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Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.
This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.
The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.
The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
Australia New Zealand registration number ACTRN12624000732583.
Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.
Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.
Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.
Geographical isolation compounds limited access to healthcare services and skilled workforce for the provision of rural aged care. Residents have complex chronic disease management and end-of-life care needs. An undersupply of general medical practitioners due to retirement, attrition or unfilled training places in Australia has impacted recruitment to rural areas. Nurse practitioners have been identified as a potential solution.
To describe and explore the inner (local and organisational) and outer (wider health system) contexts of healthcare, from the perspective of care staff and residents' families. This, in turn, aims to inform the planned implementation of a nurse practitioner model, in several aged care facilities, operating within rural and remote settings, in Queensland Australia.
A convergent mixed methods design.
Qualitative data were collected, in 2022–2023, using semistructured interviews with staff focusing on role, knowledge development, workplace culture and care relationships with local community. Resident's family's perspectives were obtained as a secondary analysis of organisational feedback data. Quantitative data were collected from direct care workers using the Alberta Context Tool for Long-Term Care. Data were analysed according to type and integrated.
Relational care for residents and families is highly valued but provision of quality is challenging where time-poor staff are perceived to be doing the best they can. Scarce local healthcare services make it difficult to meet resident healthcare needs. Despite the supportive organisational culture, evolving policy requirements have impacted already difficult staff recruitment in rural settings.
Identifying contextual needs of organisations in readiness for change highlights geographical and sectoral nuances influencing any future implementation. As government policy changes to improve the older adult care sector, rural and remote facilities are forced to increasingly adapt.
Context-specific needs extend far beyond a nurse practitioner providing additional expertise in care provision.
What problem did the study address? Nurse practitioners have been successfully implemented into residential aged care facilities in metropolitan and major regional centres but translating this role into rural and remote Australia requires being cognisant of the needs, unique challenges and context of this setting.
What were the main findings? In an organisational culture of support, the importance of staff providing relational care and having connection with older adult residents and families was a central driver. It was challenging for staff to meet complex care requirements in the absence of local healthcare options and support. Time pressures, from inadequate staffing and changing structural aged care sector, force the prioritising of care requirements.
Where and on whom will the research have an impact? Older adults, policy makers and aged care providers will benefit from understanding the context of rural and remote settings, particularly in identifying potential solutions when there are gaps in primary and secondary healthcare.
The GRAMMS checklist was followed in reporting of this study.
Two lived experience consumers were involved as research team members. One was involved during the development and submission of the funding application and another during project activities including data collection and analysis and the development of publications.
People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.
Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.
The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.
This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.
This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).
Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.
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