ANZCTR search results

This study is investigating cancer-related cognitive impairment, and the impact of a cognitive training intervention. Who is it for? You may be eligible for this study if you are aged 18 years or over, living in or near the Perth/Peel regions of Western Australia, and are currently undergoing any treatment for a confirmed diagnosis of cancer. This study also needs healthy controls; that is, people aged 18 years or over, living in or near Perth/Peel regions of Western Australia, with no cancer diagnosis and no history of any cancer diagnosis. Study details Participants will be asked to complete tests of memory, attention, executive function, and processing speed, as well as other psychological factors such as quality of life, sleep, anxiety, and pain. Biological markers implicated in neurogenesis will be assessed through blood tests, direct questions, and with reference to medical history. After which, researchers will contact you if you are eligible for the second part of the study. It is hoped that findings from this study will assist researchers with optimising daily oncology care.

Management guidelines for Low Back Pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation, and patient education. Our Royal Brisbane Womens Hospital Emergency Department (ED) audit revealed high rates of inappropriate medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepine). These medications are not recommended for LBP and have serious negative consequences (dependence, poisoning, death). We also observed high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation, and inadequate patient education. In RIME, we adapt, implement, and evaluate the only intervention shown to effectively reduce inappropriate medication prescription for LBP in EDs (Sydney SHaPED trial (ACTRN12617001160325); reduced opioid prescription by 12.3% sustained over 30 months). The adapted intervention uses a formalised clinical flow chart to support clinical decision-making and changes in clinician behaviour, bolstered by clinician education, provision of alternative treatments, educational resources, audit and feedback, and implementation champions. RIME is a controlled Interrupted Time Series study evaluating the adapted intervention in our RBWH ED pre- to post-implementation and will compare findings with a control ED in the same health district. The primary outcome is the proportion of LBP patients prescribed inappropriate medications, assessed via routinely collected record data. Total sample size is 2000 patients (n=1000 intervention, n=1000 control). Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, re-presentation to ED, healthcare costs. In nested qualitative research we will understand clinicians’ perceptions of the intervention and determine how benefits will be sustained benefits over time.

The primary objective of this project is to investigate psychological, cognitive and physiological changes associated with a single session of psychedelic drug exposure with psilocybin or 3,4-methylenedioxymethamphetamine (MDMA) in a group setting. Specifically, the study aims to use measures of psychological experience, cognitive function and electroencephalography (EEG) before and after psychedelic exposure. Secondary aims are (1) to assess changes in neural activity during acute substance exposure, (2) to determine whether tolerability is similar to previous studies, (3) to determine whether any pre-post differences we detect with the primary sample are replicated in a smaller sample who enter into a cross-over arm, taking the substance they did not take in the first instance, and (4) whether exposure to psychedelic drugs impacts self-assessed therapist competency. As both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to improve our understanding of the mechanisms of action of these drugs. In addition, this study will contribute to enhancing the delivery of psychedelic therapies by identifying whether psychedelic dosing in a group setting is associated with improved outcomes, and whether exposure to psychedelic medicines enhances clinical self-rated competency. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs, and how to apply them, as they transition towards broad scale implementation as therapies for psychiatric conditions.

This will be a phase 1 first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PTC607 at various incremental single doses in healthy volunteers.

Hip osteoarthritis (OA) is a prevalent public health problem with significant personal, social and economic costs. All clinical guidelines recommend education and physical activity, including structured exercise, in the management of hip OA, but undertaking regular exercise can be difficult for people with OA. Many people with hip OA are not receiving adequate advice or support required to incorporate regular exercise and physical activity into their daily routines. We are conducting a clinical trial to evaluate whether a digital exercise program ("My Hip Exercise"), in addition to an exercise adherence support mobile app, may be a scalable solution to overcoming barriers of exercise uptake in people with OA, compared with web-based education alone. The primary outcomes under investigation are hip pain while walking, and physical function. Participants will be randomly allocated to two treatment groups; i) Website comprising internet-delivered education, physical activity guidance and lower-limb strengthening exercise, combined with a mobile app to self-monitor and support exercise participation ii) Duplicated version of the website with internet-delivered education only Primary and secondary outcomes will be collected by web-based survey at baseline and 24-weeks after randomisation.

Critically ill patients in the Intensive Care Unit (ICU) frequently develop delirium. Delirium is extremely distressing to patients and is associated with poor outcomes. There are two forms of delirium, hyperactive and hypoactive (or a mix of both). The hyperactive form is particularly dangerous as patients may become aggressive and remove interventions that are essential for survival and/or injure themselves or staff. Given the urgency with which to treat hyperactive delirium, health care workers frequently administer potent antipsychotic medications to control delirium symptoms. However, we do not know if this is beneficial or harmful or if one antipsychotic medication is a better choice over the other. The purpose of this study is to compare the safety and efficacy (effectiveness) of the two most frequently prescribed antipsychotic medications (quetiapine and olanzapine) for hyperactive (agitated) delirium in critically ill patients.

Depression and apathy (feeling low and unmotivated) are common symptoms that accompany Parkinson’s Disease (PD). To date, few mental health programs exist to help people with PD experiencing these symptoms. The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program is a 6-session intervention that aims to alleviate depression and apathy by helping those with PD identify and engage in meaningful and enjoyable activities. The PD-GOAL program is grounded in principles of behavioural activation, an approach that has demonstrated to help people become happier around the world and that is also very effective in treating depression. Together with people living with PD and their support people, the Research Team previously adapted and co-designed the PD-GOAL program for people with PD. Our goal is to test whether the PD-GOAL program alleviates symptoms of depression and apathy in people with PD. We are also interested in opinions and general feedback on the program for future research.

National statistics from Australian sources predict normal-weight adults will comprise less than one third of the population by 2025. Evidence suggests there are synergies between obesity and type 2 diabetes mellitus (T2D). Insulin resistance is common in patients with obesity and results in a 7-12 fold increase in the risk of developing T2D. It is not unusual for patients attending the Metabolic and Weight Loss Program at our hospital to have large daily doses of insulin to manage their T2D. These patients often report fatigue, poorly controlled diabetes and difficulty managing their blood glucose level. Evidence from patients indicates lifestyle changes, psychosocial issues, insulin side-effects, dietary perceptions and a lack of confidence in diabetes self-care also influences blood glucose management. Evidence focused on support networks or education programs to improve self-management of T2D for obese patients is difficult to locate. The aim of this study was to determine whether group based education led to a reduction in diabetes distress when compared to usual care.

This is a prospective, non-randomised, cluster cross-over study of paramedic-led, multi-pronged, process of care re-engineering intervention. The intervention will include education, change in care pathways enabling patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST) supported by tele health technology to enable expert consultation where indicated. We will compare process of care times between the original and re-engineered process of care. This is a paramedic-led multi-pronged intervention including education, change in care pathway to enable patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST/MASS), supported by tele health technology to enable expert consultation where indicated. The aim of the study is to test whether implementing a paramedic-based patient bypass model supported by telehealth tools and patient assessments significantly improves the time to arterial puncture for thrombectomy treatment for participants with sufficient indications for such treatments.

The application of music as an intervention has a long history. Music intervention had rapidly developed and was introduced to healthcare settings in mid twentieth century. In clinical settings, music can be applied to alter mood and stress level, as well as to enhance immunity. Five-phase music therapy (FMT) is a modality of traditional Chinese medicine (TCM), which is a form of music intervention. For FMT, it was proven to have the potential of benefiting mental issues, such as depression, perinatal mental health, and improving the quality of life and symptoms of cancer patients. In addition, cultural background of the participants could affect the impact of music intervention. Cultural background of the participants is important to consider when conducting music intervention as it plays a crucial role in forming ones’ life perceptions, contributing to their presenting problems, and their responses towards music intervention. This study aims at evaluating whether TCM FMT can bring the same influence to people who are familiar with Chinese culture and those who are not. It is hypothesised that cultural background does not influence the impact of TCM FMT on mood and stress level. This can support the application of FMT in diverse cultural contexts. As this is a pilot study, this can also set as a foundation for future full-scale study with similar topics.