ANZCTR search results

The current project aims to assess the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters. Approximately150 male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be randomised into three groups and assessed on their drinking behaviour, physical activity, and diet at the start of the study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters.

This study will investigate the effectiveness of durvalumab in combination with standard chemotherapy for mesothelioma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have had a diagnosis of malignant pleural mesothelioma that is not amenable to curative surgical resection. Study details All participants in the study will receive standard first-line chemotherapy for mesothelioma and the new treatment, durvalumab, intravenously on day 1 of each 3 week cycle for a maximum number of 18 cycles. Participants will be followed-up for a minimum of 12 months to determine progression free survival and tumour response rate. Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called PD-L1. Blocking PD-L1 helps the body’s immune system to attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. We plan to enrol 54 participants in this study from hospitals and clinics throughout Australia. Durvalumab is currently an experimental treatment. This means that it is not yet approved for the treatment of mesothelioma, or any other condition, in Australia, or in other countries.

The randomised controlled trial aims to evaluate the impact of a three-part television documentary on men. The documentary was designed to improve men's wellbeing by reducing their conformity to traditional masculine norms (e.g., being stoic, ‘toughing it out’, coping alone) that have been shown to be associated with reduced likelihood of help seeking and poor mental health outcomes. Before viewing the documentary adult male participants will complete a baseline regarding participants’ demographics, intentions to seek help, masculinity, gender role conflict, social support, resilience, psychological distress, suicidality and well-being . They will be then randomly allocated to either view the study documentary (intervention) or view an unrelated documentary (control) and emailed a web link to the documentary so that they can watch it at home. Immediately after viewing they will be asked a few questions about their impression of the documentary, also online (Time 2). Four weeks after viewing the documentary they will again be asked to complete an online questionnaire via email (Time 3). This final questionnaire will repeat the baseline measures and will also ask for some qualitative feedback regarding the documentary. The study hypothesizes that participants who watch the documentary will show increases in their intentions to seek help, whilst also demonstrating reductions in negative attitudes related to masculinity, suicidal thoughts and psychological distress, and increases in their use of social support, resilience, and well-being when compared to participants who watch an alternative documentary.

National Heart Foundation guidelines recommend long-term statin therapy in several major patient groups, but adherence rates are low, even following life-threatening events such as acute coronary syndrome. Muscle-related symptoms are the most commonly reported reason for statin discontinuation and about 1 in 5 patients taking statins report some degree of muscular pain. Placebo-controlled trials indicate overall in a treated population most symptoms are not due to the statin, but for an individual patient it is typically impossible to be certain. N-of-1 (single-patient multiple crossover) trials offer a simple, intuitive way to resolve this uncertainty. While N-of-1 trials have been used for more than 20 years, to date, few clinical services in Australia are conducting N-of-1 trials on a regular basis to improve the management of individual patient. Fewer studies have looked at the potential of using N-of-1 trials to determine statin tolerability. A recently published study suggested that N-of-1 trials can improve the assessment of statin-related myalgia in selected patients from endocrinology clinics in Canada. However, the results were limited by its small sample size and the potential for expanded use of N-of-1 trials to improve the compliance of statin therapy among statin intolerant patients remains unclear. The study will include up to 15 N-of-1 trial participants. Patients with prior history of intolerance of both atorvastatin 10 mg AND rosuvastatin 5 mg monotherapy, had statin-related myalgia occurring within three weeks of starting statin therapy and consequently discontinued statin use will be invited to participate. Each person will go through 3 double-blind, crossover comparisons of statin versus matching placebo. Each treatment and control period will last for 3-weeks and there will be a 3-week placebo wash out period after each of the active statin treatment. The total trial period for each participant will be 27 weeks. Myalgia scores will be recorded on a weekly basis during the study period. Brief Pain Inventory Questionnaire will be completed and blood sample collection will be done at baseline and at the end of each active treatment and control period to measure serum CK, ALT, AST, FGF21 and creatinine levels. To avoid unblinding of treatment allocation during the trial period, additional blood samples will be stored to measure lipids’ levels upon study completion. Genotype analysis will also be done at the end of the study to determine if genotype is associated with statin-induced myalgia.

Over 7 million Australians are living with a chronic conditions that cause more than half of all preventable hospital admissions. Once people leave hospital only about 50% adhere to prescribed medicines and at best 30% achieve lifestyle change. Simple strategies to improve ‘out-of-hospital’ management and support are needed. Text messaging has been shown to be effective and simple and is supported by quantitative and qualitative evidence led by CIs who have developed text message programs that promote lifestyle change. At the same time, Sydney Local Health District (LHD) has a text message system for contacting and following-up patients with chronic disease. However, these programs are not linked and in this research we will expand, refine and integrate our existing message programs then test and examine implementation. We propose a 3 phase project combining implementation science, a pragmatic trial, qualitative research and stakeholder engagement with appropriate ethical approval and following CONSORT guidelines. Phase 1 will see expansion of existing software and message content. Phase 2 is a pragmatic randomised implementation trial (n=310) with clinical and cost-effectiveness outcomes coupled with a process evaluation to inform scalability and implementation across settings. Phase 3 is a post-implementation assessment of success and challenges: to enable refinement of program content and features so as to maximise future success and ensure scalability.

The primary purpose of this trial is to evaluate the efficacy of oral testosterone for the prevention and treatment of sarcopenia in men with prostate cancer on Androgen Deprivation Therapy (ADT). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer, for which you are undergoing ADT. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either oral testosterone once per day for six months, or to receive an inactive sham tablet once per day for six months. All participants will be reviewed for sarcopenia by assessment of muscle mass with DEXA at six months, and for prostate cancer progression by PSA. It is hoped that the findings from this trial will provide information on the efficacy of oral testosterone for the prevention of sarcopenia in patients commencing ADT and the reversal of sarcopenia in patients on long term ADT, whilst evaluating whether this treatment has any impact on prostate cancer progression.

This is a first in human phase 1, randomized, blinded, placebo-controlled single-centre, dose escalation safety and tolerability study that will evaluate 5 doses of FDY-5301 by sequentially increasing the dose of intravenous FDY-5301

The primary purpose of this trial is to evaluate the safety and efficacy of KappaMab in combination with Lenalidomide and Dexamethasone for the treatment of relapsed/refractory multiple myeloma. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over with relapsed/refractory kappa restricted multiple myeloma for which you have received Received 1-3 prior lines of therapy. Study details Half of the participants in the study will be administered KappaMab only and half will be administered with KappaMab in combination with Lenalidomide and Dexamethasone. KappaMab will be administered weekly for the first eight weeks of study and every 28 days therafter. Lenalidomide will be taken for the first 28 days of study and the first 21 days of cycle 2. Dexamethasone will be taken weekly for the duration of the study. Participants will have blood samples taken once per month along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of a KappaMab and Lenalidomide based immune-oncology approach for the treatment of multiple myeloma patients relatively early in their disease course.

HYPOTHESIS – That a psychology based obesity intervention in a GP setting will result in sustainable improvements in both QOL (quality of life) of overweight, obese & morbidly obese patients and result in improvements in measurable outcome parameters such as reduced visceral fat, improved blood sugar, lipids and fatty liver.

The proposed project will evaluate the feasibility of using pedometers as a motivational tool to improve mobility outcomes in inpatient rehabilitation. All eligible patients on the rehabilitation ward will be invited once they are able to walk with or without the assistance of one person, with our without a gait aid for a minimum of 3 metres. All participants will be provided with a pedometer for the duration of their stay. Those in the pedometer intervention arm will record daily step counts and be encouraged by staff, family and friends to take more steps each day. Those in the control arm will wear pedometers fixed shut and will be encouraged to walk further each day. Mobility outcomes will be measured at two points, before allocation and discharge from the ward. Pedometer usability by participants will also be evaluated.