Preliminary results of a randomized controlled trial of early integration of specialist palliative care within a tertiary cancer center in the Czech Republic.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 113-113
Author(s):  
Ondrej Slama ◽  
Lukas Pochop ◽  
Lucie Svetlakova ◽  
Ondrej Bilek ◽  
Jiri Sedo ◽  
...  

113 Background: Clinical trials in the U.S. and Canada have shown the benefit for patients and the health care system of early integration of palliative care into oncological practice. Nevertheless the practical realisation and the timing of this integration may be controversial. The optimal model of specialist palliative care (SPC) involvement may depend on the quality of standard cancer care in the given country. Methods: We present preliminary results of a randomised controlled trial of early integration of SPC conducted in the largest tertiary cancer center in Czech Republic. The trial compares standard oncology care with integrated SPC to standard oncology care alone in patients with advanced solid tumors treated with palliative antineoplastic therapy. The design of the study is inspired by the study of early PC for patients with advanced NSCLC byTemel et al. (2010). The SPC intervention consists of consultations with palliative care team every 6 weeks. Outcomes assessed at baseline and at 3 and 6 months after enrollment are quality of life (EORTC-QoL-Q30), anxiety and depression (HADS) and structure and cost of end of life care. Results: 100 patients have been randomisd between September 2015 and January 2017 (integrated PC 51 pts, conotrole 49pts). There were differences at 3 and 6 months in QoL (66% vs. 55%, p > 0,05; 63% vs. 49% p > 0,05), prevalence of anxiety (37% vs. 43%, p > 0,05; 32% vs. 54%, p > 0,05) and depression (19% vs. 29% p = 0,02; 20% vs. 27% p > 0,05) in intergated and control arm respectively. The mean time from the last chemotherapy to death was 66 days vs.52 days (p = 0,04) and the enrollment rate to hospice programme was 63% vs. 43% (p = 0,02) at the end of life in favour of integrated palliative care. Conclusions: There seem to be a trend for better results in patient reported outcomes and reasonable resource utilisation in favour of integrated care model in the context of advanced cancer care in Czech Republic. But differences between study arms did not reach statistical significance in patient reported outcomes, probably due to small number of patients. We hope to enrol enough patients within next 6 months to overcome this limitation.

2021 ◽  
Vol 162 (44) ◽  
pp. 1769-1775
Author(s):  
Orsolya Horváth ◽  
Enikő Földesi ◽  
Katalin Hegedűs

Összefoglaló. A palliatív ellátások korai bevonása az onkológiai betegek ellátásába előnnyel jár mind a beteg életminősége, mind a kezelés színvonala, mind a költséghatékonyság szempontjából. Szükség van egy olyan modellre, mely alapján a megfelelő időben, a megfelelő beteg a megfelelő minőségű palliatív ellátásban részesül. Ebben a közleményben a palliatív ellátás korai integrációjának előnyei, szintjei és a speciális palliatív ellátás fogalmának ismertetése után a leginkább elterjedt beutalási modellek előnyeit és hátrányait mutatjuk be a nemzetközi szakirodalom alapján. A speciális palliatív ellátást igénylő betegek kiszűrésére szolgáló, prognózisalapú modellek hátránya, hogy nincs elég kapacitás az ilyen módon beutalt nagyszámú beteg ellátására, ezért széles körben nem terjedtek el. A tüneteken alapuló modellek sokszor bonyolultak és a mindennapi klinikai gyakorlatban nem használatosak. Az új kutatások alapján egyszerű, gyakorlatias kérdéssorokat alkalmaznak, melyekkel könnyen kiemelhetők, akik profitálnak a speciális palliatív intervencióból. Ezek közül a Yale egyetemi és a PALLIA -10 modellt ismertetjük részletesen. Amennyiben az aktív onkológiai ellátást végzők a megfelelő palliatív beutalási kritériumokat ismerik és alkalmazzák, a betegek időben jutnak a megfelelő komplex kezeléshez anélkül, hogy a palliatív ellátórendszer túlterhelődne. Orv Hetil. 2021; 162(44): 1769–1775. Summary. Early integration of palliative care into the trajectory of cancer care brings advantages into the patients’ quality of life, the level of care and cost-efficiency, too. On the basis of a predefined model, the right patient may receive the right level of palliative care at the right time. Having defined the advantages, the levels of early integration of palliative care and the concept of special palliative care, we also aim to describe the advantages and disadvantages of the most common referral models on the basis of international literature in this article. The drawback of prognosis-based models to identify patients needing special palliative care is the lack of capacity to provide care for the large number of patients so recognised; therefore they have not become widespread. Needs-based models tend to be complicated and thus rarely applied in everyday clinical practice. On the basis of new researches, simple, pragmatic questionnaires are utilised through which the patients who could benefit from special palliative care interventions are easy to identify. Here we give a detailed report of the Yale University and PALLIA-10 models. On condition that appropriate palliative referral criteria are known and applied by active oncology care providers, patients may receive adequate complex care without the palliative care system being overloaded. Orv Hetil. 2021; 162(44): 1769–1775.


Author(s):  
David Hui

This chapter discusses the Zimmermann trial, a large partially blinded, cluster randomized controlled trial of routine oncology care with or without early routine referral to palliative care. This landmark study found that early palliative care involvement was associated with improved quality of life, symptom burden and satisfaction among patients with advanced cancer. This chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case to illustrate some key points around palliative care referral.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vivienne Kahlmann ◽  
◽  
Montse Janssen Bonás ◽  
Catharina C. Moor ◽  
Coline H. M. van Moorsel ◽  
...  

Abstract Background Treatment of pulmonary sarcoidosis is recommended in case of significant symptoms, impaired or deteriorating lung function. Evidence-based treatment recommendations are limited and largely based on expert opinion. Prednisone is currently the first-choice therapy and leads to short-term improvement of lung function. Unfortunately, prednisone often has side-effects and may be associated with impaired quality of life. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. Objective The primary objective of this trial is to investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis compared with prednisone. The primary endpoint of this study will be the change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks. Secondary objectives are to gain more insights in response to therapy in individual patients by home spirometry and patient-reported outcomes. Blood biomarkers will be examined to find predictors of response to therapy, disease progression and chronicity, and to improve our understanding of the underlying disease mechanism. Methods/design In this prospective, randomized, non-blinded, multi-center, non-inferiority trial, we plan to randomize 138 treatment-naïve patients with pulmonary sarcoidosis who are about to start treatment. Patients will be randomized in a 1:1 ratio to receive either prednisone or methotrexate in a predefined schedule for 24 weeks, after which they will be followed up in regular care for up to 2 years. Regular hospital visits will include pulmonary function assessment, completion of patient-reported outcomes, and blood withdrawal. Additionally, patients will be asked to perform weekly home spirometry, and record symptoms and side-effects via a home monitoring application for 24 weeks. Discussion This study will be the first randomized controlled trial comparing first-line treatment of prednisone and methotrexate and provide valuable data on efficacy, safety, quality of life and biomarkers. If this study confirms the hypothesis that methotrexate is as effective as prednisone as first-line treatment for sarcoidosis but with fewer side-effects, this will lead to improvement in care and initiate a change in practice. Furthermore, insights into the immunological mechanisms underlying sarcoidosis pathology might reveal new therapeutic targets. Trial registration The study was registered on the 19th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; ID NCT04314193.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6537-6537
Author(s):  
Brooke Worster ◽  
Valerie P Csik ◽  
Jared Minetola ◽  
Gregory D. Garber ◽  
Alison Petok ◽  
...  

6537 Background: Evidence suggests that cancer patients who receive palliative care early in their disease have improved quality of life, decreased emergency department (ED) visits, and less aggressive end-of-life care. In 2017, the Sidney Kimmel Cancer Center at Jefferson established the Neu Center for Supportive Medicine and Cancer Survivorship (NCSMCS) as a model for integrated care in the outpatient setting for all cancer patients. A multidisciplinary team consisting of palliative care physicians, social work, psychology, and navigation conducts biopsychosocial screening and initiates a personalized care plan for each patient to clarify treatment goals and offer assistance. Objectives: To use biopsychosocial screening at specified time points to identify needs and evaluate the impact of supportive care as part of standardized oncology care regardless of stage. Methods: This assessment utilized Oncology Care Model (OCM) data for Jefferson Medicare patients between 7/1/16 to 7/31/18. Incidence of ED admits ED/Observation and admissions were evaluated as well as ICU utilization and advanced care planning. Poisson regression was used to generate incidence rate ratios (IRR) and 95% confidence intervals (CI) to facilitate the comparison of post- vs. pre- incidence rates of hospitalization. Results: The post-intervention hospital admissions decreased by 31% in NCSMCS (IRR 0.69; 95% CI 0.48-0.98) and by 10% in Non-NCSMCS (IRR 0.90; 0.84-0.96) and advanced care plans were more likely to be on file for NCSMCS (9.0% vs. 4.9%). The intensive care unit (ICU) admissions were decreased by 17% among Non-NCSMCS (IRR 0.83; 95% CI 0.74-0.93). The utilization rates for ED admissions were not statistically different among both the groups. Conclusions: The preliminary data is promising and impact will be monitored as the intervention is expanded. Reducing admissions has benefits from both a cost savings as well as quality of life perspective. Future analyses will consider the impact of the intervention on a patient’s quality of life.


2016 ◽  
Vol 34 (6) ◽  
pp. 557-565 ◽  
Author(s):  
Ethan Basch ◽  
Allison M. Deal ◽  
Mark G. Kris ◽  
Howard I. Scher ◽  
Clifford A. Hudis ◽  
...  

Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited. Methods We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival. Results Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts. Conclusion Clinical benefits were associated with symptom self-reporting during cancer care.


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