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Background: The Stop Cancer PAIN Trial was a phase III pragmatic stepped wedge cluster randomised controlled trial which compared effectiveness of screening and guidelines with or without implementation strategies for improving pain in adults with cancer attending six Australian outpatient comprehensive cancer centres (n = 688). A system for pain screening was introduced before observation of a 'control' phase. Implementation strategies introduced in the 'intervention' phase included: (1) audit of adherence to guideline recommendations, with feedback to clinical teams; (2) health professional education via an email-administered 'spaced education' module; and (3) a patient education booklet and self-management resource. Selection of strategies was informed by the Capability, Opportunity and Motivation Behaviour (COM-B) Model (Michie et al., 2011) and evidence for each strategy's stand-alone effectiveness. A consultant physician at each centre supported the intervention as a 'clinical champion'. However, fidelity to the intervention was limited, and the Trial did not demonstrate effectiveness. This paper reports a sub-study of the Trial which aimed to identify factors inhibiting or enabling fidelity to inform future guideline implementation initiatives. Methods: The qualitative sub-study enabled in-depth exploration of factors from the perspectives of personnel at each centre. Clinical champions, clinicians and clinic receptionists were invited to participate in semi-structured interviews. Analysis used a framework method and a largely deductive approach based on the COM-B Model. Results: Twenty-four people participated, including 15 physicians, 8 nurses and 1 clinic receptionist. Coding against the COM-B Model identified 'capability' to be the most influential component, with 'opportunity' and 'motivation' playing largely subsidiary roles. Findings suggest that fidelity could have been improved by: considering the readiness for change of each clinical setting; better articulating the intervention's value proposition; defining clinician roles and responsibilities, addressing perceptions that pain care falls beyond oncology clinicians' scopes of practice; integrating the intervention within existing systems and processes; promoting patient-clinician partnerships; investing in clinical champions among senior nursing and junior medical personnel, supported by medical leaders; and planning for slow incremental change rather than rapid uptake. Conclusions: Future guideline implementation interventions may require a 'meta-implementation' approach based on complex systems theory to successfully integrate multiple strategies. Trial registration: Registry: Australian New Zealand Clinical Trials Registry; number: ACTRN 12615000064505; data: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspxid=367236&isReview=true. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Palliative care is characterised by heterogeneous patient and caregiver populations who are provided care in different health systems and a research base including a large proportion of observational, mostly retrospective studies. The inherent diversity of palliative care populations and the often inadequate study descriptions challenge the application of new knowledge into practice and reproducibility for confirmatory studies. Being able to define systematically study populations would significantly increase their generalisability and effective translation into practice. Proposal: Based on an informal consensus process by active palliative care researchers challenged by this problem and a review of the current evidence, we propose an approach to creating more comparable cohorts in observational (non-randomised) palliative care studies that relies on defining the study population in relation to a fixed, well-defined event from which analyses are built ('anchoring'). In addition to providing a detailed and complete description of the study population, anchoring is the critical step in creating more comparable cohorts in observational palliative care studies. Anchoring can be done with respect to a single or multiple data points, and can support both prospective and retrospective data collection and analysis. Discussion: Anchoring the cohort to reproducible data points will help create more comparable cohorts in palliative care whilst mitigating its inherent heterogeneity. This, in turn, will help optimise the generalisability, applicability and reproducibility of observational palliative care studies to strengthen the evidence base and improve practice. [ABSTRACT FROM AUTHOR]

Background: Breathlessness is a common symptom for palliative patients that can cause distress and decrease function and quality of life. Palliative care services in Australia aim to routinely assess patients for breathing-related distress, but timely reassessment is not always achieved. Objective:To improve the timeliness of breathlessness reassessment in a home-based community palliative care service in New South Wales for people with moderate-to-severe breathing-related distress. Breathing-related distress was defined as a Symptom Assessment Score for "breathing problems" of four or more. Methods: This collaborative quality improvement (QI) project between SPHERE Palliative Care CAG, Stanford University mentors, and a Sydney metropolitan specialist palliative care service included a: (1) retrospective chart audit; (2) cause and effect analyses using a fishbone diagram; (3) development and implementation of key drivers and interventions; and (4) a pre-and-post evaluation of the timeliness of reassessment of breathing-related distress and changes in Symptom Assessment Scale scores for "breathing problems." Results: Key interventions included multidisciplinary education sessions to facilitate buy-in, with nurses as case managers responsible for breathlessness reassessment and documentation of scores, access and training in electronic palliative care data entry software, fortnightly monitoring and reporting of breathing-related distress scores, and development of an educational flowchart. The proportion of patients reassessed within seven days of an initial nursing assessment of moderate-to-severe breathing-related distress increased from 34% at baseline to 92% at six months. Conclusion: A local QI project increased the proportion of patients with a timely reassessment of their breathing-related distress in a community palliative care service. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction The adoption of specialised geriatric oncology programs in Australia remains limited despite significant evidence supporting the benefits of comprehensive geriatric assessment, screening, and intervention for older adults with cancer. Multimorbidity and geriatric syndromes are highly prevalent among this population, and supportive services beyond cancer-specific diagnosis and treatment are critical to providing optimal cancer care. Innovative models are crucial to address this growing healthcare demand and disparities in cancer care for older people. Aim To implement and evaluate a nurse-led model of care for screening and assessing geriatric needs in older adults with lung cancer. Description A nurse-led geriatric oncology model of care was co-designed with key stakeholders including consumers. The model of care involved a nurse using validated tools to screen and assess all new patients with lung cancer aged 65+ or 50+ for Aboriginal and Torres Strait Islander peoples. Patients were subsequently discussed at a multidisciplinary team meeting with clinicians and allied health. Specific triggers identified patients needing a comprehensive geriatric assessment. Results Over six months, 58 patients were assessed by the nurse. The median age was 73 (range 65-86). 82% were seen prior to their first oncology treatment. All patients were discussed at the multidisciplinary team meeting. The most frequently reported issues were polypharmacy (45%), anxiety/depression (28%), mobility (19%), and cognition (19%). 88% of patients were referred to allied health and 33% referred for comprehensive geriatric assessment. 10% were referred to a geriatrician via their general practitioner. All patients received a follow up phone call within 4-6 weeks. Conclusion Innovative nurse-led models improve access to services for older people with cancer. This intervention provides workflow processes for delivering screening and assessment of geriatric syndromes which can be tailored to individual health services worldwide. Enabling this clear pathway of care, referrals and follow ups are increased. Ongoing evaluations focus on accessibility, feasibility and scalability. [ABSTRACT FROM AUTHOR]

Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.

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.

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.

Background: Hepatocellular carcinoma is a burdensome form of liver cancer with an increasing global prevalence. Emerging evidence has shown that early palliative care introduction at diagnosis of any life-limiting illness improves patient and carer outcomes. Despite this, patients with hepatocellular carcinoma usually receive palliative care late. These patients are important stakeholders in the provision of palliative care, but their perceived barriers regarding its delivery are poorly defined., Aim: This pilot study aimed to identify the barriers perceived by patients to integrating palliative care into the hepatocellular carcinoma treatment algorithm., Design: Patients living with hepatocellular carcinoma undertook semi-structured interviews about their perceptions of palliative care. We compared these perceptions before and after providing a brief explanation of palliative care. Interview data was inductively coded in NVivo 12 (2018) and thematically analysed., Results: Twenty-one patients were interviewed. 16 perceived palliative care to mean end-of-life therapy, and nine participants had no prior knowledge of palliative care. After hearing a definition of palliative care, 17 participants reported changed positive attitudes. Seven participants supported a name change, including four participants who continued to reject palliative care following the explanation due to the negative stigma associated with the term 'palliative care'., Conclusion: There is significant misperception about the purpose of palliative care among patients with hepatocellular carcinoma, constituting a barrier to early integration. This can be feasibly addressed with a two-folded educational and renaming initiative to dispel patient misconceptions regarding palliative care. Effective strategies to achieve this should be developed and tested with relevant stakeholders, particularly patients., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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.

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.