ANZCTR search results

This study aims to assess the feasibility of an online group exercise and education program for women with breast cancer who are receiving chemotherapy treatment. Who is it for? You may be eligible for this study if you are a female aged 18 or older, you have been diagnosed with early stage breast cancer (stage I, II or IIIA), you are scheduled to undergo chemotherapy but you have not yet started, or you have started chemotherapy within the last 4 weeks, and you have a reliable internet connection together with devices to enable video-conferencing. Study details All participants who choose to enrol in this study will undergo a 12 week exercise and education program that is delivered entirely by telehealth. Participants will attend two weekly exercise classes which run for 45 minutes and one educational class each fortnight, which runs for 1 hour including a 15 minute Q&A component. Exercise classes will include a combination of aerobic and resistance training exercises, while the educational sessions will cover topics including how to exercise safely while you are receiving chemotherapy, how to look after your mental health and strategies that may assist you, guidance on maintaining a healthy diet while you are receiving chemotherapy and after treatment has finished. Once this 12 week exercise program is completed, you will receive 12 weeks of tapered phone calls from the research assistant involved in this study to encourage you to maintain exercise levels. It is hoped this research will demonstrate that it is possible and acceptable to deliver these therapies to breast cancer patients remotely via telehealth. If this study shows that delivery of this program by telehealth is successful, it may lead to a larger future study of telehealth delivery of these therapies to a greater number of breast cancer patients, and would particularly benefit those patients who are not able to travel to hospital on a weekly basis.

The fundamental premise underpinning the research is that exposure to PAC, combined with genetic and lifestyle factors, creates chronic and systemic inflammation that underpins cardiometabolic conditions. The challenge is to demonstrate that decreasing exposure to PAC will reduce inflammation, and there are methodological issues to overcome. In this study, we will implement interventions to determine if removing putative sources of PAC exposure found in food and personal care products results in reduced excretion of PAC in urine. The interventions will be carried out in the participants’ homes with the support of registered dietitians under the supervision of a senior dietetic researcher. Sixty participants will be randomised into one of the following groups: Group 1: low PAC food only; Group 2: low PAC food + low risk utensils + low risk food preparation practices; Group 3: low PAC personal products only; Group 4: low PAC food + low risk utensils + low risk food preparation practices + low PAC personal products; Group 5: Control group. We hypothesise that this approach will demonstrate whether intervention A (low PAC ‘diet’) has an impact on urinary excretion of PAC (the response), whether intervention B (low PAC personal products) has an impact on the response, and whether there is any synergistic or antagonistic impact on the responses from combining the two interventions. That is, we will determine whether both intervention A and intervention B together provide a larger/smaller impact than the sum of the impact from each intervention alone. This design is statistically and economically efficient as it reduces the number of replicates needed and addresses many statistical hypotheses including the potential interactive effect of both interventions. The findings of this trial are expected to inform the optimal design for a future disease-focused randomised controlled trial testing the hypothesis that decreasing PAC exposure reduces risk factors for cardiometabolic disease.

This study will investigate the safety and efficacy of Tadalafil when given to women with an overactive bladder. We aim to investigate if women who receive this therapy have a decrease in urinary incontinence both during the day and night. All participants will receive six weeks of Tadalafil and six week of placebo in random order.

Transcranial magnetic stimulation (rTMS) has been established as a safe, effective and well-tolerated treatment for depression in patients who do not get better with other therapies. Although rTMS is an effective treatment, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to both enhance and accelerate treatment response including helping to develop the use of a novel form of rTMS, intermittent theta burst stimulation (iTBS), which can be applied in a far more efficient manner. The overall objective of this research is to try to maximize the number of patients who respond to treatment and to ensure that these benefits are achieved as quickly and as efficiently as possible. This project aims to optimise the application of TBS therapy by exploring the optimal dose and schedule of treatment.

Endoscopic surgical resection for early cancer of the oesophagus (involving insertion of a camera via the mouth rather than open surgery) is a widely accepted technique, allowing for complete removal of pre-cancerous tissue in this region. However this technique can lead to a narrowing or tighening of the oesophagus which may lead to difficulty swallowing and subsequent malnutrition. This study aims to investigate what effect injecting autologous (from your own body) fat cells into the surgical site has on the occurrence of oesophageal narrowing post-surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with Squamous cell oesophageal cancer, Barrett’s oesophagus with dysplasia or oesophageal intramucosal cancer and you are scheduled to undergo a surgical resection to remove cancerous tissue. Study details All participants who choose to enrol in this study will have approximately 20mls of fat tissue taken (as one sample) harvested from them prior to the procedure. Participants will then undergo the endoscopic surgery as planned, and these fat samples (following cleansing, approximately 2 - 5mls will be re-injected) will then be injected directly into the oesophageal tissue prior to the end of the surgery. The study investigators will follow up all participants for 3 months post-surgery to determine any adverse events or complications that may arise after the procedure, and will also assess swallowing ability and cancer recurrence. It is hoped this research will demonstrate that it is safe and technically feasible to inject autologous fat cells during an endoscopic oesophageal resection procedure. If this technique is found to be safe and shows signs of reducing oesophageal narrowing, a larger randomised study may be conducted at a later date which could provide a better quality of life for future oesophageal cancer patients.

This Research Project will be conducted in two parts. The first part will involve a randomised control trial of an online mindfulness training program (MTP) designed specifically for junior doctors, delivered to interns and resident medical officers working within Fiona Stanley and Fremantle Hospitals to assess the feasibility and effectiveness of the program with regards to reducing perceived stress and improving mindfulness, self-compassion and work engagement. The second part of the study will be qualitative in nature, involving an initial qualitative survey on junior doctor self-care strategies followed by interviews and focus groups with participating junior doctors to assess the underling factors contributing to their stress, as well as the barriers to and perceived benefits of participating in self-care strategies, including the online MTP. The MTP has been developed to include brief, daily mindfulness meditation practices and brief, weekly video teachings on the applications of mindfulness meditation for junior doctors. The program will be delivered via an online platform. This delivery mode aims to minimise the time required by busy junior doctors to invest in the program while providing stress management and self-care skills that are traditionally not taught as part of junior doctor training. The program will be evaluated using both quantitative and qualitative methods, including quantitative surveys before and after the program (part one) as well as qualitative data collection in the form of a pre-intervention survey and post-intervention interviews and focus groups (part two).

This study evaluates the safety and tolerability of the Suono 1 System, a low frequency ultrasound device intended to enhance mesalazine drug concentrations in colon tissue without increasing systemic (bloodstream) concentrations. Mesalazine is an approved therapeutic used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers on the inner lining of the large intestine. Patients with a UC flare are prescribed mesalazine enemas for daily use until condition improves. This preliminary study will assess safety and tolerability of ultrasound mediated mesalazine enemas in healthy participants. It is expected that ultrasound mediated mesalazine enemas will be tolerable and exhibit gross and cellular tissue appearance with no clinical significance.

“Approach bias modification” (ApBM) is a cognitive training task designed to reduce impulses to seek and consume alcohol. ApBM has been shown to reduce risk of relapse when delivered by computer during residential treatment for alcohol use disorder (AUD), but no previous studies have tested whether giving people access to ApBM via smartphone app that they can use after leaving rehabilitation treatment is also an effective way to prevent relapse. We have designed “AAT-App”, a smartphone app that incorporates ApBM training. We aim to conduct a randomised trial comparing the “active” version of AAT-App (which includes ApBM training) to a “control” version which also contains a cognitive task that is similar to ApBM but which (unlike ApBM) is not designed to change the mental processes that are believed to contribute to urges to seek and consume alcohol. We will provide AAT-App to participants when they discharge from residential rehabilitation. The app will send notifications prompting participants to complete the cognitive task and provide weekly reports of their alcohol use over a 4-week intervention period. We predict that participants who receive ApBM training will be more likely than those who receive the control version to abstain from alcohol during the intervention, and at 1-month, 3-month, and 6-month follow-ups after the end of the intervention. We also predict that they will have lower average alcohol consumption, less severe dependence on alcohol, less craving, reduced impulses to approach images of alcohol, and will be less likely to require readmission to hospital or residential treatment for AUD, as well as reduced depression, anxiety, and stress and improved quality of life and enjoyment of life.

This study will test the use of JettProof sensory singlets among children with a diagnosis of Autism Spectrum Disorder. The primary objective of this trial is to evaluate the effects of JettProof sensory singlets – applied for at least 6 hours/day for a three-week period – on the self-regulatory and motor functioning of autistic children. We hypothesise that application of the JettProof sensory singlet will lead to a reduction in autonomic and behavioural markers of affective and motor dysregulation and the subsequent attainment of individualized goals, relative to standard care. A second objective is to evaluate the effects of JettProof sensory singlets on additional outcomes related to sensory and motor functioning difficulties for autistic children and their caregivers. We hypothesize that, for children, the application of the JettProof sensory singlet will lead to a reduction in anxiety, less negative and more positive daily affect, and improvements in sleep quality for children and, for caregivers, a reduction in the levels of stress and perceived effort required to assist their children. A third objective is to assess the feasibility and acceptability of implementing JettProof sensory singlets with autistic children. We anticipate that most children will wear the singlet for 6 hours/day or more during the full-scale intervention phase, and report that it is at least tolerable. A fourth, exploratory objective is to determine whether there may be sensory characteristics of autistic children that predict differential response to JettProof sensory garments. We hypothesize that JettProof sensory singlets will evidence greater efficacy among children with a dysfunction in proprioceptive and/or vestibular sensory systems.

Myalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS) is a severe, chronic disease with an estimated prevalence of 0.76% in the Australian population. Post-exertional malaise (PEM) is the key symptom of ME/CFS which can last for several weeks or months, where patients have an exacerbation of symptoms (chronic fatigue, headaches, sleep disturbance, brain fog etc) following exertion, that cannot be relieved by sleep or rest. Simple everyday activities (such as walking and showers) can trigger PEM. Patients may face years of persistent symptoms including fatigue, PEM, sleep disturbance, impaired cognition, mood disturbance and muscle and/or joint pain. Despite the debilitating nature of its symptoms and high personal and socio-economic burden, there is no clear understanding of the underlying pathophysiology of the disease and no effective treatments . ME/CFS is a complex multisystem disease with potential involvement of the immune system, nervous system, and the musculoskeletal system in addition to nociception, mitochondria metabolism, and oxidative defence mechanisms. To be efficacious, potential treatments will need to target multiple systems and multiple processes to meaningfully impact quality of life. We believe that krill oil is a potential treatment option. Krill oil is a sustainable source of the long chain omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is also high in the antioxidant astaxanthin and the essential nutrient choline. EPA and DHA play critical roles in brain and metabolic function, in addition to being potent anti-inflammatory agents with analgesic properties. It is also known to improve cognitive and sleep quality. Choline plays an important role in the nervous system and energy metabolism while astaxanthin is a potent antioxidant proven to improve oxidative stress in humans. These compounds have systemic biological actions, and they have the potential to alleviate some of the systemic disruptions associated with ME/CFS such as brain fog, chronic pain and sleep disturbance resulting in reduced fatigue. Therefore, we propose that krill oil may be a viable treatment option for ME/CFS.