Decentralized Clinical Trials as a New Paradigm of Trial Delivery to Improve Equity of Access.

Importance: The need to maintain clinical trial recruitment during the COVID-19 pandemic has precipitated the rapid uptake of digital health for the conduct of clinical trials. Different terms are used in different jurisdictions and clinical contexts, including digital trials, networked trials, teletrials (TT), and decentralized clinical trials (DCT) with a need to agree to terms. Observations: This clinical care review summarized publications and gray literature, including government policies for the safe conduct of clinical trials using digital health. It compares 2 frequently used methodologies, DCT and TT, first developed before the COVID-19 pandemic by trialists and stakeholders in Australia to improve access to cancer clinical trials for geographically dispersed populations. TT uses a networked approach to implement clinical trials to share care between facilities and uses an agreement between sites or a supervision plan to improve governance and safety. Government regulators have adapted existing regulations and invested in the rollout of the TT model. The term DCT emerged in the northern hemisphere and has been the subject of guidance from regulatory agencies. DCT uses digital health to deliver care in nontraditional sites, such as participants' homes, but does not mandate a networked approach between health facilities or require a supervision plan to be in place. Conclusions and Relevance: TT can be considered as a specific type of DCT with several potential advantages, including upskilling across a network. DCT is a new paradigm for the use of digital health in the safe conduct of clinical trials and is a transformative issue in cancer care, addressing disparities in access to clinical trials and improving clinical outcomes.

"We're very much part of the team here": A culture of respect for Indigenous health workforce transforms Indigenous health care.

BACKGROUND: Improving health outcomes for Indigenous people by strengthening the cultural safety of care is a vital challenge for the health sector, both in Australia and internationally. Although Indigenous people have long requested to have Indigenous practitioners involved in their health care, many health services report difficulties with recruiting and retaining Indigenous staff. This article describes Indigenous workforce policies and strategies from two Australian health services, as well as cancer-service specific strategies. METHODS: Services were identified as part of a national study designed to identify and assess innovative services for Indigenous cancer patients and their families. In-depth interviews were conducted in a small number of identified services. The interviews from two services, which stood out as particularly high performing, were analysed through the lens of Indigenous health workforce. RESULTS: Twenty-four hospital staff (Indigenous and non-Indigenous), five Indigenous people with cancer and three family members shared their views and experiences. Eight themes were identified from the way that the two services supported their Indigenous workforce: strong executive leadership, a proactive employment strategy, the Indigenous Health Unit, the Indigenous Liaison Officer, multidisciplinary team inclusion, professional development, work environment and a culture of respect. Participants reported two positive outcomes resulting from the active implementation of the eight workforce themes: 'Improved Indigenous patient outcomes' and 'Improved staff outcomes'. CONCLUSIONS: These two cancer services and their affiliated hospitals show how positive patient outcomes and a strong Indigenous health workforce can be achieved when a health service has strong leadership, commits to an inclusive and enabling culture, facilitates two-way learning and develops specific support structures appropriate for Indigenous staff. It is hoped that the strategies captured in this study will be used by health services and cancer services to inform their own policies and programs to support building their Indigenous workforce.

Unmet supportive care needs among Indigenous cancer patients across Australia.

INTRODUCTION: Indigenous Australians with cancer tend to be diagnosed with more aggressive and advanced-stage disease, receive less treatment, have poorer survival and lower quality of life than other Australians. Reducing these inequalities requires an understanding of the supportive care needs of this cancer group. This study aims to describe the type and extent of unmet supportive care needs of Indigenous Australian cancer patients. METHOD: A multicentre, cross-sectional study recruited 145 Indigenous adults diagnosed with cancer in the previous 5 years in four Australian states and territories. Using a culturally specific tool, unmet needs were assessed in four domains: 'physical and psychological', 'hospital care', 'information and communication' and 'practical and cultural'. Moderate to high unmet need is that which requires some or a lot more help to be addressed. RESULTS: Two-thirds (65%) of patients reported at least one moderate to high unmet need and 20% of patients had moderate to high unmet needs with five or more items. Overall, patients most commonly reported moderate to high unmet needs in the physical/psychological (46%) and practical/cultural domains (34%), than the information/communication (23%) and hospital care domains (16%). More specifically, 'money worries' was the most frequently reported moderate to high unmet need (20%). CONCLUSION: Most Indigenous Australians living with cancer experience unmet supportive care needs. Physical/psychological and practical/cultural concerns were identified as priority areas for Indigenous cancer patients. These findings may inform priority areas for intervention towards optimal care pathways for Indigenous Australians diagnosed and living with cancer.

Unmet supportive care needs among people with cancer: A cross-cultural comparison between Indigenous and Non-Indigenous Australians.

OBJECTIVES: This study describes and compares the unmet supportive care needs between Indigenous and Non-Indigenous people with cancer. METHODS: Data from two cross-sectional supportive care needs studies were matched in a 1:1 ratio for Indigenous (n = 125) and Non-Indigenous (n = 125) Australian adults diagnosed with cancer. Descriptive statistics were used to compare type and prevalence of 24 need items measured by the SCNS-SF34 and SCNAT-IP. RESULTS: A higher proportion of Non-Indigenous participants compared to Indigenous participants reported having any moderate-to-high level of unmet needs (70% vs. 54%, p = 0.013) and the difference was consistently observed across non-matched characteristics. While concerns for caregivers, fear of recurrence and pain were central needs for both Indigenous participants and Non-Indigenous participants, there were some key differences in the specific unmet needs between groups. Physical issues including doing usual daily activities and dealing with fatigue were the top priorities for Non-Indigenous people, while money worries, dealing with psychological issues such as how to keep their spirit strong or hope about their future appeared to be priorities for Indigenous people. CONCLUSIONS: Variations in the unmet supportive care needs between Indigenous and Non-Indigenous people with cancer may guide health professionals to target specific needs when preparing care plans.

Long-term out of pocket expenditure of people with cancer: comparing health service cost and use for indigenous and non-indigenous people with cancer in Australia.

BACKGROUND: Indigenous Australians diagnosed with cancer have poorer survival compared to non-Indigenous Australians. We aim to: 1) identify differences by Indigenous status in out-of-pocket expenditure for the first three-years post-diagnosis; 2) identify differences in the quantity and cost of healthcare services accessed; and 3) estimate the number of additional services required if access was equal between Indigenous and non-Indigenous people with cancer. METHODS: We used CancerCostMod, a model using linked administrative data. The base population was all persons diagnosed with cancer in Queensland, Australia (01JUL2011 to 30JUN2012) (n = 25,553). Each individual record was then linked to their Admitted Patient Data Collection, Emergency Data Information System, Medicare Benefits Schedule (MBS), and Pharmaceutical Benefits Scheme (PBS) records (01JUL2011 to 30JUN2015). We then weighted the population to be representative of the Australian population (approximately 123,900 Australians, 1.7% Indigenous Australians). The patient co-payment charged for each MBS service and PBS prescription was summed for each month from date of diagnosis to 36-months post-diagnosis. We then limited our model to MBS items to identify the quantity and type of healthcare services accessed during the first three-years. RESULTS: On average Indigenous people with cancer had less than half the out-of-pocket expenditure for each 12-month period (0-12 months: mean $401 Indigenous vs $1074 non-Indigenous; 13-24 months: mean $200 vs $484; and 25-36 months: mean $181 vs $441). A stepwise generalised linear model of out-of-pocket expenditure found that Indigenous status was a significant predictor of out of pocket expenditure. We found that Indigenous people with cancer on average accessed 236 services per person, however, this would increase to 309 services per person if Indigenous people had the same rate of service use as non-Indigenous people. CONCLUSIONS: Indigenous people with cancer had lower out-of-pocket expenditure, but also accessed fewer Medicare services compared to their non-Indigenous counterparts. Indigenous people with cancer were less likely to access specialist attendances, pathology tests, and diagnostic imaging through MBS, and more likely to access primary health care, such as services provided by general practitioners.

Delays in lung cancer management pathways between rural and urban patients in North Queensland: a mixed methods study.

BACKGROUND: Despite advances in medical therapies, disparity in outcome between rural and urban patients remain in Australia and many Western countries. AIMS: To examine time delays in lung cancer referral pathways in North Queensland (NQ), Australia, and explore patients' perspective of factors causing these delays. METHODS: Prospective study of patients attending three cancer centres in Townsville, Cairns and Mackay in NQ from 2009 to 2012. Times along referral pathway were divided as follows: Onset of symptoms to treatment (T1), symptoms to general practitioner (GP) (T2), GP to specialist (T3) and Specialist to treatment (T4). Quantitative and qualitative methods were used for analysis. RESULTS: In total, 252 patients were participated. T1 was influenced by remoteness (125 days in Townsville vs 170 days for remote, P = 0.01), T2 by level of education (91 days for primary education vs 61 days for secondary vs 23 days for tertiary/Technical and Further Education (TAFE), P = 0.006), and age group (14 days for 31-50 years, 61 days for 51-70 years, 45 days for >71 years, P = 0.026), T3 by remoteness (15 days for Townville and 29.5 days for remote, P = 0.02) and T4 by stage of disease (21 days for Stage I, 11 days for Stage II, 34 days for Stage III 18 days for Stage IV, P = 0.041). Competing priorities of family and work and cost and inconvenience of travel were perceived as rural barriers. CONCLUSION: Remoteness, age and level of education were related to delays in various time lines in lung cancer referral pathways in NQ. Provision of specialist services closer to home may decrease delays by alleviating burden of cost and inconvenience of travel.

Quantifying Queensland patients with cancer health service usage and costs: study protocol.

INTRODUCTION: The overall mortality rate for cancer has declined in Australia. However, socioeconomic inequalities exist and the out-of-pocket costs incurred by patients in Australia are high compared with some European countries. There is currently no readily available data set to provide a systematic means of measuring the out-of-pocket costs incurred by patients with cancer within Australia. The primary aim of the project is to quantify the direct out-of-pocket healthcare expenditure of individuals in the state of Queensland, who are diagnosed with cancer. METHODS AND ANALYSIS: This project will build Australia's first model (called CancerCostMod) of out-of-pocket healthcare expenditure of patients with cancer using administrative data from Queensland Cancer Registry, for all individuals diagnosed with any cancer in Queensland between 1 July 2011 and 30 June 2012, linked to their Admitted Patient Data Collection, Emergency Department Information System, Medicare Benefits Schedule and Pharmaceutical Benefits Scheme records from 1 July 2011 to 30 June 2015. No identifiable information will be provided to the authors. The project will use a combination of linear and logistic regression modelling, Cox proportional hazards modelling and machine learning to identify differences in survival, total health system expenditure, total out-of-pocket expenditure and high out-of-pocket cost patients, adjusting for demographic and clinical confounders, and income group, Indigenous status and geographic location. Results will be analysed separately for different types of cancer. ETHICS AND DISSEMINATION: Human Research Ethics approval has been obtained from the Townsville Hospital and Health Service Human Research Ethics Committee (HREC/16/QTHS/110) and James Cook University Human Research Ethics Committee (H6678). Permission to waive consent has been sought from Queensland Health under the Public Health Act 2005.

Clinical profile and treatment outcomes of advanced neuroendocrine tumours in rural and regional patients: a retrospective study from a regional cancer centre in North Queensland, Australia.

BACKGROUND: Neuroendocrine tumours (NET) arise from neuroendocrine cells, which are widely distributed throughout the body. However, diagnosing NET is difficult due to nonspecific symptoms and the paucity of experience among health professionals. This retrospective study was carried out to improve our understanding about NET. This knowledge can be used for optimal utilisation and distribution of limited resources. AIM: To study the clinical profile, treatment and survival outcomes for advanced NET patients in Australian regional and remote settings. METHODS: We reviewed all adult patients who were diagnosed with NET between 1994 and 2012. Patients' data were extracted from electronic databases of The Townsville Cancer Centre. Remoteness was based on postcodes, with patients stratified as regional or rural North Queensland according to Australian Standard Geographical Classification (ASGC). Overall survival was studied using survival analysis. RESULTS: Data from 79 patients were included in the study. The median age at diagnosis was 60 years. A total of 48 patients (60.8%) was male and 31 (39.2%) female. The majority of the patients lived in rural areas (51, 64%) as compared to residing in regional areas (28, 36%). There were 34 deaths at the study cut-off point. Median overall survival of NET patients in rural areas is significantly less than those living in regional areas (1613 days vs. 2935 days, respectively), P = 0.03. CONCLUSION: Remoteness has an adverse impact on overall survival of NET patients. This outcome may be because of varied access to health services and/or lack of access to specialised scans and medical and surgical expertise.

Oncology service initiatives and research in regional Australia.

OBJECTIVE: This paper reflects on the recent growth of cancer research being conducted through some of Australia's rural centres. It encompasses work being done across the fields of clinical, translational and health services research. DESIGN: This is a collaborative piece with contributions from rural health researchers, clinical and cancer services staff from several different regions. CONCLUSION: The past decade has seen an expansion in cancer research in rural and regional Australia driven in part by the recognition that cancer patients in remote areas experience poorer outcomes than their metropolitan counterparts. This work has led to the development of more effective cancer networks and new models of care designed to meet the particular needs of the rural cancer patient. It is hoped that the growth of cancer research in regional centres will, in time, reduce the disparity between rural and urban communities and improve outcomes for cancer patients across both populations.

Timely access to specialist medical oncology services closer to home for rural patients: experience from the Townsville Teleoncology Model.

PROBLEM: Prior to 2009, the teleoncology model of the Townsville Cancer Centre (TCC) did not achieve its aims of equal waiting times for rural and urban patients and the provision of reliable, local acute cancer care. From 2007-2009, 60 new patients from Mt Isa travelled to TCC for their first consultation and their first dose of chemotherapy. Six of these patients required inter-hospital transfers and eight required urgent flights to attend outpatient clinics. Only 50% these rural patients (n = 30) were reviewed within one week of their referral, compared with 90% of Townsville patients. DESIGN: A descriptive study. SETTING: TCC provides teleoncology services to 21 rural towns; the largest is Mt Isa, Qld. KEY MEASURES FOR IMPROVEMENT: Specialist review of 90% of urgent cases within 24 hours, and 90% of non-urgent cases within one week of referral via videoconferencing. A 50% reduction in inpatient inter-hospital transfers from Mt Isa to Townsville. STRATEGIES FOR CHANGE: Employment of a half-time medical officer and a half-time cancer care coordinator, and implementation of new policies. EFFECTS OF CHANGE: Between 2009 and 2011, TCC provided cancer care to 70 new patients from Mt Isa. Of these new patients, 93% (65/70) were seen within one week of referral. All 17 patients requiring urgent reviews were seen within 24 hours of referral and managed locally thus eliminating the need for inpatient inter-hospital transfers. LESSONS LEARNT: Provision of timely acute cancer care closer to home requires an increase in the rural case complexity and human resources.

Cost savings from a telemedicine model of care in northern Queensland, Australia.

OBJECTIVE: To conduct a cost analysis of a telemedicine model for cancer care (teleoncology) in northern Queensland, Australia, compared with the usual model of care from the perspective of the Townsville and other participating hospital and health services. DESIGN: Retrospective cost-savings analysis; and a one-way sensitivity analysis performed to test the robustness of findings in net savings. PARTICIPANTS AND SETTING: Records of all patients managed by means of teleoncology at the Townsville Cancer Centre (TCC) and its six rural satellite centres in northern Queensland, Australia between 1 March 2007 and 30 November 2011. MAIN OUTCOME MEASURES: Costs for set-up and staffing to manage the service, and savings from avoidance of travel expenses for specialist oncologists, patients and their escorts, and for aeromedical retrievals. RESULTS: There were 605 teleoncology consultations with 147 patients over 56 months, at a total cost of $442 276. The cost for project establishment was $36 000, equipment/maintenance was $143 271, and staff was $261 520. The estimated travel expense avoided was $762 394; this figure included the costs of travel for patients and escorts of $658 760, aeromedical retrievals of $52 400 and travel for specialists of $47 634, as well as an estimate of accommodation costs for a proportion of patients of $3600. This resulted in a net saving of $320 118. Costs would have to increase by 72% to negate the savings. CONCLUSION: The teleoncology model of care at the TCC resulted in net savings, mainly due to avoidance of travel costs. Such savings could be redirected to enhancing rural resources and service capabilities. This teleoncology model is applicable to geographically distant areas requiring lengthy travel.

Disparity in cancer survival between urban and rural patients--how can clinicians help reduce it?

Many reasons for the disparity in survival of 5-7% between rural and urban cancer patients relate to government policies and funding issues. However rural healthcare workers, particularly medical practitioners, can make an impact on reducing this disparity with attention to factors such as reducing referral processing time, using telemedicine, and ensuring ongoing education of rural patients regarding risk factors and screening programs, among other strategies.