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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.

ABSTRACT: ?INTRODUCTION: Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group. ?METHODS AND ANALYSIS: The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL ('optimised' standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients' palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival. ?ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences. TRIAL REGISTRATION NUMBER: German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.

SUBMITTER: Golla H

PROVIDER: S-EPMC6955518 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.

Golla Heidrun H Nettekoven Charlotte C Bausewein Claudia C Tonn Jörg-Christian JC Thon Niklas N Feddersen Berend B Schnell Oliver O Böhlke Christopher C Becker Gerhild G Rolke Roman R Clusmann Hans H Herrlinger Ulrich U Radbruch Lukas L Vatter Hartmut H Güresir Erdem E Stock Stephanie S Müller Dirk D Civello Daniele D Papachristou Irini I Hellmich Martin M Hamacher Stefanie S Voltz Raymond R Goldbrunner Roland R

BMJ open 20200107 1

INTRODUCTION: Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients ...[more]

PMID: 31915175

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Project description:IntroductionIntegrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs.Methods and analysisWe are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients.Ethics and disseminationThe study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations.Trial registration numberNCT03337399.

Project description:IntroductionThe systematic collection of electronic patient-reported outcome (ePRO) in the routine care of patients with chronic haematological malignancies such as chronic lymphocytic leukaemia (CLL) and myelodysplasia syndromes (MDS) can constitute a very ambitious but worthwhile challenge. MyPal is a Horizon 2020 Research & Innovation Action aiming to meet this challenge and foster palliative care for patients with CLL or MDS by leveraging ePRO systems to adapt to the personal needs of patients and caregiver(s).Methods and analysisIn this interventional randomised trial, 300 patients with CLL or MDS will be recruited across Europe. Patients will be randomly allocated to early palliative care using the MyPal system (n=150) versus standard care including general palliative care if needed (n=150). Patients in the experimental arm will be given access to the MyPal digital health platform which consists of purposely designed software available on smartphones and/or tablets. The platform entails different functionalities including physical and psychoemotional symptom reporting via regular questionnaire completion, spontaneous self-reporting, motivational messages, medication management and a personalised search engine for health information. Data on patients' activity (daily steps and sleep quality) will be automatically collected via wearable devices.Ethics and disseminationThe integration of ePROs via mobile applications has raised ethical concerns regarding inclusion criteria, information provided to participants, free and voluntary consent, and respect for their autonomy. These have been carefully addressed by a multidisciplinary team. Data processing, dissemination and exploitation of the study findings will take place in full compliance with European Union data protection law. A participatory design was adopted in the development of the digital platform involving focus groups and discussions with patients to identify needs and preferences. The protocol was approved by the ethics committees of San Raffaele (8/2020), Thessaloniki 'George Papanikolaou' Hospital (849), Karolinska Institutet (20.10.2020), University General Hospital of Heraklion (07/15.4.2020) and University of Brno (01-120220/EK).Trial registration numberNCT04370457.

Project description:BackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?MethodsThe Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n?=?940) are pregnant smokers (age?>?16 years, <?24?weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6?months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6?months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK?DiscussionThis phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women.Trial registrationCurrent Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Project description:BackgroundPrevious studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as 'a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment.Methods/designThe primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization.DiscussionDespite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced cancer may benefit from a psychosocial and educational strategy that adequately prepares them for initial PC appointments after an early referral to PC. We anticipate that benefits of psychological intervention shall be synergistic to secondary emotional benefits from the early integration of PC.Trial registrationThis trial was registered on 6 May 2014 with ClinicalTrials.gov (identifier: NCT02133274).

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Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.

Publications

Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.

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