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The palliative care field is experiencing substantive growth in clinical trial-based research. Randomized controlled trials provide the necessary rigor and conditions for assessing a treatment's efficacy in a controlled population. It is therefore important that a trial is meticulously designed from the outset to ensure the integrity of the ultimate results. In this article, our team discusses ten tips on clinical trial design drawn from collective experiences in the field. These ten tips cover a range of topics that can prove challenging in trial design, from developing initial methodologies to planning sample size and powering the trial, as well as collaboratively navigating the ethical issues of trial initiation and implementation as a cohesive team. We aim to help new researchers design sound trials and continue to grow the evidence base for our specialty. The guidance provided here can be used independently or in addition to the ten tips provided by this team in a separate article focused on what palliative care clinicians should know about interpreting a clinical trial.
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Evidence-based practice is foundational to high-quality palliative care delivery. However, the clinical trials that compose the evidence base are often methodologically imperfect. Applying their conclusions without critical application to the clinical practice context can harm patients. The tips provided can help clinicians infer judiciously from clinical trial results and avoid credulously accepting findings without critique. We suggest that statistical and mathematical expertise is unnecessary, but rather a keen curiosity about investigators' rationale for certain design choices and how these choices can affect results is key. For a more comprehensive understanding of clinical trials, this article can be used with the authors' corresponding ten tips article that focuses on designing a clinical trial.
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PURPOSE: This study investigated pancreatic enzyme replacement therapy (PERT) use in people diagnosed with pancreatic cancer in New Zealand (NZ) and Australia (AU). METHODS: A cross-sectional survey study was conducted using a mixed-media campaign to recruit people with pancreatic cancer and collect information about current PERT use. The questionnaire gathered data on participant demographics, awareness of PERT, prescribing practices and efficacy of enzyme replacement. RESULTS: Over 300 people with pancreatic cancer were recruited, 135 from New Zealand and 199 from Australia. Every region, state and territory was represented except for the West Coast (NZ) and the Northern Territory (AU), the lowest populated areas in both countries. In New Zealand, 60% of participants had heard about PERT, compared to 69.3% in Australia. Dosing regimens were inconsistent in both countries, with 18% and 27% of participants being prescribed PERT considered best practice in New Zealand and Australia, respectively. Before PERT commencement, 70% of participants experienced symptoms of malabsorption, with all symptoms improving after therapy was established. The majority of participants were compliant with their medication. CONCLUSION: PERT use in pancreatic cancer in New Zealand and Australia was highly variable and not compliant with international guidelines in which PERT is recommended as standard therapy. Enzyme replacement is effective for improving the symptoms of malabsorption in patients with pancreatic cancer. Clinician education may be needed to help improve the use of PERT in people with pancreatic cancer.
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Terapia de Reposição de Enzimas , Neoplasias Pancreáticas , Humanos , Estudos Transversais , Neoplasias Pancreáticas/tratamento farmacológico , Nova Zelândia , Feminino , Masculino , Terapia de Reposição de Enzimas/métodos , Pessoa de Meia-Idade , Austrália , Idoso , Inquéritos e Questionários , Adulto , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: We aimed to define levels of unmet supportive care needs in people with primary brain tumor and to reach expert consensus on feasibility of addressing patients' needs in clinical practice. METHODS: We conducted secondary analysis of a prospective cohort study of people diagnosed with high-grade glioma (n = 116) who completed the Supportive Care Needs Survey-Short Form during adjuvant chemoradiation therapy. Participants were allocated to 1 of 3 categories: no need ("no need" for help on all items), low need ("low need" for help on at least 1 item, but no "moderate" or "high" need), or moderate/high need (at least 1 "moderate" or "high" need indicated). Clinical capacity to respond to the proportion of patients needing to be prioritized was assessed. RESULTS: Overall, 13% (n = 5) were categorized as no need, 23% (n = 27) low need, and 64% (n = 74) moderate/high need. At least 1 moderate/high need was reported in the physical and daily living domain (42%) and the psychological (34%) domain. In recognition of health system capacity, the moderate/high need category was modified to distinguish between moderate need ("moderate" need indicated for at least 1 item but "high" need was not selected for any item) and high need (at least 1 "high" need indicated). Results revealed 24% (n = 28) moderate need and 40% (n = 46) high need. Those categorized as high need indicated needing assistance navigating the health system and information. CONCLUSIONS: Using four step allocations resulted in 40% of patients indicating high need. Categories may facilitate appropriate triaging and guide stepped models of healthcare delivery.
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Neoplasias Encefálicas , Glioma , Necessidades e Demandas de Serviços de Saúde , Avaliação das Necessidades , Humanos , Glioma/terapia , Neoplasias Encefálicas/terapia , Neoplasias Encefálicas/psicologia , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Idoso , Adulto , Quimiorradioterapia Adjuvante , Atividades Cotidianas , Estudos de Viabilidade , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: Family involvement in the lives of people who have dementia and live in long-term care is important, but family members may face challenges communicating and connecting with their loved one as dementia progresses. A type of therapeutic humor (Laughter Care) delivered by trained specialists aims to engage people with dementia who reside in long-term care through creative play and laughter. This study aimed to explore the perceptions of Laughter Care Specialists (LCSs) regarding families' engagement with the program. METHODS: Semi-structured interviews were conducted with LCSs (n = 8) and analyzed inductively using thematic analysis. RESULTS: Family members were reported to initially have varied degrees of openness toward Laughter Care, but often become more accepting after observing positive engagement with the person with dementia. Family members were perceived to benefit from the program through witnessing the person with dementia enjoy joyous and light interactions, learn new ways of communicating and connecting with the person with dementia, and engage in positive interactions at end of life. SIGNIFICANCE OF RESULTS: Laughter Care may provide family members with novel ways of communicating and connecting with people who have dementia at end of life as well as comfort into bereavement.
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PURPOSE: People with advanced or metastatic cancer and their caregivers may have different care goals and face unique challenges compared with those with early-stage disease or those nearing the end of life. These Multinational Association for Supportive Care in Cancer (MASCC)-ASCO standards and practice recommendations seek to establish consistent provision of quality survivorship care for people affected by advanced or metastatic cancer. METHODS: A MASCC-ASCO expert panel was formed. Standards and recommendations relevant to the provision of quality survivorship care for people affected by advanced or metastatic cancer were developed through conducting (1) a systematic review of unmet supportive care needs; (2) a scoping review of cancer survivorship, supportive care, and palliative care frameworks and guidelines; and (3) an international modified Delphi consensus process. RESULTS: A systematic review involving 81 studies and a scoping review of 17 guidelines and frameworks informed the initial standards and recommendations. Subsequently, 77 experts (including eight people with lived experience) across 33 countries (33% were low- to middle-resource countries) participated in the Delphi study and achieved ≥94.8% agreement for seven standards, (1) Person-Centered Care; (2) Coordinated and Integrated Care; (3) Evidence-Based and Comprehensive Care; (4) Evaluated and Communicated Care; (5) Accessible and Equitable Care; (6) Sustainable and Resourced Care; and (7) Research and Data-Driven Care, and ≥84.2% agreement across 45 practice recommendations. CONCLUSION: Standards of survivorship care for people affected by advanced or metastatic cancer are provided. These MASCC-ASCO standards support optimization of health outcomes and care experiences by providing guidance to stakeholders (health care professionals, leaders, and administrators; governments and health ministries; policymakers; advocacy agencies; cancer survivors and caregivers). Practice recommendations may be used to facilitate future research, practice, policy, and advocacy efforts.Additional information is available at www.mascc.org, www.asco.org/standards and www.asco.org/survivorship-guidelines.
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PURPOSE: People with advanced or metastatic cancer and their caregivers may have different care goals and face unique challenges compared to those with early-stage disease or those nearing the end-of-life. These MASCC-ASCO standards and practice recommendations seek to establish consistent provision of quality survivorship care for people affected by advanced or metastatic cancer. METHODS: An expert panel comprising MASCC and ASCO members was formed. Standards and recommendations relevant to the provision of quality survivorship care for people affected by advanced or metastatic cancer were developed through conducting: (1) a systematic review of unmet supportive care needs; (2) a scoping review of cancer survivorship, supportive care, and palliative care frameworks and guidelines; and (3) an international modified Delphi consensus process. RESULTS: A systematic review involving 81 studies and a scoping review of 17 guidelines and frameworks informed the initial standards and recommendations. Subsequently, 77 experts (including 8 people with lived experience) across 33 countries (33% were low-to-middle resource countries) participated in the Delphi study and achieved ≥ 94.8% agreement for seven standards (1. Person-Centred Care; 2. Coordinated and Integrated Care; 3. Evidence-Based and Comprehensive Care; 4. Evaluated and Communicated Care; 5. Accessible and Equitable Care; 6. Sustainable and Resourced Care; 7. Research and Data-Driven Care) and ≥ 84.2% agreement across 45 practice recommendations. CONCLUSION: Standards of survivorship care for people affected by advanced or metastatic cancer are provided. These MASCC-ASCO standards will support optimization of health outcomes and care experiences by providing guidance to stakeholders in cancer care (healthcare professionals, leaders, and administrators; governments and health ministries; policymakers; advocacy agencies; cancer survivors and caregivers. Practice recommendations may be used to facilitate future research, practice, policy, and advocacy efforts.
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Sobreviventes de Câncer , Neoplasias , Cuidados Paliativos , Sobrevivência , Humanos , Técnica Delphi , Metástase Neoplásica , Neoplasias/terapia , Cuidados Paliativos/normas , Cuidados Paliativos/métodos , Assistência Centrada no Paciente/normas , Assistência Centrada no Paciente/organização & administração , Guias de Prática Clínica como Assunto , Qualidade da Assistência à Saúde/normasRESUMO
BACKGROUND: Population preferences for care at the end of life can inform palliative care policy and direction. Research investigating preferences for care at the end of life has focused predominantly on the context of advanced cancer, with relatively little attention to other life-limiting illnesses that are common causes of death. OBJECTIVES: We aimed to investigate preferences for the care of older people at the end of life in three different disease contexts. The purpose was to understand if population preferences for care in the last 3 weeks of life would differ for patients dying from cancer, heart failure or dementia. METHODS: Three discrete choice experiments were conducted in Australia with a general population sample using similar methods but different end-of-life disease contexts. Some attributes were common across the three experiments and others differed to accommodate the specific disease context. Each survey was completed by a different panel sample aged ≥45 years (cancer, n = 1548; dementia, n = 1549; heart failure, n = 1003). Analysis was by separate mixed logit models. RESULTS: The most important attributes across all three surveys were costs to the patient and family, patient symptoms and informal carer stress. The probability of choosing an alternative was lowest (0.18-0.29) when any one of these attributes was at the least favourable level, holding other attributes constant across alternatives. The cancer survey explored symptoms more specifically and found patient anxiety with a higher relative importance score than the symptom attribute of pain. Dementia was the only context where most respondents preferred to not have a medical intervention to prolong life; the probability of choosing an alternative with a feeding tube was 0.40 (95% confidence interval 0.36-0.43). CONCLUSIONS: This study suggests a need for affordable services that focus on improving patient and carer well-being irrespective of the location of care, and this message is consistent across different disease contexts, including cancer, heart failure and dementia. It also suggests some different considerations in the context of people dying from dementia where medical intervention to prolong life was less desirable.
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Demência , Insuficiência Cardíaca , Neoplasias , Preferência do Paciente , Assistência Terminal , Humanos , Masculino , Feminino , Idoso , Assistência Terminal/organização & administração , Pessoa de Meia-Idade , Austrália , Idoso de 80 Anos ou mais , Neoplasias/terapia , Neoplasias/psicologia , Insuficiência Cardíaca/terapia , Cuidadores/psicologia , Cuidados Paliativos/organização & administração , Comportamento de Escolha , Inquéritos e QuestionáriosRESUMO
Objective: To describe the harms in all arms of six consecutive multi-site, double-blind, placebo-controlled randomised clinical trials. Background: Controversies surround conduct of phase III clinical trials in palliative care. Concerns include risks to participants' safety, use of placebo arms, participants' burden, and justification when therapies are already widely used. Methods: This study collates safety data of the first six studies of the Australian national Palliative Care Clinical Studies Collaborative. On an intention-to-treat basis, all harms are described using standard international definitions, their severity, outcomes, and level of attribution. Results: Studies recruited 1,232 participants: 65/1,232 (5.3%) participants had serious adverse events of which none had a definite (blinded) attribution, all of which settled with ceasing the intervention; 49/1,232 (4.0%) participants had adverse events. No participants on placebo arms had adverse or serious adverse events with definite (blinded) attribution. Discussion: These studies are safe for participants and generate knowledge to support informed patient decision making.
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Hospitais para Doentes Terminais , Cuidados Paliativos , Humanos , Austrália , Método Duplo-CegoRESUMO
Objective: To identify and appraise mobile-based application (mAPP) interventions that have been used to support cancer control and care in low- and middle-income countries (LMICs). Methods: Four electronic databases were systematically searched for studies that reported primary research findings related to mAPP interventions applied in oncology settings in LMICs. A narrative synthesis was performed using the Mhealth Index and Navigation Database as an analytical framework. Results: Twenty studies reporting 18 cancer control and care mAPPs were included in this review. Among these mAPPs, ten focused on prevention, screening and early detection of cancer, five provided information to optimise supportive and palliative care, two provided support to assist treatment-shared decision-making and one covered information for follow-up and survivorship care. Conclusion: Cancer mAPP interventions are gradually gaining attention in LMICs as they provide unique resources for empowering and strengthening the role of people with cancer in their own care. To enhance cancer control, a focus on prevention and early detection is important; however, more mAPP interventions related to cancer treatment, follow-up and survivorship are also needed to enable more cost-effective cancer care.
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Aplicativos Móveis , Neoplasias , Telemedicina , Humanos , Países em Desenvolvimento , Atenção à Saúde , Neoplasias/prevenção & controleRESUMO
BACKGROUND: Ketamine at subanaesthetic dosages (≤0.5mg/kg) exhibits rapid onset (over hours to days) antidepressant effects against major depressive disorder in people who are otherwise well. However, its safety, tolerability and efficacy are not known for major depressive disorder in people with advanced life-limiting illnesses. OBJECTIVE: To determine the feasibility, safety, tolerability, acceptability and any antidepressant signal/activity to justify and inform a fully powered study of subcutaneous ketamine infusions for major depressive disorder in the palliative setting. METHODS: This was a single arm, open-label, phase II feasibility study (Australian New Zealand Clinical Trial Registry Number-ACTRN12618001586202). We recruited adults (≥ 18-years-old) with advanced life-limiting illnesses referred to four palliative care services in Sydney, Australia, diagnosed with major depressive disorder from any care setting. Participants received weekly subcutaneous ketamine infusion (0.1-0.4mg/kg) over two hours using individual dose-titration design. Outcomes assessed were feasibility, safety, tolerability and antidepressant activity. RESULTS: Out of ninety-nine referrals, ten participants received ketamine and were analysed for responses. Accrual rate was 0.54 participants/month across sites with 50% of treated participants achieving ≥ 50% reduction in baseline Montgomery-Åsberg Depression Rating Scale, meeting feasibility criteria set a priori. There were no clinically relevant harms encountered. CONCLUSIONS: A future definitive trial exploring the effectiveness of subcutaneous infusion of ketamine for major depressive disorder in the palliative care setting may be feasible by addressing identified study barriers. Individual dose-titration of subcutaneous ketamine infusions over two hours from 0.1mg/kg can be well-tolerated and appears to produce transient antidepressant signals over hours to days.
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Transtorno Depressivo Maior , Transtorno Depressivo Resistente a Tratamento , Ketamina , Adulto , Humanos , Adolescente , Ketamina/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Estudos de Viabilidade , Infusões Intravenosas , Austrália , Antidepressivos/uso terapêutico , Infusões Subcutâneas , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Resultado do TratamentoRESUMO
Background: People living with high-grade glioma (HGG) have diverse and complex needs. Screening aims to detect patients with some level of unmet need requiring triaging and further assessment. However, most existing measures of unmet need are not suitable for screening in this population due to their length. We aimed to explore the clinical utility of a brief screening tool (SCNS-ST9) in people with HGG in detecting unmet needs. Methods: Secondary analysis of data collected in a prospective cohort study of 116 people with HGG who completed the Supportive Care Needs Survey (SCNS-SF34) and a brain cancer-specific needs survey (BrTSCNS) during chemoradiation (T1) and 6 months later (T2). The SCNS-ST9 contains a subset of 9 items from the SCNS-SF34. Data analysis determined the number of individuals with unmet needs on the SCNS-SF34 and the BrTSCNS, not identified as having some level of need by the SCNS-ST9. Results: Overall, 3 individuals (T1: 2.6% [3/116]; T2: 4.8% [3/63]) at each time point reported other unmet needs on the SCNS-SF34 that were missed by the SCNS-ST9. Domain-specific screening items missed a higher proportion of individuals (3.2%-26%), particularly in the psychological and health systems domains. Only 1 individual with brain cancer-specific needs was missed by SCNS-ST9 overall. Conclusion: Findings demonstrate the sensitivity and clinical utility of a brief screening tool (SCNS-ST9) of unmet needs in people with HGG. Routine use of this screening tool, supported by clinical pathways, may improve access to support services, potentially reducing the burden of disease for these patients.
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BACKGROUND: The majority of cancer patients and cancer care clinicians-CCCs (e.g., oncologists) believe that exercise is an important adjunct therapy that should be embedded in standard practice. Yet, CCCs do not routinely discuss exercise with their patients, nor do they regularly refer them to exercise professionals (e.g., exercise physiologists-EPs). This study evaluated the feasibility and acceptability of an evidence-based approach to improving exercise communication between CCCs and their patients, including an exercise referral pathway. METHODS: Implementation and testing of the Exercise Communication and Referral Pathway (ECRP) occurred in Sydney, Australia. The ECRP included a brief oncology-initiated communication exchange with patients, CCC exercise referral to an EP, followed by EP-initiated telephone consultation with patients concerning tailored exercise advice. Participant perceptions concerning the feasibility and applicability of the ECPR were evaluated. Semi-structured interviews were conducted with CCCs (n = 3), cancer patients (n = 21), and an EP (n = 1). Inductive thematic analysis was undertaken. RESULTS: Analysis generated three themes: (1) Navigating the role of CCCs in the ECRP, suggesting that oncology-initiated communication is a cue to action, however there was a lack of role clarity regarding exercise referral; (2) Implementing Patient-Orientated Care within a Standardised Pathway, highlighting the need for tailored information and advice for patients that reflects individual disease, socio-cultural, and environmental factors, and; (3) Taking Steps Towards Action, revealing the need for structural (e.g., EP initiated contact with patients) and policy changes (i.e., changes to Medicare, direct oncologist referral) to engage patients and better integrate exercise as part of standard care. CONCLUSIONS: Findings provide important insights into improving oncology-patient exercise communication and developing an exercise referral pathway to increase engagement and patient reach. However, individual (e.g., experience, knowledge) and contextual factors (e.g., time, resources) need consideration when implementing an ECRP. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical (#ACTRN12620000358943) on March 13, 2020.
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Neoplasias , Encaminhamento e Consulta , Humanos , Idoso , Estudos de Viabilidade , Austrália , Telefone , Programas Nacionais de Saúde , Comunicação , Neoplasias/terapiaRESUMO
PURPOSE: This study asked consumers (patients, carers) and healthcare professionals (HCPs) to identify the most important symptoms for adults with cancer and potential treatment interventions. METHODS: A modified Delphi study was conducted involving two rounds of electronic surveys based on prevalent cancer symptoms identified from the literature. Round 1 gathered information on participant demographics, opinions and/or experience on cancer symptom frequency and impact, and suggestions for interventions and/or service delivery models for further research to improve management of cancer symptoms. In Round 2, respondents ranked the importance of the top ten interventions identified in Round 1. In Round 3, separate expert panels of consumers and healthcare professionals (HCPs) attempted to reach consensus on the symptoms and interventions previously identified. RESULTS: Consensus was reached for six symptoms across both groups: fatigue, constipation, diarrhoea, incontinence, and difficulty with urination. Notably, fatigue was the only symptom to reach consensus across both groups in Round 1. Similarly, consensus was reached for six interventions across both groups. These were the following: medicinal cannabis, physical activity, psychological therapies, non-opioid interventions for pain, opioids for breathlessness and cough, and other pharmacological interventions. CONCLUSIONS: Consumers and HCPs prioritise differently; however, the symptoms and interventions that reached consensus provide a basis for future research. Fatigue should be considered a high priority given its prevalence and its influence on other symptoms. The lack of consumer consensus indicates the uniqueness of their experience and the need for a patient-centred approach. Understanding individual consumer experience is important when planning research into better symptom management.
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Neoplasias , Humanos , Adulto , Técnica Delphi , Nova Zelândia , Austrália , Neoplasias/complicações , Neoplasias/terapia , Projetos de Pesquisa , Fadiga/etiologia , Fadiga/terapiaRESUMO
CONTEXT: Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat delirium in adults receiving palliative care report heterogeneous outcomes. OBJECTIVES: To undertake an international consensus process to develop a core outcome set for trials of interventions, designed to prevent and/or treat delirium, for adults receiving palliative care. METHODS: The core outcome set development process included a systematic review, qualitative interviews, modified Delphi method and virtual consensus meetings using nominal group technique (Registration http://www.comet-initiative.org/studies/details/796). Participants included family members, clinicians, and researchers with experience of delirium in palliative care. RESULTS: Forty outcomes were generated from the systematic review and interviews informing the Delphi Round one survey. The international Delphi panel comprised 92 participants including clinicians (n = 71, 77%), researchers (n = 13, 14%), and family members (n = 8, 9%). Delphi Round two was completed by 77 (84%) participants from Round one. Following the consensus meetings, four outcomes were selected for the core outcome set: 1) delirium occurrence (incidence and prevalence); 2) duration of delirium until resolution defined as either no further delirium in this episode of care or death; 3) overall delirium symptom profile (agitation, delusions or hallucinations, delirium symptoms and delirium severity); 4) distress due to delirium (person with delirium, and/or family and/or carers [including healthcare professionals]). CONCLUSION: Using a rigorous consensus process, we developed a core outcome set comprising four delirium-specific outcomes for inclusion in future trials of interventions to prevent and/or treat delirium in palliative care.
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Delírio , Projetos de Pesquisa , Adulto , Humanos , Cuidados Paliativos , Técnica Delphi , Avaliação de Resultados em Cuidados de Saúde , Delírio/epidemiologia , Delírio/prevenção & controle , Resultado do TratamentoRESUMO
OBJECTIVES: Providing optimal support for carers of people with advanced cancer is critical to facilitating discharge home from hospital. Carer Support Needs Assessment Tool-Intervention (CSNAT-I) has shown promise in supporting carers' needs in this context. This study aimed to explore patient and carers experiences with and views on the acceptability of the CSNAT-I delivered by occupational therapists in an acute oncology setting. METHODS: People with advanced cancer and their carers who had previously received the CSNAT-I as part of usual care while admitted to an Australian specialist cancer centre or acute hospital were invited to participate in interviews exploring their perceptions of the intervention. Data were analysed thematically. RESULTS: Two patients and 10 carers participated in semi-structured interviews. Three themes were constructed from the data: Carers viewed the CSNAT-I as comprehensive process that (1) 'covered everything' related to discharge planning; (2) generated an 'increased awareness of needs' for themselves, patients, and clinicians; and (3) triggered an emotional response of feeling 'wrapped up in care' that was maintained as they moved from hospital to home. CONCLUSION: This study has demonstrated that the CSNAT-I was highly acceptable to carers as part of existing discharge processes supporting them through the transition from hospital to home and can be delivered by occupational therapists and other clinicians with a natural synergy to discharge planning. These findings will inform further development and testing of the delivery model of the CSNAT-I in future trials.
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Neoplasias , Terapia Ocupacional , Humanos , Cuidadores/psicologia , Austrália , Pesquisa Qualitativa , Cuidados Paliativos/psicologiaRESUMO
Palliative Extended and Care at Home (PEACH) is a rapid response nurse-led package of care mobilized for palliative care patients who have an expressed preference to die at home. This study aimed to identify the demographic and clinical predictors of home death for patients receiving the package. Deidentified data were used from administrative and clinical information systems. Univariate and multivariate analyses were conducted to assess association of sociodemographic factors with mode of separation. Furthermore, 1754 clients received the PEACH package during the study period. Mode of separation was home death (75.7%), hospital/palliative care unit admission (13.5%), and alive/discharged from the PEACH Program (10.8%). Of participants with clear preference to die at home, 79% met their wish. Multivariate analysis demonstrated cancer diagnosis, patients who wished to be admitted when death was imminent, and patients with undecided preference for location of death were associated with an increased likelihood of being admitted to the hospital. Compared with those with spousal caregivers, those cared for by their child/grandchild and other nonspouse caregivers were significantly associated with a decreased likelihood of being admitted to the hospital/palliative care unit. Our results show that opportunities to tailor home care based on referral characteristics to meet patient preference to die at home, at individual, system, and policy levels, exist.
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Serviços de Assistência Domiciliar , Cuidados Paliativos , Criança , Humanos , Cuidados Paliativos/métodos , Papel do Profissional de Enfermagem , Cuidadores , MorteRESUMO
OBJECTIVES: Symptoms of raised intracranial pressure (ICP) in recurrent high-grade glioma (HGG) generally require corticosteroid treatment, often causing toxicity with variable effects on ICP symptoms. Acetazolamide reduces ICP when used in other clinical non-cancer settings. The aim of the study was to explore whether the addition of oral acetazolamide enables safe dexamethasone dose reduction in management of raised ICP in recurrent HGG. METHODS: Participants had recurrent HGG with any of dexamethasone recommencement, dose increase or dependency; prior/current bevacizumab was an exclusion. Eligible participants were randomised 1:1 to acetazolamide or placebo for 8 weeks. Standardised protocols were used for dexamethasone dosing, with planned dose decrease from day 5 once ICP symptoms were stable. The primary endpoint was a composite of dexamethasone dose reduction and stable Karnofsky Performance Status Secondary endpoints included toxicity and feasibility. RESULTS: Thirty participants (15 per group) were enrolled (mean age 58 years) from seven Australian sites. The mean baseline dexamethasone dose was 6.2 mg. Mean duration on study treatment was 38 days (placebo group) and 31 days (acetazolamide group) with nine participants (30%) completing all study treatments (six placebo, three acetazolamide). Study withdrawal was due to adverse events (n=6; one placebo, five acetazolamide) and disease progression (n=6 (three per arm)). Four participants (13%) (two per arm) were stable responders. Ten participants experienced a total of 13 serious adverse events (acetazolamide arm: five participants (33%), six events, two related). CONCLUSIONS: The study closed early due to poor accrual and increasing availability of bevacizumab. The addition of acetazolamide did not facilitate dexamethasone reduction. TRIAL REGISTRATION NUMBER: ACTRN12615001072505.
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Edema Encefálico , Glioma , Humanos , Pessoa de Meia-Idade , Acetazolamida/uso terapêutico , Edema Encefálico/tratamento farmacológico , Edema Encefálico/etiologia , Bevacizumab , Método Duplo-Cego , Recidiva Local de Neoplasia/tratamento farmacológico , Austrália , Glioma/complicações , Glioma/tratamento farmacológico , Dexametasona/uso terapêuticoRESUMO
Importance: Chronic breathlessness is common in people with chronic obstructive pulmonary disease (COPD). Regular, low-dose, extended-release morphine may relieve breathlessness, but evidence about its efficacy and dosing is needed. Objective: To determine the effect of different doses of extended-release morphine on worst breathlessness in people with COPD after 1 week of treatment. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled randomized clinical trial including people with COPD and chronic breathlessness (defined as a modified Medical Research Council score of 3 to 4) conducted at 20 centers in Australia. People were enrolled between September 1, 2016, and November 20, 2019, and followed up through December 26, 2019. Interventions: People were randomized 1:1:1 to 8 mg/d or 16 mg/d of oral extended-release morphine or placebo during week 1. At the start of weeks 2 and 3, people were randomized 1:1 to 8 mg/d of extended-release morphine, which was added to the prior week's dose, or placebo. Main Outcomes and Measures: The primary outcome was change in the intensity of worst breathlessness on a numerical rating scale (score range, 0 [none] to 10 [being worst or most intense]) using the mean score at baseline (from days -3 to -1) to the mean score after week 1 of treatment (from days 5 to 7) in the 8 mg/d and 16 mg/d of extended-release morphine groups vs the placebo group. Secondary outcomes included change in daily step count measured using an actigraphy device from baseline (day -1) to the mean step count from week 3 (from days 19 to 21). Results: Among the 160 people randomized, 156 were included in the primary analyses (median age, 72 years [IQR, 67 to 78 years]; 48% were women) and 138 (88%) completed treatment at week 1 (48 in the 8 mg/d of morphine group, 43 in the 16 mg/d of morphine group, and 47 in the placebo group). The change in the intensity of worst breathlessness at week 1 was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -0.3 [95% CI, -0.9 to 0.4]) or between the 16 mg/d of morphine group and the placebo group (mean difference, -0.3 [95%, CI, -1.0 to 0.4]). At week 3, the secondary outcome of change in mean daily step count was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -1453 [95% CI, -3310 to 405]), between the 16 mg/d of morphine group and the placebo group (mean difference, -1312 [95% CI, -3220 to 596]), between the 24 mg/d of morphine group and the placebo group (mean difference, -692 [95% CI, -2553 to 1170]), or between the 32 mg/d of morphine group and the placebo group (mean difference, -1924 [95% CI, -47â¯699 to 921]). Conclusions and Relevance: Among people with COPD and severe chronic breathlessness, daily low-dose, extended-release morphine did not significantly reduce the intensity of worst breathlessness after 1 week of treatment. These findings do not support the use of these doses of extended-release morphine to relieve breathlessness. Trial Registration: ClinicalTrials.gov Identifier: NCT02720822.
Assuntos
Dispneia , Morfina , Doença Pulmonar Obstrutiva Crônica , Medicamentos para o Sistema Respiratório , Idoso , Feminino , Humanos , Masculino , Preparações de Ação Retardada/uso terapêutico , Método Duplo-Cego , Dispneia/tratamento farmacológico , Dispneia/etiologia , Morfina/administração & dosagem , Morfina/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Medicamentos para o Sistema Respiratório/administração & dosagem , Medicamentos para o Sistema Respiratório/uso terapêutico , Doença Crônica , Resultado do TratamentoRESUMO
Objective: To ascertain palliative physicians' and consultation-liaison psychiatrists' perceptions of depression care processes in patients with very poor prognoses, exploring key challenges and postulating solutions. Methods: A qualitative focus group study involving three 1-h online focus groups (2 palliative medicine and 1 psychiatry) were conducted between November-December 2020. Fellows and trainees were recruited from Australian and New Zealand Society of Palliative Medicine (n = 11) and Royal Australian and New Zealand College of Psychiatrists (n = 4). Data underwent conventional qualitative content analysis. Results: Participants perceived depression care to be complex and challenging. Perceived barriers included: inadequate palliative care psychiatry skills with variation in clinical approaches; lack of supportive health infrastructure (poor access to required interventions and suboptimal linkage between palliative care and psychiatry); lack of research support; and societal stigma. Suggested solutions included integrating care processes between palliative care and psychiatry to improve clinician training, establish supportive health systems and promote innovative research designs. Conclusions: Developing clinician training, supportive health systems and innovative research strategies centering on integrating palliative care and psychiatry care processes may be integral to optimising depression care when providing care to people with very poor prognoses.