ANZCTR search results

The purpose of this research is to examine the feasibility and acceptability of Baduanjin mind-body exercise for the management of cancer-related fatigue (CRF). Cancer-related fatigue is a persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment, and which interferes with a person’s everyday usual functioning in life. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older with cancer who is receiving adjuvant chemotherapy or has recently completed adjuvant chemotherapy who is suffering from moderate cancer-related fatigue. Study details Participants will be randomly allocated to one of two treatments: The intervention group will commence Baduanjin mind-body exercise program for 8 weeks (17-20 mins per session, twice a day for 6 days a week) starting at enrolment. The waitlist control group will continue without modifications to their usual care and undergo no Baduanjin mind-body exercise (however at the end of their waitlist, they are able to participate in the Baduanjin mind-body exercise program but not as a participant). As part of this study, both intervention and waitlist control groups will be asked to complete questionnaires at week 0 (baseline), week 4 (midpoint), week 8 (final week) and week 9 (1 week follow-up). It is hoped that the remote delivery of Badjuanjin mind-body exercise is a feasible home-based program for people with CRF.

This pilot study will assess the feasibility, acceptability and potential efficacy of a staff professional development intervention among Out of School Hours Care (OSHC) services to improve fruit and vegetable provision, child movement behaviours, and staff health promoting behaviours. A cluster parallel-group randomised controlled trial design will be used. The intervention will involve staff attending one three-hour professional development session, followed by four weeks of ongoing support. Investigators of the current project have been conducting a study to co-design an OSHC intervention with key stakeholders from the OSHC sector. Through this study, stakeholders were presented with findings from previously conducted before and after school care observational studies; and contributed to discussions around what support was needed to bring about meaningful change. The intervention to be piloted in this study is being developed through this collaborative process. It is hypothesised that OSHC services who participate in this intervention will increase their provision of fruit in before school care and vegetables in after school care. Children who attend these services will also have increased minutes of moderate-to-vigorous-intensity physical activity.

This is a 24-week pilot randomised controlled trial of a community-based cardiac rehabilitation (CR) program for Chinese migrants in Australia. A total of 24 participants will be randomly allocated in a 1:1 ratio to the intervention or waitlist control group. People in the intervention group will be offered a CR program virtually in entirety for 24 weeks, including health education via text messages, Shared Medical Appointment (SMA), and online live Tai Chi. Participants in the waitlist control group will be given no intervention during their wait period and will be encouraged to keep their normal lifestyle and physical activity. They will receive the same CR program after their wait period. The objectives of this project are: (1) To assess the feasibility of the co-designed community-based CR program for Chinese migrants in Australia of a wider trial by measuring its adoption rate. (2) To examine the effects of the co-designed CR program on improving health outcomes among cardiac patients from Chinese migrants in Australia. (3) To explore the cost effectiveness of the community-based co-designed CR program for Chinese migrants in Australia. The expected outcomes of this pilot randomised controlled trial include: • This pilot randomised controlled trial will quantify the feasibility, cost-effectiveness, and effectiveness of the co-designed, culturally sensitive community-based CR program. • The findings from this pilot trial will be interpreted as indicators of the potential value of a fully powered randomised controlled trial and other implementation and cost-effectiveness studies for CR among Chinese migrants in Australia and other western countries.

This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-2449 in participants with ovarian cancer. Who is it for? You may be eligible to join this study if you are aged greater or equal to 18 years and have been diagnosed with ovarian cancer. Study details: All participants in this study will be treated with a new investigational drug called APG-2449 in combination with a chemotherapy called Doxorubicin Hydrochloride Liposome (PLD). APG-2449 capsules will be administered to study participants orally once daily at a 28-day repeated cycles, 1200mg as the starting dose, and the dose level may be escalated to 1500mg or de-escalated to 900mg to determine the optimal dose level based on the safety observations, in combination with PLD 40mg/m2 intravenously infused on Day 1 of each 28-day cycle. More participants will be treated, once the optimal dose level of APG2449 identified, with APG2449 capsules orally daily in combination with PLD 40mg/m2 intravenously infused on Day 1 of each 28-day cycle. Participants will be closely monitored until they reach their study endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

Neuropathic eye pain (NEP) is a debilitating pain condition that is difficult to treat. NEP remains minimally responsive to existing pharmacological and non-pharmacological treatments. Although further studies are required to more definitively evaluate its efficacy as a treatment for alleviating NEP, there is growing evidence to suggest that electroencephalography (EEG) neurofeedback has the potential to reduce neuropathic eye pain. We have developed a novel EEG neurofeedback system to reduce NEP using openBCI technology, which incorporates the capturing and recording of EEG, and the delivery of neurofeedback via an interactive gaming interface. To achieve a reduction in NEP, we will use a neuromodulation protocol that targets and suppresses theta (4-8 Hz) and high beta frequency (20-30 Hz) power bands and enhances alpha (9-12 Hz) frequency power bands. A single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of our self-developed EEG neurofeedback treatment for the alleviation of NEP. Four participants with NEP will be recruited. Each participant will be randomly assigned to a different baseline phase (i.e., 7, 10, 13 or 16 days), which will then be followed by twenty 30-minute EEG neurofeedback sessions over a 4-week period. The Numerical Rating Scale will be used to assess average pain intensity, which will serve as the primary outcome measure. Pain interference will serve as the secondary outcome measure and will be measured using 6 items from the Brief Pain Inventory. Generalisation measures will be used to measure efficacy of the intervention beyond the primary and secondary outcomes and will assess quality of life, sleep quality, symptoms of anxiety and depression, mood and well-being. Satisfaction and feasibility of the intervention will be measured using self-reporting questionnaires and an unstructured interview. SCED trials are considered a viable alternative approach to randomised control trials when identifying evidence-based practices in the field of technology-based health interventions, when recruitment of large samples is not feasible.

Preliminary evidence shows that low-dose naltrexone (LDN) has a clinically beneficial impact on fibromyalgia pain, function and quality of life. However, only a few small clinical trials with high risk of bias have investigated the effect of LDN on fibromyalgia symptoms. The primary aim of this double-blind, randomised, controlled trial is to evaluate the efficacy of LDN in reducing pain in patients with fibromyalgia over a 12-week period.

People often have poor balance and trunk stability after they have a spinal cord injury, but the ability to maintain an upright position when sitting is important for their function. There is no gold standard assessment to measure this type of balance in people with an acute spinal cord injury. We plan to test three assessments (1. the Function in Sitting Test for people with spinal cord injury (FIST-SCI), 2. the modified FIST (mFIST), and 3. the Trunk Control Test (TCT)), used by physiotherapists in a clinical setting, and identify which assessments are the most valid and reliable assessments for people with acute spinal cord injury. Once identified, the researcher involved in this study will educated clinicians and other researchers on the best assessment to use, helping to improve clinical care and future research studies.

Maternal immunisation, a low cost/high efficacy intervention is recommended for its pathogen specific protection. We believe maternal immunisation has another, massive impact: reduction of preterm birth (PTB). Our overarching question is: how does maternal immunisation alter the immune system in pregnant women and/or their newborn to reduce adverse pregnancy outcomes and enhances the newborn infant’s capacity to protect from infectious diseases during early childhood? To answer this question and potentially impact on the single greatest cause of childhood mortality globally we are conducting a multi-site, prospective observational cohort study collecting maternal and infant biosamples at defined time points during pregnancy and post partum from nulliparous women. We plan to enrol 400 women and apply systems biology to determine the immune trajectory in pregnancy and the impact of maternal immunisation (including influenza, pertussis and/or COVID-19 vaccines) on this trajectory. We also plan to delineate the impact of maternal immunisation on the immune trajectory of the infant.

Introduction: You are invited to take part in this research project, Systemic fibrinolytic Activity of Intrapleural Alteplase in Pleural Infection. This is because you have a pleural infection (which means that fluid has collected around the lung and is infected) and you are to have Intrapleural Alteplase as part of your standard of care. The research project is aiming to test if a common treatment for pleural infection (Alteplase), will enter the bloodstream and circulate around the body after it is given into the pleural fluid. Purpose: The lung and the inside of the chest wall are both covered by a thin lining called the pleura. Under normal circumstances, this lining produces a very small amount of fluid to lubricate the lung during breathing. Sometimes there can be a build-up of fluid in the space between the pleural linings which gets infected, which is called a pleural infection. These occur in up to 50% of people who have pneumonia (infection of the lung), but are often very small and can’t be seen on a chest x-ray. In many cases, they clear up with antibiotics; less commonly, a chest tube is required to drain the fluid. Sometimes chest drainage is not enough to clear the fluid as a mesh of protein locks away the infected fluid in pockets which the chest tube may not reach. When these protein-pockets happen, people are said to have a complex pleural effusion. To help break down these protein-pockets, sometimes a medication called Alteplase is given through the chest tube. Alteplase has been proven to help people with pleural infection that also have complex pleural effusions, to get better and avoid surgery. It doesn’t appear to be absorbed into the body when given into the pleural space but this hasn’t been proven. We are doing this project to see if this is true or not. It is important to know if Alteplase given into the pleural space enters the blood-stream as it can cause bleeding in other parts of the body if this happens. What does participation involve: There is a list of criteria that must be met in order to participate in the study. The study team believe you meet the study criteria and that is why you have been approached about it. If you agree to the study, you will be participating in a prospective study. You will have 1 additional blood tests per dose of Alteplase compared to normal treatment, taking about 20mls of blood from your veins each time. This will be done 45 minutes after receiving Alteplase. The blood will be taken either by a lung specialist or a specialist nurse. If it is anticipated that there will be difficulty taking these blood sample, a lung specialist will acquire the blood with the help of an ultrasound machine.

This is a mixed methods prospective cohort study aiming to assess the impact of introducing a safety bundle for all operative vaginal birth (OVB) at Monash Health. This will include up-skilling obstetric staff in the use of intrapartum ultrasound, which they will be encouraged to use routinely prior to OVB. Additionally, we will introduce a routine team time out and procedural checklist to be performed at all OVB. We hypothesize that this bundle will reduce composite maternal and neonatal morbidity and mortality for women where OVB is considered during their clinical care. Secondarily we will assess uptake of all aspects of the bundle, rates of incorrect determination of fetal head position, unsuccessful instrumental birth attempts, mode of delivery and healthcare worker uptake and experience of the bundle. Our primary outcome is composite neonatal morbidity and mortality, which we will compare the 18months following safety bundle intervention to a historical cohort 18months preceding role out of the safety bundle.