuro-oncology community. Headache is the most common first symptom (23%), is present in 50% by the time of initial hospital attendance and presentations are often delayed. Patients with tumour associated headaches often have unrecognised, or subtle, visual or cognitive signs or changes in behaviour/mood - headache “plus”. These cases often have a delayed presentation to primary care, when compared with patients presenting with focal symptoms or signs (e.g. hemiparesis, dysphasia) or seizures. We have used prospective national and local audit findings and stakeholder consensus to produce a Lothian electronic Protocol Based Referral for expedited GP open access brain CT imaging or referral for fast Optometry assessment within 24–48 hours. METHODS: Data form over 340 brain tumour patients involved in a Scottish audit of first presenting symptom and symptoms and signs at ­hospital presentation and neuro-cognitive data from 100 patients admitted for surgery with a brain tumour, were evaluated, looking at diagnostic delays and subtle finding found in patients presenting with headache as an early symptom. The Edinburgh Protocol was developed in collaboration with Macmillan Lead Cancer GP, Lead GP for Protocol Based Referral (PBR), Secondary Care Neuroscience specialists and the Scottish Lead for Optometry. Using the established Lothian GP Open Access CT scan policy and the Lothian electronic referral system for referral for scanning supplemented by the RefHelp system for GPs a new expedited PBR for 24–48 hour imaging and optometry evaluation was agreed. RESULTS: The Edinburgh Protocol for “Headache Plus” suspicion of cancer incorporates Scottish Cancer Referral Guidelines for Headache Suspicious of Cancer and co-existence of subtle behavioural or cognitive symptoms; a past history of cancer; or possible visual signs for fast referral for detailed optometry within 24–48 hours for evaluation of visual fields and fundi. Evaluation of a simple fast screening test of cognition (semantic verbal fluency (animals) that can be done in the GP clinic in 2–3 minutes is also being trialled. These features have been integrated into the electronic GP Protocol Based Referral pathway for open access CT brain scan within 24–48 hours rather than the neurological referral for clinical evaluation, usually “2 week wait”. The PBR includes detailed advice in the GP RefHelp system supported by educational videos on headaches and papilloedema and how to perform the semantic verbal fluency test. CONCLUSION: The Edinburgh Protocol for “Headache Plus” suspicion of cancer PBR is currently being trialled in Lothian Region, Scotland. The detailed evaluation including; referral times, frequency of positive scans, before and after comparisons with referral times in Lothian and impact on existing open access CT scanning numbers and waiting times are being assessed as part of a Brain Tumour Charity Grant for “Diagnosing Brain Tumours Earlier” programme.

BACKGROUND: Fatigue is the most common symptom reported by primary brain tumour patients; causes are multi-factorial. The aim of the study was to further explore fatigue in relation to co-occurring symptoms. METHODS: A single-centre cross-sectional prospective study design was used. Inclusion criteria were: histological diagnosis of a primary brain tumour, ≥ 18 years, stable disease, able to provide informed consent, and treatment-free for 3 months prior to participation. NHS ethical approval was obtained. Objective and subjective measures were used to assess fatigue (BFI), cognition (HVLT-R, COWA, Trail Making Test, IQ), sleep (Actigraphy, Epworth Sleepiness Scale), mood (HADS) and physical function (EDSS, nine hole peg test, 10m walk). RESULTS: Eighty-five patients with a primary brain tumour were recruited; 16% reported severe fatigue (Mage = 49.8, SD = 13.3), 48% reported moderate fatigue (Mage = 48.3, SD = 9.6), 33% reported mild fatigue (Mage = 46.9, SD = 12.1). Fatigue severity was significantly positively related to anxiety (p = 0.008), depression (p =< 0.0001), daily activity percentage (p = 0.035), information processing speed (p = 0.0006), physical impairment (p =< 0.0001) and the use of non-enzyme inducing anti-epileptic drugs (p = 0.011). Using multivariate logistic regression, physical function (p = 0.0003) and anxiety (p = 0.017) were found to be independent predictors of fatigue. CONCLUSIONS: Fatigue continues to be prevalent in primary brain tumour patients. As previously found, fatigue co-occurs with other symptoms. Physical disability and anxiety predict fatigue. Screening for fatigue and other symptoms may help to determine avenues for physical interventions and/or psychological interventions.

INTRODUCTION: Fatigue is unusual daytime tiredness not relieved by sleep. It is common and with mixed aetiology in glioma. Annual fatigue assessment in stable patients with glioma is being trialled through a ‘symptoms MDM’ METHOD: Patients aged >18years, diagnosed with a glioma that was clinically stable, and had completed a fatigue study, were offered further clinical evaluation of their results by discussion at a ‘symptoms MDM’. This included a neurologist, clinical psychologist, psychiatrist and sleep consultant. Assessments included self-reported fatigue, mood, cognition, a growth hormone questionnaire, full neurological examination, and 2 week sleep assessment using an Actigraphy Watch and sleep log. RESULTS: 37/50 patients requested further assessment, including 10/10 severely fatigued, 22/24 moderately fatigued, 4/8 mildly fatigued and 1/8 non-fatigued. Of these the HADS depicted 20 patients with abnormal anxiety (8 borderline) and 5 with abnormal depression (11 borderline), 36 had poor cognition in one or more areas, and a sleep consultant reviewed 23 with abnormal sleep.Individual intervention plans included combinations of: referrals to clinical psychology (10), psychiatry (2), endocrinology (17), sleep clinic (5) and anti-epileptic medication review (9). Twelve were offered local support group in formation, and 24 were offered self-guided relaxation and sleep hygiene information. Almost all patients agreed to all interventions; 1 declined clinical psychology referral, 3 declined anti-epileptic review due to regaining a driving licence. CONCLUSION: Fatigue in glioma is common, complex and debilitating, but may be helped by managing symptoms, through annual ‘symptoms MDM’ and individualised treatment plans.

INTRODUCTION: Little is known about Health-Related Quality of Life of glioma patients during the end-of-life-phase of care. During this time, patients may experience a number of neurological and cognitive deficits, changes in personality, epilepsy, side-effects of medication, fatigue and depression. To explore this, carer perceptions of the level of disability and quality of care in the end of life phase of patients with high grade glioma were explored at 3 months and 1 week before the death of the patient. METHODS: A retrospective descriptive study of General Practitioners (GP) and relatives of deceased patients diagnosed between 2008 and 2009 was carried out in South East Scotland. Questionnaires relating to symptoms, quality of life, health care provision, place of care, patient's wishes and end-of-life care were sent to GPs and relatives following the death. Patient demographics and tumour details were extracted from case records where available. RESULTS: 110 relatives were sent questionnaires 52 (46%) relatives responded. Relatives stated that at 3 months headache was the most reported symptom (56%), followed by seizures (40%) and hemiparesis (29%), whereas at 1 week prior to death, fatigue was the most common symptom (71%), followed by nausea/vomiting (63%) and confusion (42%). Eighty percent of patients used a stick, or were wheelchair or bedbound at 3 months whereas, 90% were confined to their bed and 94% required assistance 1 week prior to death Approximately 1 in five patients had seizures at least weekly at 3 months and also in the last week of life. Main issues that affected dignity of death included communication problems (50%) cognitive issues (44%) or inability to care for themselves. Sixty two percent of relatives felt that symptoms were treated effectively. Most relatives felt they had enough information provided by the health care professionals (86%), that they were involved in decision making (92%), and agreed with the decisions made (84.5%). Further, only 14% were dissatisfied with their role as caregiver at the end of life, but more than half felt there was insufficient psychological support for them. Thirty seven percent of patients had a living will and in the last week the majority of patients did not have capacity. Overall, 20 (38%) patients died in hospice; 17 (33%) died at home; 12 (23%) died in hospital; 2(4%) died in a nursing home and 1(2%) died elsewhere. CONCLUSIONS: Most relatives were satisfied with both their role as caregiver, and the involvement in decision making about the patient's care. Advanced care planning needs to be encouraged early in the disease process. Relatives felt that there was scope for better symptom control and there was insufficient psychological support for themselves.