ANZCTR search results

This pilot trial will explore the feasibility and efficacy of an interprofessional outpatient treatment for anorexia nervosa and atypical anorexia nervosa. Interprofessional Enhanced Cognitive Behaviour Therapy (CBT-IE) is an adaptation of one of the leading outpatient eating disorder treatment models in which a dietitian and mental health professional deliver treatment collaboratively rather than being solely delivered by a mental health professional. Feasibility will be evaluated with regards to recruitment, retention, and attrition. Efficacy will be investigated with regards to weight restoration, eating disorder psychopathology, dietary intake, relationship to food, psychosocial functioning and team collaboration.

Obesity is the cause of profound health, psychosocial, and economic burden for affected individuals and the community (Wang, McPherson, Marsh, Gortmaker, & Brown, 2011). However, weight loss is notoriously challenging. Even the most intensive evidence-based programs often fall short in enabling people to sustain weight loss long term, with weight re-gain the most common pattern (Butryn et al., 2011). Several psychosocial barriers have been identified that make it particularly challenging for people with obesity to effectively achieve and sustain weight loss. These are: (1) substantial and pervasive weight stigma targeted at higher weight people (Haynes et al., 2018; Wu & Berry, 2018), (2) unsupportive social networks among people with obesity, both in general and for health behaviour change specifically (Puhl et al., 2021; Zwickert & Rieger, 2014), and (3) secondary to stigma and poor social networks, people with obesity are more likely to experience loneliness, and (4) mental ill-health (Jung & Luck-Sikorski, 2019), each of which exacerbate disordered eating (Levine, 2012). GROUPS 4 HEALTH (G4H) is uniquely suited to addressing these psychosocial barriers in order to facilitate weight loss and maintenance. Our study is a pilot trial of G4H to test its effectiveness in reducing these psychosocial barriers to health behaviour change and improving well-being among higher weight people (BMI 30+). The primary outcomes used to assess intervention effectiveness include loneliness, general mental well-being, and self-efficacy to achieve health goals. Secondary outcomes include social support, disordered eating behaviour, self-efficacy for physical activity, healthy eating and weight management, collective efficacy of therapy group to achieve health goals, depression and anxiety symptoms, self-esteem, social phobia, multiple group memberships, and social identification with therapy group, facilitators, and weight-related groups, and internalised weight stigma. We expect that participants who complete the G4H program will experience benefits in these outcomes that will be apparent immediately following program completion and at 2-months post intervention completion.

People who complete mindfulness or exercise programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a newly developed mindfulness and aerobic exercise program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. This program may go on to be used as a health and wellbeing program in the broader community.

Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with locally advanced pancreatic cancer (LAPC), Purpose of the study To investigate the safety of an active implantable (radiological) medical device called OncoSil, when implanted into patients with pancreatic cancer who are receiving standard chemotherapy, and to evaluate the response on the tumour after implantation. This will be compared to those who receive standard chemotherapy alone. Allocation to receive OncoSil treatment will be at the discretion of the investigator of the study, and your treating physician and oncologist. Study Details Participants that will receive the OncoSil treatment will undergo an Endoscopic Ultrasound, to accurately visualise the pancreas and assess tumour size. This will be performed under sedation and you are not likely to feel any pain during the process. The doctor guides the endoscope down the oesophagus, through the stomach and into the first part of the small intestine. The ultrasound is used to image the tumour in the pancreas. A fine needle is extended from the end of the endoscope into the pancreas and into the middle of the tumour. Once this needle is in an appropriate position within the tumour, a doctor will attach a syringe filled with OncoSil to the other end of the needle. The doctor will slowly depress the plunger of the syringe so that the contents of the syringe are implanted into the tumour, the OncoSil syringe is removed. Another syringe containing a small amount of saline (salt water solution) is attached to the needle. This will flush any remaining OncoSil from the needle into the tumour. The saline syringe is removed. The endoscope is removed by carefully pulling it back up the oesophagus and out of your mouth. Following implantation, you will be observed for a minimum of four hours and, if stable and pain-free, you may be discharged the same day. You will be required to attend two follow up visits with you study doctor, which will occur 4 weeks and 12 weeks after the OncoSil procedure. We hope this research will help provide further information on the safety and usefulness of this form of treatment for LAPC, and the results support further evaluation with larger trials.

The study aims to implement the ADAPT Portal and Clinical Pathway, which is a clinical pathway for managing anxiety and depression in cancer patients. This study also aims to evaluate the feasibility and acceptability of this pathway. Who is it for? If you are a cancer patient, you may be eligible for this study if you are aged 18 years or older, with any cancer, and are being treated at Lake Macquarie Private Hospital. If you are a cancer service staff member, you may be eligible for this study if you are aged 18 years or older, and employed on an ongoing or permanent basis at Lake Macquarie Private Hospital. Study details Cancer service staff will use the ADAPT Portal for patient registration, management and referral - including screening alerts. There will also be 5 x 45 minute Online Health Professional Education Modules, to be completed over a five week period. Patients will be able to log in to the ADAPT portal to complete screening, questionnaires, and access educational information at their discretion. There will also be online therapy treatment programs (involving 6-8 x 45 minute sessions over 10-12 weeks), available in the ADAPT Portal for patient self-referral or clinician referral. Cancer service staff will complete a survey before implementation and immediately after implementation to understand their experience with the ADAPT Portal. Immediately after implementation, cancer service staff and patients will also be interviewed on their experience with the ADAPT Portal. It is hoped that this study will provide evidence for how to effectively implement the ADAPT Portal and Clinical Pathway across private healthcare in Australia, and improve mental health for cancer patients.

The primary aim of this randomised controlled trial (RCT) is to compare the clinical and cost effectiveness of new generation peripheral intravenous catheter (PIVC) products with the standard care PIVCs. You may be eligible to participate in this trial if you are an emergency department patient more than the age of 18 and are requiring a peripheral venous catheter inserted as part of your therapy. All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PIVC options. This will be either the standard PIVC, or a PIVC with a retractable coiled guidewire. The allocated device will be kept from device insertion until the time of device removal. Participants and families will be asked to rate the satisfaction of the device, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PIVC devices are most effective in preventing first insertion failure.

International consensus for the level of disinfection required of ultrasound transducers used in percutaneous needle guided procedures is lacking. This study aims to quantify and compare the measurable differences in bacterial colony forming units identified on linear ultrasound transducers following both high- and low-level disinfection. The hypothesis is that reprocessing using low-level disinfection will be non-inferior in the elimination of bacterial contamination compared to a high-level disinfection. This research will be the first to directly compare the effectiveness of these two disinfection processes in a pragmatic study design aiming to answer this clinically important question affecting patients, staff, and organisations.

In line with iterative improvement approaches, a successive implementation intervention will be delivered in the same maternity services that participated in an initial practice change intervention trial in 2018-2019. The trial has two aims: 1) to increase the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption; and 2) sustain the rate of care provision over time. A three-month implementation intervention will be delivered. Three strategies will be used to support increases in the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption: remind clinicians; facilitation; and conduct educational meetings. Three strategies will be implemented to support sustain the rate of care provision over time: develop a formal implementation blueprint; purposely re-examine the implementation and conduct ongoing training. Cross-sectional data will be collected via telephone and online interviews with a random sample of women who attend the participating maternity services each week. The primary outcomes of the trial include: i) proportion of women that report being asked about alcohol consumption at subsequent antenatal visits; ii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at subsequent antenatal visits; and iii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at the initial antenatal visit. Intervention fidelity, penetration, acceptability and costs will be measured as secondary outcomes. A stepped-wedge controlled study design will be used to assess aim 1. It will determine whether the average proportion of women who received the recommended model of antenatal care for all three primary outcomes is higher post-intervention compared to pre-intervention. Aim 2 will use a multiple baseline design to assess whether the proportion of women who receive the recommended model of antenatal care increases and sustains following delivery of the implementation intervention.

The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in adult healthy volunteers of Chinese descent. Participants will be randomized in 1:1 ratio to 1 of 2 sequences. The ER tablet formulation will be used. Part C will enroll approximately 10 adult healthy volunteers of Chinese descent, defined as participants with both parents and both grandparents of Chinese ancestry.

The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in healthy volunteers. In Part B, participants will be randomized in 1:1:1 ratio to 1 of 3 sequences. The ER tablet formulation to be used in Part B will be selected from Part A. Part B will enroll up to approximately 12 adult healthy volunteers