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Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.

ABSTRACT: BACKGROUND:Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring the feasibility of the intervention by patients, professionals and caregivers and on assessing its preliminary efficacy. METHODS/DESIGN:This is a mixed-methods phase 2 trial. The Specialist Palliative Care Team (SPCT) will follow each patient on a monthly basis in the outpatient clinic or will provide consultations during any hospital admission. SPCT and haematologists will discuss active patient issues to assure a team approach to the patient's care. This quantitative study is a monocentric parallel-group superiority trial with balanced randomisation comparing the experimental PCI plus haematological standard care versus haematological standard care alone. The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24?weeks after randomisation. The qualitative study follows the methodological indications of concurrent nested design and was aimed at exploring the acceptability of the PCI from the point of view of patients, caregivers and physicians. DISCUSSION:In this trial, we will test the feasibility of an integrated palliative care approach starting when the haematologist decides to propose the last active treatment to the patient, according to his/her clinical judgement. We decided to test this criterion because it is able to intercept a wide range of patients'needs. The feasibility of this approach requires that we enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24?weeks. The trial will include integrated qualitative data analysis; to give essential information on feasibility and acceptability. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03743480 (November 16, 2018).

SUBMITTER: Tanzi S

PROVIDER: S-EPMC7178743 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.

Tanzi Silvia S Luminari Stefano S Cavuto Silvio S Turola Elena E Ghirotto Luca L Costantini Massimo M

BMC palliative care 20200422 1

<h4>Background</h4>Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring t ...[more]

PMID: 32321483

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Project description:BackgroundIntensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial is to assess the feasibility of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically possible versus standard care in the intensive care unit. The feasibility study is intended to inform a subsequent randomised clinical trial that will investigate benefits and harms of the intervention.MethodsThis randomised clinical feasibility trial with a follow-up period of 1 year will use blinded outcome assessors for the Coma Recovery Scale-Revised. A maximum of 60 patients admitted to the neurointensive care unit at Rigshospitalet, Denmark, with traumatic brain injury (age of at least 18 years), a low level of consciousness, and stable intracranial pressure will be included in the trial. Patients will be randomly assigned to experimental intervention versus standard care (1:1) stratified according to their Glasgow Coma Score. The intervention group will receive daily mobilisation in a tilt table with an integrated stepping device (ERIGO®). Feasibility is declared if more than 60% (the lower 95% confidence interval of the proportion) of eligible patients are included in the trial and more than 52% (the lower 95% confidence interval of the proportion) of patients in the intervention group receive more than 60% of the planned interventions. Safety is assessed by the occurrence of adverse events and adverse reactions. Exploratory clinical outcomes consist of cerebral haemodynamics (blood flow velocity and pressure autoregulation) and baroreceptor sensitivity in the early phase as well as functional outcomes (Coma Recovery Scale-Revised, Early Functional Ability scale, and Functional Independence Measure).DiscussionOur findings will inform a future, larger-scale randomised clinical trial on early mobilisation using a tilt table early after severe traumatic brain injury.Trial registrationClinicalTrials.gov identifier: NCT02924649 . Registered on 3 October 2016.

Project description:Palliative care patients are a particularly vulnerable population and one of the critical phases in patients' trajectories is discharge from specialized in-patient palliative care into outpatient care, where availability of a palliative care infrastructure is highly variable. A relevant number of potentially avoidable readmissions and emergency visits of palliative patients is observed due to rapid exacerbation of symptoms indicating the need for a closer patient monitoring. In the last years, different mHealth technology applications have been evaluated in many different patient groups.The aim of our study is to test feasibility of a remote physical and social tracking system in palliative care patients.A feasibility study with explorative, descriptive study design, comprised of 3 work packages. From the wards of the Clinic of Radiation-Oncology at the University Hospital Zurich, including the specialized palliative care ward, 30 patients will be recruited and will receive a mobile phone and a tracking bracelet before discharge. The aim of work package A is to evaluate if severely ill patients accept to be equipped with a tracking bracelet and a mobile phone (by semiquantitative questionnaires and guideline interviews). Work package B evaluates the technical feasibility and quality of the acquired electronic health data. Work package C will demonstrate whether physical activity parameters, such as step count, sleep duration, social activity patterns like making calls, and vital signs (eg, heart rate) do correlate with subjective health data and can serve as indicator to early detect and predict changes in patients' health status. Activity parameters will be extracted from the mobile phone's and wristband's sensor data using signal processing methods. Subjective health data is captured via electronic version of visual analog scale and Distress Thermometer as well as the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire C30 in paper version.Enrollment began in February 2017. First study results will be reported in the middle of 2018.Our project will deliver relevant data on patients' acceptance of activity and social tracking and test the correlation between subjective symptom assessment and objective activity in the vulnerable population of palliative care patients. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on symptom control and quality of life.

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Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.

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Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.

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