ANZCTR search results

The INJECT pilot feasibility study is comprised of a patient self-management psychological intervention to address needle distress in adults receiving haemodialysis foe end stage kidney failure. the intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of 6 learning modules which will provide strategies patients can apply to manage needle distress. There is also an option to use virtual reality (VR) technology as a distraction during dialysis. Patients will be supported by nurse practitioners and a research officer during the intervention. The goal is for patients to feel empowered in self-managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning. This structured and novel intervention enhancing patient self-management and empowerment represents a major advance in addressing needle fear and reducing this aspect of the psychological burden experienced by dialysis patients. It can be translated rapidly into clinical practice and may benefit other patients receiving frequent needles as part of therapy, for example for cancer. It is inexpensive and feasible to deliver across sites. Partnership with patients and nurses at all stages ensures the intervention is useful and successfully implemented into clinical care.

A randomized placebo-controlled pilot trial on palmitoylethanolamide (PEA) and curcumin for pain management in patients with chronic non-cancer pain. The overarching aim of this study is to evaluate the efficacy of a combined herbal/nutritional supplement for pain management and quality of life (QOL) indices for patients with chronic pain. Primary Objective • Evaluate the effect of combined PEA/curcumin capsules on pain management in patients with chronic pain in comparison to placebo. Secondary Objectives • Evaluate the effect of combined PEA/curcumin capsules on associated QOL parameters and daily functioning in patients with chronic pain in comparison to placebo. • Compare pain medication consumption between PEA/Curcumin group and placebo group • Evaluate safety of combined PEA/curcumin capsules with existing pain medication.

This study is investigating the feasibility of delivering salvage re-irradiation to the prostate gland in men who have previously received radiation. Who is it for? You may be eligible for this trial if you are a male aged 18 years or over, have previously treated been treated for prostate cancer with external beam radiotherapy or brachytherapy and have a local recurrence within the prostate, with no more than 5 distant metastases. Study details Participants will receive radiation to the prostate gland using Magnetic Guided adaptive radiotherapy on the MRI linear accelerator. The intervention is intended to be delivered as 5 radiotherapy sessions over 2 weeks. Participants will be asked to provide 9 blood samples throughout the study to assess the response to treatment. Data on toxicity and prostate specific antigen (PSA) response to treatment will be collected. Information from this study will be used to determine whether a MRI-guided approach to radiotherapy is a feasible clinical approach for the treatment of recurrent prostate cancer.

People with chronic pain frequently attending NSW Emergency Departments need access to support services that help them better manage in the community. The project will evaluate the effectiveness and value of a care coordination pathway called the Emergency Department Pain Management Pathway (ED PainPATH), to support people with chronic pain to better manage in the community, thereby reducing their need for Emergency Department care.

Smooth Sailing is a web-based mental health service for secondary school students developed at the Black Dog Institute in partnership with schools, school counsellors, students, parents, and health professionals. Smooth Sailing uses a website to register students, screen and monitor their mental health, allocate them to an appropriate level (or “step”) of care, engage them in youth-oriented evidence-based information and activities about mental health, depression, anxiety, and help-seeking, and connect them with a school counsellor when face-to-face support may be required. This trial aims to evaluate the effects of two different Smooth Sailing service enhancements (class allocation and incentive) on reach (operationalized as module completion). Another objective of this trial is to evaluate the effect of variations in reach on students’ help-seeking intentions and behaviours and mental health outcomes (depression and anxiety). We will also explore the effect of contextual factors on outcomes, and the barriers and facilitators affecting the implementation of the Smooth Sailing service.

This study is investigating the efficacy of assigning targeted therapy to Chronic Myelomonocytic Leukaemia (CMML) patients based on their individual molecular profile. Who is it for? You may be eligible if you are aged 18 years or over with a confirmed diagnosis of CMML with detection of TET2 and/or RAS pathway mutations during the genetic testing component of this study. Study details Participants will be assigned to each arm based on their individual molecular results: Arm 1: lenzilumab plus azacitidine (for participants with RAS-pathway mutations, or participants harbouring both TET2+RAS Pathway mutations) Arm 2: ascorbate plus azacitidine (for participants with TET2-only mutations) Each arm involves 24 cycles of treatment. Each cycle is 28 days. Participants who complete 24 cycles of active treatment will then enter the follow-up phase of the study where they will be followed up every 6 months for 24 months for survival, disease status and further CMML-related treatment. For participants who have confirmed progressive disease or relapse during the active treatment phase of the study, further treatment will cease. They will remain on study and be followed up for survival, disease status, and further CMML-related therapy every 6 months until 48 months from Cycle 1, Day 1. The results of this clinical trial will inform a rational targeted therapy management approach for a rare disease and will potentially be used to update clinical guidelines and inform healthcare providers.

Historically, CR has been delivered face-to-face to groups in acute hospitals or community centres. The content and length of CR programs varies considerably in Australia and national quality indicators are yet to be determined. Alternative methods for provision of CR have been shown to be effective but few have been implemented into practice. Therefore, we would argue that the evidence for strategies to modify risk factors is strong but the evidence for the mode of delivery has become outdated. The Country Heart Attack Prevention (CHAP) project will use a translation methodology combining a prospective case control designwith a Model for Large Scale Knowledge Translation, and comprehensive economic evaluation to implement evidence-based CR into rural and remote practice. The CHAP model includes; 1) endorsement of CR by clinicians 2) an auto-referral system, 3) a choice of mode of delivery, and 4) long term support for heart health from primary carers. In the 3 years of this study we will implement the CHAP model (Year 1) and evaluate the clinical and cost effectiveness (Year 2-3). We hypothesize that patients receiving CHAP will have higher rates of attendance and completion of CR; higher rates of risk factor modification higher rates of evidence base pharmacotherapy and experience lower rates of morbidity and mortality at 30 days and 12 months and the model will demonstrate cost effectiveness for both services and patients.

What is ASPiRATION? ASPiRATION is a clinical trial that is testing a new approach to providing personalised treatments for patients with newly diagnosed lung cancer through comprehensive genomic testing of patient’s tumour tissue. The ASPiRATION study is being conducted as part of a larger research project called the Molecular Screening and Therapeutics (MoST) Program. In Australia, standard of care tumour testing for lung cancer patients has the ability to identify changes in three genes: EGFR, ALK & ROS1, for which drugs are available on the Pharmaceutical Benefits Scheme (PBS). If a patient is suitable for ASPiRATION, their tumour will also be tested using a technique called comprehensive genomic profiling (CGP), often referred to as molecular screening and/or profiling. This technique allows to look at changes in hundreds of genes in a single test. After a patient’s tumour is tested, a report is sent to the referring oncologist with information on (i) Any genetic biomarkers that were identified in the tumour and (ii) The types of treatment that may be suitable. Who is it for? a. Adults (>= 18 years of age) with newly diagnosed pathologically confirmed non-squamous non-small cell lung cancer and sufficient tumour tissue for “molecular” testing b. Fit to be able to have treatment Study details: A small part of your tumour tissue, which was collected previously, will be used to identify a biomarker by doing a laboratory analysis (‘molecular screening’). You will be asked to provide information about your and your family’s health background, to donate a blood sample and complete some questionnaires. Results from molecular screening will be returned to all participants. These results may have implications for your treatment if a suitable biomarker is found. It is hoped this research will determine whether additional molecular screening can be feasibly integrated into Australian clinical practice for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC).

The primary purpose of the trial is to assess the feasibility of a scalable school-based physical activity intervention (known as Burn 2 Learn adapted) for students with disability. Teachers will be trained to deliver 2-3 weekly HIIT sessions (approx. 10 minutes) for a period of 2-months. We hypothesise that the intervention will be feasible for delivery in the school setting. Further, the intervention will be adapted from a previous intervention (Burn 2 Learn) to suit the needs of students with disability.

The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions in people with type 2 diabetes. We have found in one of our recent studies that quinine, given as a bolus in doses of 300 or 600 mg (in 10 ml water), potently slowed gastric emptying and lowered postprandial blood glucose. Moreover, we observed more potent blood glucose lowering effects when quinine was administered intraduodenally than intragastrically, suggesting that interaction of quinine with small intestinal receptors is required for potent effects. Therefore, based on these findings, this study aims to characterise the dose-related effects of intraduodenal quinine at these doses, on energy intake.