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Geriatric Assessment-Driven Interventions for oncology patients at Wollongong Hospital (GAIN-Woll)
Expand descriptionThe GAIN-Woll study aims to improve cancer care for older people by testing whether a simple geriatric assessment can better support treatment planning for patients aged 70 years and over with advanced cancer. Who is it for? You may be eligible for this study if you are aged 70 years or older, have advanced cancer where further treatment is being considered, be receiving treatment at Wollongong Hospital or the Illawarra Cancer Care Centre, and be able to communicate in English. Study details Participants who join the study will attend an appointment with a geriatrician at Wollongong Hospital within three weeks of enrolment. During this visit, they will complete a Practical Geriatric Assessment, which takes around 10 to 25 minutes and looks at areas such as physical function, nutrition, medical conditions, and daily activities. All participants in the study receive the assessment; there is no randomisation. Based on the assessment results, the geriatrician will develop a personalised management plan. This may include referrals to allied health services and discussions about future care planning. A short report summarising the assessment results is provided to the participant’s cancer doctor to help inform treatment decisions. Participants will be asked to complete the acceptability questionnaire at the end of the study, health conditions and compliance will be assessed from medical records. It is hoped that this research will show whether using this assessment improves cancer care planning and support for older adults with advanced cancer.
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A ZERO2 Sub-Project: Implementation Study of a Paediatric Oncology Medicines Database (ProCure) to Improve Access to Targeted Therapies
Expand descriptionProCure is a novel online paediatric oncology medicines access database, co-designed with paediatric oncologists and allied health professionals to streamline the application process for accessing targeted therapies. Accessing off-label drugs for children with cancer is often complex, and ProCure aims to address this challenge by providing a centralised, clinician-facing resource to support drug access applications recommended by the ZERO2 Molecular Tumour Board. This study builds on findings from the ALIGN study and will be conducted as a sub-study within the ZERO2 program of research. It will assess ProCure’s uptake by ZERO2 clinicians and its effectiveness in reducing clinicians’ time spent submitting applications, and evaluate whether implementation support improves the integration of ProCure in clinical practice. Who is it for? Eligibility is limited to paediatric oncology professionals (e.g., paediatric oncologists and oncology pharmacists) who are ZERO-affiliated and have had a patient enrolled in the ZERO2 study for whom access to an off-label targeted therapy may be required. Participants are actively employed as paediatric oncology professionals and therefore at least 18 years of age. No patients or carers will be recruited, as ProCure is a clinician-facing resource intended solely for paediatric oncology professionals. Study details Physical or informational materials that will be used in the intervention: All participants receive access to ProCure. ProCure contains drug profile information, examples of previous successful access, information on application and access pathways, and integrated tools that allow clinicians to contact and share access information with the Drug Access Navigator (DAN). In addition to accessing ProCure, participants in this arm receive a co-designed Implementation Support Package (ISP). The ISP was developed using findings from ProCure beta-testing and refined with input from paediatric oncology professionals to help clinicians use ProCure and integrate it into their routine clinical workflows. The ISP will be finalised during this trial. It may include components such as educational resources (tutorials, training, reminders, and support from 'super-user' groups) or other strategies to assist clinicians in using ProCure. Participants will take part in a focus group to finalise the ISP, and they will also complete surveys and interviews to provide feedback on their experiences using ProCure and the ISP. This will help us understand how well the ISP supports clinicians to use ProCure and how ProCure assists them in preparing applications for off-label medicines efficiently. It is hoped that the result from this study will improve the uptake of recommended therapies by reducing the time, complexity, and barriers involved in accessing off-label targeted therapies.
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Impact of withdrawing pholcodine cough medicines on serious anaesthetic allergy reactions in Western Australia
Expand descriptionPholcodine is an over-the-counter cough medicine that may increase the risk of severe allergic reactions to neuromuscular blocking agents (NMBAs) used during anaesthesia. In March 2023, all pholcodine-containing cough products were withdrawn from the Australian market. This study will use a prospectively approved and maintained Western Australian perioperative allergy registry to examine whether the withdrawal was followed by changes in the number of clinically investigated allergic reactions attributed to NMBAs, compared with reactions attributed to other drugs. Monthly counts of reactions from January 2016 to November 2025 will be analysed using interrupted time-series regression, focusing on level and trend changes at the time of the pholcodine withdrawal. No additional procedures, tests or changes to anaesthetic care are introduced as part of this study; it is a statistical analysis of existing clinical registry data.
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ALLG BM15: A Double-blind, Phase I/II, Randomised Study to Compare the Efficacy of Enzomenib Versus Placebo as Maintenance after Allogeneic Haematopoietic Stem Cell Transplantation in Subjects with Acute Myeloid Leukaemia (AML).
Expand descriptionWhat the study is about: This study will evaluate whether Enzomenib, a menin inhibitor, can reduce relapse risk when given as maintenance therapy after allogeneic haematopoietic stem cell transplantation in patients with acute myeloid leukaemia (AML). Who is it for: It is for patients aged 12 years or older with AML subtypes known to be sensitive to menin inhibition, including those with NPM1 mutations or KMT2A rearrangements, who will undergo an allogeneic haematopoietic stem cell transplantation. Study details: This is a double-blind, randomised Phase II trial comparing oral Enzomenib (up to 200 mg) with placebo for up to 24 months post-transplant. The first 20 participants will enter a safety run-in after atleast 2 cycles of Enzomenib treatment, before expanding to 170 patients across UK, Australian, and New Zealand centres. A target population of 53 will be recruited from the Australian and New Zealand centres. What is hoped from it: The study aims to determine whether Enzomenib can improve relapse-free survival compared to placebo, reduce the risk of disease recurrence, and provide a well-tolerated maintenance option after allogeneic haematopoietic stem cell transplantation for high-risk AML patients.
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Randomised clinical trial to survivorship in patients with cancer
Expand descriptionThe purpose of this study is to improve survivorship of cancer patients in relation with cardiovascular condition. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and have cardiovascular risks. Study details Participants will be randomised 1:1 to either intervention or usual care(control group). All participants will also be asked to complete an interview and assessments at baseline and be followed up for 12 months and optional 24 months which includes vital signs, blood tests, ECG, echocardiongram,and questonnaires. If the test results are available, we'll collect data through medical records, however it these are not available, participants are asked to do the tests. Intervention group will be seen by cardio-oncology team at least 3 monthly with additional care. It is hoped that this study will help improve survivorship in patient with cancer while minimising interruption of cancer therapy and cardiovascular risks and managing cardiotoxicity.
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Virtual Reality Nature for Neuropathic Pain Management: Application to People with Spinal Cord Injuries in Inpatient Settings
Expand descriptionThe purpose of this study is to evaluate the effectiveness of using VR Nature (nature scenes shown through virtual reality) to reduce pain and symptoms of psychological distress for people with SCI in inpatient contexts. We are predicting that after two-weeks of VR Nature, people will reduce in their pain, and also report a decrease in their symptoms of depression, anxiety, and stress.
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Testing the Feasibility and Benefits of Healthy Eating Plans for Improving Pain and Quality of Life in People with Osteoarthritis
Expand descriptionThis study aims to find out whether following a healthy eating plan that includes anti-inflammatory foods can help improve pain, quality of life, and health in people with osteoarthritis. Participants will be randomly assigned to one of two groups: one group will follow the Australian Dietary Guidelines (Healthy Diet A), and the other group will follow the same guidelines plus additional anti-inflammatory foods (Healthy Diet B). Both diets will be supported by regular sessions with dietitians over 12 weeks. The study will measure changes in pain, physical function, quality of life, mood, sleep, and blood markers of inflammation. We hypothesise that the group following the anti-inflammatory diet will experience greater improvements in quality of life, pain, and inflammation compared to those following the standard healthy eating plan.
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Web-based Period ImPact and Pain Assessment (PIPPA) screening impact study
Expand descriptionPeriod pain and symptoms impact many facets of young people’s lives. Early intervention in young people is critical to reducing the lifelong personal and societal impacts of period pain and symptoms and potential secondary causes such as endometriosis. However, problematically, young people do not know how to determine the normality of their menstrual pain, and the severity of impact that requires self management and help-seeking. Timely detection and early intervention for problematic period pain and symptoms may improve the health and wellbeing of young people. The purpose of this research is to conduct a randomised, controlled, three arm pilot trial to investigate the feasibility and acceptability of two web-based menstrual impact screening interventions compared with a control, in young people (14-25 years) with period pain and symptoms.
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Endoscopic Segmental Sealant Ablation (ESSA) Study - Evaluation of AeriSeal Polymer Sealant for Non-Valve Endoscopic Lung Volume Reduction
Expand descriptionEndoscopic Lung volume Reduction (ELVR) is an established treatment for severe Chronic Obstructive Pulmonary Disease (COPD). Endobronchial valves are an accepted management option for achieving lung volume reduction, but are not suitable for every patient. Over 50% of patients are unable to have one way valves because of anatomical deficits ('fissures') in the lobes of the lung. Patients with >95% fissure completeness are eligible for valves; patients with 80-95% fissure completeness are further assessed for possible valve options but currently in Australia, there are no therapeutic options for patients with fissure completeness < 80%. This study seeks to expand the ELVR technique to patients not suitable for ELVR with standard approaches (such as endobronchial valves) by using segmental delivery of a polymer foam sealant called AeriSeal ® in patients with a fissure completeness < 80% for the targeted lobe. Polymer sealant allows lung volume reduction in these COPD patients who have no other alternatives.
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Pilot testing a pain science education resource in real-world physiotherapy clinics.
Expand descriptionThis pragmatic pilot feasibility study evaluated the real-world implementation of PainPLaN, a co-designed pain science education resource, by physiotherapists in private practice settings with patients experiencing chronic or recurrent pain. The overarching aim of this study was to assess the feasibility, use, acceptability, satisfaction, and feedback on potential improvements for the resource, as reported by both physiotherapists and patients.