A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial.

BACKGROUND: Glioblastoma (GBM) is the most common adult malignant brain tumour, with an incidence of 5 per 100,000 per year in England. Patients with tumours showing O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation represent around 40% of newly diagnosed GBM. Relapse/tumour recurrence is inevitable. There is no agreed standard treatment for patients with GBM, therefore, it is aimed at delaying further tumour progression and maintaining health-related quality of life (HRQoL). Limited clinical trial data exist using cannabinoids in combination with temozolomide (TMZ) in this setting, but early phase data demonstrate prolonged overall survival compared to TMZ alone, with few additional side effects. Jazz Pharmaceuticals (previously GW Pharma Ltd.) have developed nabiximols (trade name Sativex®), an oromucosal spray containing a blend of cannabis plant extracts, that we aim to assess for preliminary efficacy in patients with recurrent GBM. METHODS: ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to assess cannabinoids in patients with recurrent MGMT methylated GBM who are suitable for treatment with TMZ. Patients who have relapsed ≥ 3 months after completion of initial first-line treatment will be randomised 2:1 to receive either nabiximols or placebo in combination with TMZ. The primary outcome is overall survival time defined as the time in whole days from the date of randomisation to the date of death from any cause. Secondary outcomes include overall survival at 12 months, progression-free survival time, HRQoL (using patient reported outcomes from QLQ-C30, QLQ-BN20 and EQ-5D-5L questionnaires), and adverse events. DISCUSSION: Patients with recurrent MGMT promoter methylated GBM represent a relatively good prognosis sub-group of patients with GBM. However, their median survival remains poor and, therefore, more effective treatments are needed. The phase II design of this trial was chosen, rather than phase III, due to the lack of data currently available on cannabinoid efficacy in this setting. A randomised, double-blind, placebo-controlled trial will ensure an unbiased robust evaluation of the treatment and will allow potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development. TRIAL REGISTRATION: ISRCTN: 11460478. CLINICALTRIALS: Gov: NCT05629702.

Living with an artificial eye: qualitative insights into patient and family member experiences.

PURPOSE: Artificial eye users (AEUs) can experience a negative impact on psychological and emotional wellbeing, including reduced social functioning, which may be a consequence of living with one eye removed, and/or of having a prosthetic eye. This may have wider consequences for their families. We aimed to explore what it means to live with a prosthetic eye, for both AEUs and their families-and how any quality of life (QoL) issues impact on their day-to-day functioning. METHODS: A subset of AEUs and their family members taking part in a feasibility randomised controlled trial comparing hand-painted to digitally printed artificial eyes were invited for semi-structured interviews. Transcripts were analysed using reflexive thematic analysis. Qualitative results related to trial participation are covered elsewhere. Here, we focus on QoL and day-to-day functioning. RESULTS: Twelve AEUs (eight males) and five spouses (one male) who had worn artificial eyes for 2-65 years took part, and four themes were identified. (1) Impact on day-to-day life: AEUs and their spouses have to adapt to (partial) sight loss, reduced levels of confidence, and social withdrawal. (2) Impact on psychological and emotional wellbeing: distress among AEUs and their spouses can be severe and prolonged, highlight unmet support needs. (3) Challenges with treatment experiences: AEUs experienced negative impact of fragmentation of care and long waiting times. (4) Worries about the future: AEUs mentioned fragility of remaining sight, and concerns around potential need for further treatment. CONCLUSION: Patients and their family members experience negative impact of being an AEU on their everyday lives and quality of life. There is a potential role for psychosocial support services in supporting AEUs and their families even long after eye loss.

The experience of interval scans for adults living with primary malignant brain tumors.

PURPOSE: People with primary malignant brain tumors (PMBT) undergo anti-tumor treatment and are followed up with MRI interval scans. There are potential burdens and benefits to interval scanning, yet high-quality evidence to suggest whether scans are beneficial or alter outcomes of importance for patients is lacking. We aimed to gain an in-depth understanding of how adults living with PMBTs experience and cope with interval scanning. METHODS: Twelve patients diagnosed with WHO grade III or IV PMBT from two sites in the UK took part. Using a semi-structured interview guide, they were asked about their experiences of interval scans. A constructivist grounded theory approach was used to analyze data. RESULTS: Although most participants found interval scans uncomfortable, they accepted that scans were something that they had to do and were using various coping methods to get through the MRI scan. All participants said that the wait between their scan and results was the most difficult part. Despite the difficulties they experienced, all participants said that they would rather have interval scans than wait for a change in their symptoms. Most of the time, scans provided relief, gave participants some certainty in an uncertain situation, and a short-term sense of control over their lives. CONCLUSION: The present study shows that interval scanning is important and highly valued by patients living with PMBT. Although interval scans are anxiety provoking, they appear to help people living with PMBT cope with the uncertainty of their condition.

Communication in the context of glioblastoma treatment: A qualitative study of what matters most to patients, caregivers and health care professionals.

BACKGROUND: Patients with glioblastoma have a poor prognosis and treatment is palliative in nature from diagnosis. It is therefore critical that the benefits and burdens of treatments are clearly discussed with patients and caregivers. AIM: To explore experiences and preferences around glioblastoma treatment communication in patients, family caregivers and healthcare professionals. DESIGN: Qualitative design. A thematic analysis of semi-structured interviews. SETTING/PARTICIPANTS: A total of 15 adult patients with glioblastoma, 13 caregivers and 5 healthcare professionals were recruited from Leeds Teaching Hospitals NHS Trust. RESULTS: Four themes were identified: (1) Communication practice and preferences. Risks and side-effects of anti-tumour treatments were explained clearly, with information layered and repeated. Treatment was often understood to be 'the only option'. Understanding the impact of side-effects could be enhanced, alongside information about support services. (2) What matters most. Patients/caregivers valued being well-supported by a trusted treatment team, feeling involved, having control and quality of life. Healthcare professionals similarly highlighted trust, maintaining independence and emotional support as key. (3) Decision-making. With limited treatment options, trust and control are crucial in decision-making. Patients ultimately prefer to follow healthcare professional advice but want to be involved, consider alternatives and voice what matters to them. (4) Impact of COVID-19. During the pandemic, greater efforts to maintain good communication were necessary. Negative impacts of COVID-19 were limited, caregivers appeared most disadvantaged by pandemic-related restrictions. CONCLUSIONS: In glioblastoma treatment communication, where prognosis is poor and treatmentwill not result in cure, building trusting relationships, maintaining a sense of control and being well-informed are identified as critical.

Healthcare professional experiences of making surgical oncology decisions and delivering COVID-19 safe care: a qualitative study.

BACKGROUND: The COVID-19 pandemic was declared a public health emergency in March 2020. The British National Health Service (NHS) redirected medical attention towards prioritising COVID-19-positive patients in favour of less urgent care affecting cancer service provision. This study aims to explore experiences of healthcare professionals (HCPs) and investigate the impact of COVID-19 on decision-making in surgical oncology. METHODS: HCPs with experience in surgical oncology were recruited from January 2021 to June 2021. Qualitative semi-structured telephone interviews were conducted and transcribed verbatim. Interviews were conducted until data saturation. Thematic analysis was used to identify frequently discussed themes. RESULTS: A total of 13 participants were interviewed, identifying three main pandemic-related challenges: multi-disciplinary team (MDT) processes - telephone pre-operative assessments impoverished information elicited from in-person examination; service delivery - personal protective equipment (PPE) added complexity to surgical practice and more difficult communication; work routines - increased workload to deliver COVID-safe remote practices and decreased training time. CONCLUSIONS: COVID-19 influenced cancer service provision with teams making significant changes to ensure that effective clinical reasoning and surgical standards were maintained. Managing safe COVID-19 surgical care impacted daily-life and work stressors. Post crisis, service delivery is looking to integrate telemedicine within care whilst reducing its impact on workload and in-practice training.

Long-term unmet supportive care needs of teenage and young adult (TYA) childhood brain tumour survivors and their caregivers: a cross-sectional survey.

INTRODUCTION: The supportive care needs of long-term childhood brain tumour survivors, now teenagers and young adults (TYAs), and their caregivers are largely unknown. We aimed to describe their supportive care needs and explore associations between needs and quality of life (QoL). METHODS: Participants were recruited from long-term follow-up clinics (in three NHS Trusts in England) and online. Participants included childhood brain tumour survivors, ≥ 5 years from diagnosis, currently aged 13-30, and their primary caregivers. Survivors completed the Supportive Care Needs Survey (SCNS) Short Form and caregivers the SCNS-Partners & Caregivers, alongside validated QoL questionnaires (Peds-FACT-Br and CQOLC). RESULTS: In total, 112 individuals (69 survivors/43 caregivers) participated. Survivors reported on average 9.4 (± 8.5) unmet needs. Needs were greatest in the psychological domain, with anxiety (60.3%), uncertainty about the future (50.7%) and feeling down and depressed (48.5%) most commonly reported. Caregivers reported on average 12.4 (± 12.3) unmet needs. Again, the greatest number of unmet needs was observed in the psychological domain. Many caregivers also reported information needs around financial support/government benefits (42.9%) and possible survivor fertility problems (42.9%). Multivariable linear regression analysis showed that female survivors, unemployed survivors, survivors further away from diagnosis and single caregivers were more likely to report unmet needs. More unmet needs were significantly associated with poorer QoL in survivors and caregivers. CONCLUSION: This research provides leads to improving supportive care and long-term follow-up services. Psychological support represents the biggest gap in care. Understanding unmet needs and recognising what services are required are critical to improving quality of long-term survival.

The effects of SmartCare© on neuro-oncology family caregivers' distress: a randomized controlled trial.

PURPOSE: Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS: Family caregivers scoring ≥ 6 on a depressive symptoms inventory were randomized to three groups: ECAU plus self-guided CBT and SmartCare©; ECAU plus SmartCare©; ECAU only. Primary outcomes (depressive symptoms; caregiving-specific distress) and secondary outcomes (anxiety, caregiver mastery, and caregiver burden) were assessed online. Intention to treat (ITT) and per protocol (PP) analyses of covariance corrected for baseline scores were performed for outcomes at 4 months. RESULTS: In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n = 80) and compared to ECAU (n = 40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (ITT: p = 0.01, partial ɳ2 = 0.08; PP: p = 0.02, partial ɳ2 = 0.08). A trend towards improvement in mastery for the intervention group compared with ECAU was identified (ITT: p = 0.08, partial ɳ2 = 0.04; PP: p = 0.07, partial ɳ2 = 0.05). CONCLUSIONS: SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis. TRIAL REGISTRATION NUMBER: NCT02058745; 10 February 2014.

Determinants and predictors for the long-term disease burden of intracranial meningioma patients.

INTRODUCTION: Meningioma is a heterogeneous disease and patients may suffer from long-term tumor- and treatment-related sequelae. To help identify patients at risk for these late effects, we first assessed variables associated with impaired long-term health-related quality of life (HRQoL) and impaired neurocognitive function on group level (i.e. determinants). Next, prediction models were developed to predict the risk for long-term neurocognitive or HRQoL impairment on individual patient-level. METHODS: Secondary data analysis of a cross-sectional multicenter study with intracranial WHO grade I/II meningioma patients, in which HRQoL (Short-Form 36) and neurocognitive functioning (standardized test battery) were assessed. Multivariable regression models were used to assess determinants for these outcomes corrected for confounders, and to build prediction models, evaluated with C-statistics. RESULTS: Data from 190 patients were analyzed (median 9 years after intervention). Main determinants for poor HRQoL or impaired neurocognitive function were patients' sociodemographic characteristics, surgical complications, reoperation, radiotherapy, presence of edema, and a larger tumor diameter on last MRI. Prediction models with a moderate/good ability to discriminate between individual patients with and without impaired HRQoL (C-statistic 0.73, 95% CI 0.65 to 0.81) and neurocognitive function (C-statistic 0.78, 95%CI 0.70 to 0.85) were built. Not all predictors (e.g. tumor location) within these models were also determinants. CONCLUSIONS: The identified determinants help clinicians to better understand long-term meningioma disease burden. Prediction models can help early identification of individual patients at risk for long-term neurocognitive or HRQoL impairment, facilitating tailored provision of information and allocation of scarce supportive care services to those most likely to benefit.

Unmet support needs in teenage and young adult childhood brain tumour survivors and their caregivers: "it's all the aftermath, and then you're forgotten about".

PURPOSE: Teenage and young adult (TYA) survivors of childhood brain tumours and their family caregivers can experience many late effects of treatment that can hamper the transition to living independent lives. Yet, their long-term supportive care needs are largely unknown. We investigated the supportive care needs of TYA survivors and their caregivers and explored the role and perceived use of support. METHODS: Face-to-face semi-structured interviews were conducted with survivors aged 16-30 (n = 11) who were ≥ 5 years after diagnosis and caregivers (n = 11). Interviews were recorded and transcriptions thematically analysed. RESULTS: Four themes emerged: (1) preferences for support and support services (unmet needs). Concerns regarding mental health, employment and financial uncertainty, the desire to live independently, and lack of support were emphasised. (2) Decline in support. Caregivers noted a drop-off in support available when transitioning to adult services. (3) Reasons for not obtaining adequate support. Several barriers to accessing support were raised, including distance and aging out of services. (4) The role of long-term hospital-based follow-up care. Participants highlighted the importance of, and reassurance from, long-term follow-up care but noted a more all-inclusive approach is required. CONCLUSIONS: Even many years after diagnosis, TYA childhood brain tumour survivors and their caregivers continue to have unmet supportive care needs. Both TYA survivors and their caregivers can benefit from support to meet their unique needs and improve long-term quality of life. Understanding unmet needs and recognising what services are required due to the late effects of treatment is critical to improving long-term quality of survival.

Development of an EORTC questionnaire measuring instrumental activities of daily living (IADL) in patients with brain tumours: phase I-III.

PURPOSE: Being able to function independently in society is an important aspect of quality of life. This ability goes beyond self-care, requires higher order cognitive functioning, and is typically measured with instrumental activities of daily living (IADL) questionnaires. Cognitive deficits are frequently observed in brain tumour patients, however, IADL is almost never assessed because no valid and reliable IADL measure is available for this patient group. Therefore, this measure is currently being developed. METHODS: This international multicentre study followed European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group module development guidelines. Three out of four phases are completed: phases (I) generation of items, (II) construction of the item list, and (III) pre-testing. This paper reports the item selection procedures and preliminary psychometric properties of the questionnaire. Brain tumour patients (gliomas and brain metastases), their informal caregivers, and health care professionals (HCPs) were included. RESULTS: Phase I (n = 44 patient-proxy dyads and 26 HCPs) generated 59 relevant and important activities. In phase II, the activities were converted into items. In phase III (n = 85 dyads), the 59 items were pre-tested. Item selection procedures resulted in 32 items. Exploratory factor analysis revealed a preliminary dimensional structure consisting of five scales with acceptable to excellent internal consistency (α = 0.73-0.94) and two single items. For three scales, patients with cognitive impairments had significantly more IADL problems than patients without impairments. CONCLUSION: A phase IV validation study is needed to confirm the psychometric properties of the EORTC IADL-BN32 questionnaire in a larger international sample.

The role, impact, and support of informal caregivers in the delivery of palliative care for patients with advanced cancer: A multi-country qualitative study.

BACKGROUND: Cancer is increasing in its prevalence in sub-Saharan Africa. Informal caregivers are key to supporting engagement and interaction with palliative care services, but limited literature on their role impedes development of supportive interventions. AIM: We aimed to understand the role, impact, and support of informal caregivers of patients with advanced cancer when interacting with palliative care services in Nigeria, Uganda, and Zimbabwe. DESIGN: Secondary analysis of qualitative interview transcripts. The dataset was assessed for fit and relevance and framework approach was used. SETTING/PARTICIPANTS: Interview transcripts of informal caregivers included participants aged over 18 years of age recruited from palliative care services across participating countries. RESULTS: A total of 48 transcripts were analyzed. Mean age was 37 (range 19-75) with equal numbers of men and women. Five themes emerged from the data: (1) caregivers are coordinators of emotional, practical, and health service matters; (2) caregiving comes at a personal social and financial cost; (3) practical and emotional support received and required; (4) experience of interacting and liaising with palliative care services; and (5) barriers and recommendations relating to the involvement of palliative care. CONCLUSIONS: The role of informal caregivers is multi-faceted, with participants reporting taking care of the majority of medical, physical, financial, and emotional needs of the care recipient, often in the face of sacrifices relating to employment, finances, and their own health and social life. Efforts to develop comprehensive cancer control plans in sub-Saharan Africa must take account of the increasing evidence of informal caregiver needs.

Healthcare utilization and productivity loss in glioma patients and family caregivers: the impact of treatable psychological symptoms.

BACKGROUND: Gliomas are associated with significant healthcare burden, yet reports of costs are scarce. While many costs are unavoidable there may be treatable symptoms contributing to higher costs. We describe healthcare and societal costs in glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms. METHODS: Data from a multicenter randomized trial on effects of internet-based therapy for depressive symptoms were used (NTR3223). Costs of self-reported healthcare utilization, medication use, and productivity loss were calculated for patients and caregivers separately. We used generalized linear regression models to predict costs with depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression), and intervention (use/non-use) as predictors. RESULTS: Multiple assessments from baseline through 12 months from 91 glioma patients and 46 caregivers were used. Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers. In patients, higher healthcare utilization costs were associated with more depressive symptoms; higher medication costs were associated with active/progressive disease. In caregivers, higher overall costs were linked with increased caregiver fatigue, cognitive complaints, and lower patient tumor grade. Higher healthcare utilization costs were related to more cognitive complaints and lower tumor grade. More productivity loss costs were associated with increased fatigue (all P < 0.05). CONCLUSIONS: There are substantial healthcare and societal costs for glioma patients and caregivers. Associations between costs and treatable psychological symptoms indicate that possibly, adequate support could decrease costs. TRIAL REGISTRATION: Netherlands Trial Register NTR3223.

Pharmacological treatment of depression in people with a primary brain tumour.

BACKGROUND: This is the second updated version of the Cochrane Review published in Issue 3, 2010 and first updated in Issue 5, 2013. People with a primary brain tumour often experience depression, for which drug treatment may be prescribed. However, they are also at high risk of epileptic seizures, cognitive impairment, and fatigue, all of which are potential adverse side effects of antidepressants. The benefit, or harm, of pharmacological treatment of depression in people with a primary brain tumour is unclear. OBJECTIVES: To assess the benefits and harms of pharmacological treatment of depression in people with a primary brain tumour. SEARCH METHODS: We updated the search to include CENTRAL, MEDLINE, Embase, and PsycINFO to September 2019. As in the original review, we also handsearched Neuro-Oncology, Journal of Neuro-Oncology, Journal of Neurology, Neurosurgery and Psychiatry, and Journal of Clinical Oncology: for the current update we handsearched the latest three years of articles from these journals (up to November 2019). SELECTION CRITERIA: We searched for all randomised controlled trials (RCTs), controlled clinical trials, cohort studies, and case-control studies of any pharmacological treatment of depression in people with a histologically diagnosed primary brain tumour. DATA COLLECTION AND ANALYSIS: No studies met the inclusion criteria. MAIN RESULTS: We found no eligible studies evaluating the benefits of any pharmacological treatment of depression in people with a primary brain tumour. AUTHORS' CONCLUSIONS: We identified no high-quality studies that investigated the value of pharmacological treatment of depression in people with a primary brain tumour. RCTs and detailed prospective studies are required to inform the effective pharmacological treatment of this common and important complication of brain tumours. Since the last version of this review none of the related new literature has provided additional information to change these conclusions.

Long-term issues and supportive care needs of adolescent and young adult childhood brain tumour survivors and their caregivers: A systematic review.

OBJECTIVE: Long-term issues following diagnosis and treatment of a childhood brain tumour often become apparent as the survivor enters adolescence and young adulthood. Their caregivers may additionally face long-term impacts on their emotional and psychological functioning. This review synthesised evidence on the issues and supportive care needs of adolescent and young adult (AYA) survivors of a brain tumour diagnosed in childhood and their caregivers. METHODS: Electronic databases were searched up until September 2017. All studies reporting on issues or needs of childhood brain tumour survivors (aged 14-39) and their caregivers were included. Narrative synthesis methods were used to summarise, integrate, and interpret findings. RESULTS: Fifty-six articles (49 studies) met the inclusion criteria. Social issues (ie, isolation and impaired daily functioning) were most commonly reported by survivors, followed by cognitive (ie, impaired memory and attention) and physical issues (ie, endocrine dysfunctions and fatigue). Survivors experienced poorer social functioning and sexual functioning and were less likely to be employed or have children, when compared with other AYA cancer survivors. Caregivers experienced reduced support as the survivor moved into young adulthood. Caregivers reported uncertainty, increased responsibilities, and problems maintaining their own self-well-being and family relationships. Few studies reported on supportive care needs. Survivors expressed a need for better educational support and age-specific psychosocial services. CONCLUSIONS: Surviving a childhood brain tumour can be particularly challenging for AYA survivors and their caregivers. Robust structured research is needed to identify specific support needs of both survivors and their caregivers and how these can be optimally addressed.

Interventions to help support caregivers of people with a brain or spinal cord tumour.

BACKGROUND: The diagnosis and treatment of a brain or spinal cord tumour can have a huge impact on the lives of patients and their families with family caregiving often resulting in considerable burden and distress. Meeting the support needs of family caregivers is critical to maintain their emotional and physical health. Although support for caregivers is becoming more widely available, large-scale implementation is hindered by a lack of high-quality evidence for its effectiveness in the neuro-oncology caregiver population. OBJECTIVES: To assess the effectiveness of supportive interventions at improving the well-being of caregivers of people with a brain or spinal cord tumour. To assess the effects of supportive interventions for caregivers in improving the physical and emotional well-being of people with a brain or spinal cord tumour and to evaluate the health economic benefits of supportive interventions for caregivers. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE via Ovid, and Embase via Ovid. We also handsearched relevant published conference abstracts (previous five years), publications in the two main journals in the field (previous year), searched for ongoing trials via ClinicalTrials.gov, and contacted research groups in the field. The initial search was in March 2017 with an update in August 2018 (handsearches completed in January 2019). SELECTION CRITERIA: We included all randomised controlled trials (RCTs) where caregivers of neuro-oncology patients constituted more than 20% of the sample and which evaluated changes in caregiver well-being following any supportive intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and carried out risk of bias assessments. We aimed to extract data on the outcomes of psychological distress, burden, mastery, quality of patient-caregiver relationship, quality of life, and physical functioning. MAIN RESULTS: In total, the search identified 2102 records, of which we reviewed 144 in full text. We included eight studies. Four interventions focused on patient-caregiver dyads and four were aimed specifically at the caregiver. Heterogeneity of populations and methodologies precluded meta-analysis. Risk of bias varied, and all studies included only small numbers of neuro-oncology caregivers (13 to 56 participants). There was some evidence for positive effects of caregiver support on psychological distress, mastery, and quality of life (low to very low certainty of evidence). No studies reported significant effects on caregiver burden or quality of patient-caregiver relationship (low to very low certainty of evidence). None of the studies assessed caregiver physical functioning. For secondary outcomes (patient emotional or physical well-being; health economic effects), we found very little to no evidence for the effectiveness of caregiver support. We identified five ongoing trials. AUTHORS' CONCLUSIONS: The eight small-scale studies included employed different methodologies across different populations, with low certainty of evidence overall. It is not currently possible to draw reliable conclusions regarding the effectiveness of supportive interventions aimed at improving neuro-oncology caregiver well-being. More high-quality research is needed on support for family caregivers of people diagnosed, and living, with a brain or spinal cord tumour.

Discussing factors associated with quality of life in cancer follow-up appointments: a preliminary test of a pragmatic model for clinical practice.

OBJECTIVE:: The aim of this study is to perform a preliminary test of a practical, evidence-based model to enable discussions around quality of life-related concerns during cancer follow-up appointments. DESIGN:: Cross-sectional study measuring quality of life, illness perceptions, emotional distress, fatigue, and subjective cognitive complaints. SETTING:: Cancer outpatient follow-up clinics in four National Health Services in the United Kingdom. PARTICIPANTS:: Working-age post-treatment cancer patients, treated with curative intent. INTERVENTIONS:: Not applicable. MAIN MEASURES:: European Organisation for the Research and Treatment of Cancer - Quality of Life Questionnaire - Core 30, Illness Perceptions Questionnaire - Revised, Hospital Anxiety and Depression Scale, Chalder Fatigue Scale, and Cognitive Failures Questionnaire. RESULTS:: Fifty-seven cancer patients, with a mean age of 36 years and on average 2.75 years post treatment, returned the completed questionnaires. Anxiety partially mediated the association between subjective cognitive complaints and illness identity (60%) and timeline (25%). Cognitive complaints mediated the relationships between quality of life and anxiety (45%), depression (30%), and fatigue (62%). Depression mediated the relationships between quality of life and illness identity (48%) and timeline (40%). CONCLUSION:: Our study provides a preliminary test of an evidence-based model to help elicit quality of life-related concerns during cancer follow-up appointments. Illness perceptions are associated with quality of life through the mediation of other cancer-relevant factors. Discussing the type, origin, and expected duration of symptoms may elicit other concerns, such as emotional distress, fatigue, or cognitive complaints, which explained a significant amount of the relationship between illness perceptions and quality of life.

Internet-based guided self-help for glioma patients with depressive symptoms: a randomized controlled trial.

Depressive symptoms are common in glioma patients, and can negatively affect health-related quality of life (HRQOL). We performed a nation-wide randomized controlled trial to evaluate the effects of an online guided self-help intervention for depressive symptoms in adult glioma patients. Glioma patients with depressive symptoms were randomized to a 5-week online course based on problem-solving therapy, or a waiting list control group. After having received the intervention, the glioma patient groups combined were compared with patients with cancer outside the central nervous system (non-CNS cancer controls), who also received the intervention. Sample size calculations yielded 63 participants to be recruited per arm. The primary outcome [depressive symptoms (CES-D)] and secondary outcomes [fatigue (Checklist Individual Strength (CIS)) and HRQOL (Short Form-36)], were assessed online at baseline, post-intervention, and 3 and 12 months follow-up. In total, 89 glioma patients (intervention N = 45; waiting list N = 44) and 26 non-CNS cancer controls were included, of whom 35 and 54% completed the intervention, respectively. Recruitment could not be extended beyond 3.5 years due to funding. On depression, no statistically significant differences between the groups were found. Fatigue decreased post-treatment in the glioma intervention group compared with the waiting list group (p = 0.054, d = 0.306). At 12 months, the physical component summary (HRQOL) remained stable in glioma patients, while scores improved in non-CNS cancer controls (p = 0.035, d = 0.883). In this underpowered study, no evidence for the effectiveness of online guided self-help for depression or HRQOL in glioma patients was found, but it may improve fatigue. Trial registration Netherlands Trial Register NTR3223.

Family caregivers' level of mastery predicts survival of patients with glioblastoma: A preliminary report.

BACKGROUND: Glioblastoma multiforme (GBM) is associated with a poor prognosis, and patients rely heavily on family caregivers for physical and emotional support. The capability and mental health of family caregivers may influence their ability to provide care and affect patient outcomes. The objective of the current study was to investigate whether caregivers' anxiety, depressive symptoms, burden, and mastery influenced survival in a sample of patients newly diagnosed with GBM. METHODS: Baseline data from caregiver-patient dyads participating in a longitudinal study funded by the National Institutes of Health were used. Cox regression analyses were performed to determine whether caregiver anxiety (Profile of Mood States-Anxiety), depressive symptoms (Center for Epidemiologic Studies-Depression Scale), burden (Caregiver Reaction Assessment), and feelings of mastery (Mastery Scale) predicted the survival time of patients with GBM after controlling for known covariates (patient age, Karnofsky performance status, type of surgery, and postsurgical treatment). RESULTS: A total of 88 caregiver-patient dyads were included. The median overall survival for the sample was 14.5 months (range, 0-88 months). After controlling for covariates, caregiver mastery was found to be predictive of patient survival. With each unit increase in mastery, there was a 16.1% risk reduction in patient death (95% confidence interval, 0.771-0.913; P<.001). CONCLUSIONS: To the authors' knowledge, the results of the current study are among the first to explore the impact of family caregiving on the outcomes of patients with GBM. If these results are supported in other studies, providing neuro-oncology caregivers with more structured support and guidance in clinical practice has the potential to improve caregivers' feelings of mastery, thereby influencing patients' well-being for the better. Cancer 2017;123:832-40. © 2016 American Cancer Society.

Neuro-oncology family caregivers' view on keeping track of care issues using eHealth systems: it's a question of time.

Primary brain tumors (PBTs) are rare but have a great impact on both patient and family caregiver wellbeing. Supporting caregivers can help them to continue their caregiving activities to maintain the patients' best possible level of quality of life. Efforts to improve PBT caregiver wellbeing should take into account country- or culture-specific differences in care issues and supportive care needs to serve larger caregiver groups. We aimed to explore PBT caregivers' satisfaction with the current supportive care provision, as well as their thoughts on monitoring their care issues with both paper-based and digital instruments. Twelve PBT caregivers were interviewed in the United States. The semi-structured interviews were transcribed verbatim and analyzed by two coders independently. Data were combined with those collected in the Netherlands, following similar methodology (N = 15). We found that PBT caregivers utilize both formal and informal support services, but that those who experience more care issues would prefer more support, particularly in the early disease phase. Keeping track of care issues was thought to provide more insight into unmet needs and help them find professional help, but it requires investment of time and takes discipline. Caregivers preferred a brief and easy-to-use 'blended care' instrument that combines digital monitoring with personal feedback. The present study shows that the preferences of family caregivers in neuro-oncology toward keeping track of care issues are likely not heavily influenced by country- or culture-specific differences. The development of any instrument thus has the potential to benefit a large group of family caregivers.