ANZCTR search results

The aim of this study is to examine whether new chemotherapy regimen, BrECADD is non-inferior to BEACOPP as first line treatment in advanced stage classical Hodgkin lymphoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have first histologically proven classical Hodgkin lymphoma at stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV. Study details Patients will be randomised in a 1:1 ratio to either 6 cycles of the escalated BEACOPP regimen (standard of care) or 6 cycles of the BrECADD regimen (experimental) . Treatment in both arms will involve intravenous infusions and oral tablets to be administered on specific days during the treatment cycle to deliver specific drugs in each treatment arm. Patients will receive treatment in 21 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent. Patients will be followed up for a period of at least 5 years after chemotherapy completion to assess progression free survival. It is hoped that this trial will determine if BrECADD is non-inferior to escalated BEACOPP as first line treatment in advanced stage classical Hodgkin lymphoma.

Psychosis is a debilitating neuropsychiatric syndrome characterized by delusions, hallucinations, disorganized thinking and cognitive and emotional disturbances. It is a defining characteristic of schizophrenia, and occurs frequently in other major mental illnesses such as depression and bipolar disorder. All current treatments for psychosis modulate levels of the neurotransmitter dopamine (DA), and it is thought that DA dysregulation within circuits linking frontal brain regions with a set of subcortical nuclei called the striatum (the so called frontostriatal circuits) is a final common pathway for the emergence of psychotic symptoms. Precisely how this dysregulation arises however, remains a mystery. This study will be the first to combine Positron Emission Technology (PET) measures of striatal DA function with functional Magnetic Resonance Imaging (fMRI) measures of frontostriatal connectivity to investigate the way in which altered subcortical dopamine may give rise to, or arise from, aberrant frontostriatal connectivity. The project has three specific aims: 1. characterise the direct relationship between PET markers of striatal DA function and fMRI measures of frontostriatal functional dysconnectivity; 2. determine whether striatal DA abnormalities are a cause or consequence of frontostriatal dysconnectivity; and 3. investigate the potential of these two phenotypes as clinical biomarkers by determining whether they can predict patients’ 12month clinical outcome. We will recruit 50 First Episode Psychosis (FEP) patients and 50 healthy controls to take part in the study. All participants will complete a clinical and brain imaging assessment at baseline. The brain imaging assessment will involve MRI and PET. FEP patients will additionally complete a clinical assessment after a 12 month followup period. No brain imaging will be conducted at this time. No followup of controls will be performed. During the followup period, the research staff will maintain regular contact with the patients' clinical team. Information on treatments will be acquired, enabling us to account for variations in treatment protocols in our analyses.

In children, acquired brain injury (ABI), and in particular traumatic brain injury (TBI), represents a common interruption to the course of normal development, with both international and local statistics citing an annual rate of 250–300 per 100,000 children (Kraus, 1995). Working memory refers to the capacity to temporarily store information for use in everyday activities (Alloway et al., 2006). Decision-Making is conceived as a complex interplay of high-level cold cognitive processes such as working memory, information processing, problem-solving, and hot emotional processes (Cassotti et al., 2011; Reimann and Bechara, 2010). Efficient working memory and decision-making abilities are essential as they underpin one’s performance in functional skill areas such as academic, adaptive, behavioural and social domains (Catroppa & Anderson, 2006; Ganesalingam et al, 2011; Gathercole et al., 2006; Mandalis et al, 2007; Muscara et al., 2008). Using a prospective, longitudinal design, adaptive abilities, behaviour, educational progress and everyday memory skills were investigated acutely post-injury and again at 12 and 30 months post-injury. Results suggested a strong association between injury severity and outcomes across all domains.With regard to social outcomes following childhood brain injury, deficits have been reported in many areas of social functioning and communication style, often resulting in low self-esteem, isolation, high rates of psychiatric disorder, criminal behaviour, and unemployment, and therefore poor integration into society (Anderson et al., 2009) The overall aim of the proposed study is to enhance working memory and decision-making abilities and therefore potentially strengthen academic, social, behavioural and improving quality of life for children and adolescents post traumatic brain injury (TBI). To achieve this aim, the objectives of the proposed study are: (i) To evaluate the effectiveness of Cogmed using a randomized controlled trial (RCT) to investigate improvements in working memory and decision-making, in children post-TBI, compared to children in an active control group. (ii) To determine whether these improvements in working memory and decision-making generalise into other areas of function and so also improve academic,social, behavioural, and quality of life outcomes. It is hypothesized that (i) Compared to children in the active control group, those children receiving Cogmed will display better working memory and decision-making skills immediately post-intervention and at 6 months post-intervention. (ii) Improvements in working memory and decision-making will result in improvements in functional areas such as academic, social, behavioural and quality of life outcomes.

The primary purpose of this trial is to evaluate the safety and efficacy of a Blinatumomab, Cytarabine (AraC) and Methotrexate therapy protocol for the treatment of acute lymphoblastic leukaemia. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 65 years, and have been newly diagnosed with B-precursor acute lymphoblastic leukaemia without Ph positive disease. Study details All participants enrolled in this trial will receive the same therapy protocol. This involves a 15-day debulking treatment with oral and/or intravenous vincristine followed by eight 28-day cycles alternating between intravenous blinatumomab therapy and intravenous methotrexate, methylprednisolone and cytarabine. After completing these alternating cycles, maintenance treatment will continue in 28-day cycles for 24 months with a combination of intravenous vincristine and oral prednisolone, mercaptopurine and methotrexate. Participants will be asked to complete questionnaires regarding their quality of life and will undergo assessments for disease progression, side effects and survival for 5 years.

In a novel approach we propose a randomised controlled trial to investigate the cognitive benefits of reducing prolonged sitting in adults aged 60 years and older with two risk factors for cognitive decline: being frail and not meeting physical activity guidelines. The 16-week theory-informed sitting reduction program will include one face-to-face session and five telephone calls. Participants will receive normative feedback on their objectively measured sitting time, work through a series of activities in a workbook and set goals which they will integrate incrementally. 144 older adults will be randomised to receive either the sitting reduction program or a control condition. Participants will be assessed at baseline, at end of intervention at 16 weeks and at 32 weeks to assess maintenance. Primary outcome is cognitive function assessed with the California Verbal Learning Test with secondary outcomes of objectively measured sitting time, executive function, mental wellbeing (anxiety and depressive symptoms, and quality of life), and body composition (waist circumference, weight, and % body fat) and sleep (duration and quality).

This study will explore the feasibility of delivering an online 6-week mindfulness-based intervention (MBI) to patients with increased risk of melanoma recurrence. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c, for which you have completed your last treatment within the past five years. You will also require access to the internet. Study details Participants in this study will be randomly allocated (by chance) to the 6-week online mindfulness based intervention (MBI) or usual care group. The MBI is designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; and (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness; (2) informal practice; and (3) formal meditation practice. Participants allocated to the usual care group will continue to receive their usual care for the first 6 weeks of the study, after which they will be offered the MBI. All participants will be asked to complete questionnaires assessing fear of cancer recurrence, worry, rumination, stress and mindfulness before and after the 6-week study period. Intervention adherence, meditation quality and home tasks will also be assessed weekly. If this intervention proves to be feasible, and trends for changes in outcome measures are observed, a larger randomised-controlled study will be planned to assess intervention efficacy and cost-effectiveness.

This project aims to address core goals of the National Palliative Care Strategy, by integrating specialist palliative care into aged care. The intervention is a new model of care: whereby specialist palliative care nurses will help facilities prioritise residents who have palliative care needs. The prioritisation will occur through ‘needs rounds’ which are staff-only meetings to discuss residents who may die in the next six months. Education to staff will also be provided. Following pilot work in 2014-5, this stepped wedge trial will seek to establish whether a new model of care will: 1. reduce length of stay in hospital, leading to significant cost savings 2. improve residents’ ability to die in their preferred place 3. improve care staff understanding of death and dying, and staff capacity 4. reduce symptom burden at end of life 5. reduces relatives' distress.

To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.

The aim of this study is to examine effectiveness of perampanel in the control of tumour associated epilepsy (TAE) in patients with grade II-III gliomas. Who is it for? You may be eligible to join this study if you are aged 18-65 years and have a diagnosis of World Health Organisation grade II-III supratentorial glioma and have experienced a pre-operative seizure. Study details Patients will be randomized (allocated by chance) to receive perampanel, or levetiracetam for 52 weeks. Doses will be escalated over the first four week before patients enter an assessment phase for the remainder of the trial. The primary outcomes are i) proportion of patients seizure free for 6 or more months in the assessment phase and ii) time to first post-operative seizure in the assessment phase. Secondary endpoints include measures of drug safety, tolerability and quality of life. Glutamate concentrations will be measured before drug treatment is commenced to assess whether it can be utilized to predict both post-operative seizure and response to perampanel. This will be the first monotherapy epilepsy RCT utilizing perampanel. A positive study would support a larger randomized phase III trial examining perampanel monotherapy in tumour associated seizures. The novel use of 7T MRI to quantify glutamate offers the opportunity to assess if a non-invasive biomarker can help stratify seizure risk and perampanel response. This can pave the way for individualised and targeted epilepsy treatment.

The aim of this study is to examine effectiveness of perampanel in the prevention of tumour associated epilepsy (TAE) in patients with grade II-III gliomas. Who is it for? You may be eligible to join this study if you are aged 18-65 years and have a diagnosis of World Health Organisation grade II-III supratentorial glioma and have not experienced a pre-operative seizure. Study details Patients will be randomized (allocated by chance) to receive perampanel, or or placebo for 16 week. Doses will be escalated over the first four week before patients enter an assessment phase for the remainder of the trial. Patients will be followed up for 52 weeks. The primary outcomes are i) time to first seizure after escalation phase (weeks 5-52) and ii) proportion of patients seizure free during 12 week assessment phase. Secondary endpoints include measures of drug safety, tolerability and quality of life. Glutamate concentrations will be measured before drug treatment is commenced to assess whether it can be utilized to predict both post-operative seizure and response to perampanel. This will be the first monotherapy epilepsy RCT utilizing perampanel. A positive study would support a larger randomized phase III trial examining perampanel monotherapy in tumour associated seizures prophylaxis. The novel use of 7T MRI to quantify glutamate offers the opportunity to assess if a non-invasive biomarker can help stratify seizure risk and perampanel response. This can pave the way for individualised and targeted epilepsy treatment and prevention.