ANZCTR search results

The purpose of this study is to determine the effect of an online yoga exercise on mental health in women diagnosed with breast or gynaecological cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, with diagnosis of breast/gynaecological cancer within the last 5 years. Study details Participants in this study arm are randomly allocated (by chance) to one of two groups: 1. 60 minute online group yoga class weekly, for 6 weeks 2. 60 minute individual yoga class weekly, for 6 weeks Participants will complete a number of questionnaires at the end of the 6 week intervention period. It is hoped that this research will help to determine whether an online yoga class will improve mental health in people diagnosed with cancer.

The aim of this project is to document over a period of a six-month period the post morbidity problems including pulmonary, functional, neurocognitive and health related quality of life for those patients infected with COVID-19. Results will be compared between severity levels of the infection (mild, severe and critical) and adjusted for the premorbid age adjusted Charleson Comorbidity Score. It is hypothesised those subjects with a positive diagnosis of COVID -19 will have abnormal results when compared to population norms in pulmonary function, functional ability, neurocognitive status and health related quality of life.

The project will examine workplace stress experienced by aged care workers. The experience of stress may cause physiological changes in immune and hormonal systems, and these changes can affect our mental and physical health. The project aims to extend the knowledge of the relationship between workplace stress, turnover intentions, and physiological markers of stress: salivary cortisol, salivary alpha-amylase (sAA), and secretory immunoglobulin A (sIgA). Using a waitlist control design, participants will engage with a mindfulness smartphone intervention for three weeks. It will establish the relationships between mindfulness, stress and pre-clinical markers of diease. Participants will provide saliva samples and complete questionnaires at three time-points: pre-intervention, post-intervention, and 2-months post-intervention. This information is important as it will improve our understanding of the effects of workplace stress on the immune and hormonal systems and self-reported intentions to leave a vocation..

Concussion is the most common form of brain injury, making up 75-90% of all brain injuries. Concussions generally resolve within 7-10 days, however, up to 25% experience delayed recovery which may interfere with return to pre-injury activities (e.g. work) and cause significant stress for months and sometimes years after injury. Persisting concussion symptoms are thought to reflect a range of factors beyond the original injury to the brain including stress and anxiety and physical factors such as injury to the neck, visual and/or balance systems. Given that multiple factors may be contributing to the persistence of symptoms after concussion, an interdisciplinary approach to management is now recommended in clinical practice. Therefore, we aim to evaluate an interdisciplinary intervention that incorporates expertise from psychology, physiotherapy, and medicine to target the primary factors thought to contribute to persisting concussion symptoms. As part of our interdisciplinary intervention, participants with persistent concussion symptoms will be offered 8 sessions each of psychological and physiotherapy treatment over 12 weeks as required based on the initial interviews (face-to-face or Telehealth). Medical management of persistent post-concussion symptoms will comprise of one consultation with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school).

Prostate cancer is the most commonly diagnosed cancer in Australian men. PSMA PET-CT (“prostate specific membrane antigen positron emission tomography computed tomography”), or “PSMA PET” for short, is increasingly being used for the imaging of prostate cancer. For this imaging technique, PSMA (prostate specific membrane antigen) is bound to a small amount of a radioactive imaging tracer. Two different imaging tracers are available in Western Australia, based on Gallium 68 (Ga 68) and Fluorine 18 (F18) compounds. This purpose of this study is to: • Evaluate the consistency of PSMA PET scans when the same type of scan is repeated within a short time frame (approximately one week). • Compare results of a Ga68-PSMA PET scan with results from a F18-PSMA PET scan, when both are performed within a short time frame (approximately one week apart). Who is it for? You may be eligible for this study if you are a male aged 18 or older and have been diagnosed with metastatic prostate cancer, you have not had a change in your cancer treatment in the last 12 weeks and have been referred by your treating physician to have a PSMA PET scan. Study details All participants in this study will have one additional PSMA PET within 2 weeks of the first scan. You will be allocated to receive either two Ga68-PSMA PET scans, two F18-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). At each scan you will have one of the radioactive tracing agents injected into your arm, followed by a 1-2 hour wait before the scan is performed. You will then be positioned on the bed of the scanner to get PET and CT pictures of your body from head to thighs. The time in the scanner is around 20 minutes. In total, participation in the study will involve one additional visit to hospital in order to have a second PSMA PET. The time required for this visit will be 2 – 3 hours after which time you can return home without further assessments.

A range of challenges faced by children and adolescents with asthma contribute to their increased experience of psychological distress and lower quality of life than peers without asthma. Psychological interventions such as cognitive and behavioural therapies (CBT) may provide young people with techniques and strategies to manage symptoms of psychological distress and therefore symptoms of asthma, to avoid exacerbations. However, reports indicate low uptake of psychological intervention in this age group, with youth preferring to seek help themselves via internet sources. To improve access to and uptake of evidence-based treatments for elevated psychological distress in adolescents (aged 13-17 years) with asthma, this project will evaluate mixed reality technology (augmented reality, virtual reality, holographic technology) as a delivery mechanism for a component of CBT. Development of mixed reality tools will be guided by a comprehensive protocol for health program development, with direction from experts in Design, Information Technology, Respiratory Medicine, and Psychology. The acceptability of these technologies for use by youth, their parents/guardians, and health professionals will be explored through qualitative research via one-on-one interviews. This study will provide essential pilot data to guide development of a fully powered randomised controlled trial.

The BALANCE study is a randomised clinical trial comparing 7 to 14 days of antimicrobial therapy for bacteraemia. This sub-study is designed to determine whether patients enrolled in the main study, with a urinary source of their bacteraemia (urinary sepsis/urinary-tract infection), are as likely to be cured from their urinary-tract infection when treated with a short duration (7d) antimicrobial therapy, as compared with a longer duration (14d) of therapy. Demonstrating a clinical cure of the primary source of infection is important in UTI. If microbiological cure of the infection is not achieved, patients remain at increased risk of recurrent urinary tract infection and sepsis. If the BALANCE study demonstrates non-inferiority of 7 days duration antimicrobial therapy, further data supporting non-inferiority of cure for UTI will enhance the generalisability and clinician acceptance of reduced duration antimicrobial therapy.

Anorexia nervosa (AN) is a serious, debilitating psychiatric disorder, with numerous physical and psychological health impacts (Lock, 2012; Katzman, 2005). Typically diagnosed in young people, individuals with AN are 12 times more likely to die and 57 times more likely to commit suicide compared to same-age peers (Keel et al., 2003). Illness duration may extend to over 20 years for more than half of those afflicted (Fichter et al., 2017), highlighting marked chronicity. It is essential that evidence-based treatment for this disorder is delivered efficiently and effectively. Family-based treatment (FBT) is the most efficacious treatment currently available for young people with AN (Le Grange et al., 2016; Lock & Le Grange, 2019). FBT is an outpatient behavioural treatment which emphasises the parents as the primary resource in the recovery of young people with AN (Anderson et al., 2017). However, there is a concerning inequity in access and treatment outcomes for people with AN, particularly among those in regional and rural populations. Telehealth offers a viable, scalable solution to this critical issue, and preliminary research in the USA demonstrated equivalent outcomes for FBT delivered via telehealth compared to face-to-face therapy (Anderson et al., 2017). The proposed study sets out to build on this vital research, testing the efficacy, feasibility, acceptability and cost-effectiveness of delivering FBT via telehealth to 30 young people and their families living in regional and rural New South Wales. This pioneering study brings together a multidisciplinary team of national and international experts to address both the treatment needs of regional and rural families; and the needs of regional and rural health services. Further, it will inform future efforts designed to improve the health of all Australians impacted by this debilitating disorder.

This study aims to find out if receiving intravenous iron ferric carboxymaltose (FCM) will reduce the incidence of anaemia while patients are receiving chemotherapy before or after surgery for breast cancer, and whether this is associated with an improvement in quality of life (QoL) and exercise tolerance. Who is it for? This study may be suitable if you are 18 years or older and will be starting adjuvant or neoadjuvant chemotherapy to treat early or locally advanced resected breast cancer. Trial Details Participants will be randomly allocated to receive either: 1) Iron ferric carboxymaltose (FCM) intravenously at baseline and further FCM if functional iron deficiency criteria are met OR 2) Standard of care during chemotherapy according to local guidelines. All participants will be regularly monitored every 5-6 weeks (depending on the type of chemotherapy) throughout treatment to evaluate their health. There will be a final treatment visit 3 weeks after the last dose of chemotherapy. Follow-up visits will occur at 3 months, 6 months and 12 months after the last dose of chemotherapy. Further treatment will be at the discretion of the participant and their treating clinician. At each visit, all participants will: * Complete online functional assessments to assess cognitive function, daily function and quality of life, using the PROMIS Cognitive Function Short Form 8a (PROMIS-Cog 8a), Daily Cognition and Mood (DCAM) cognitive assessment, and FACT-An * Complete a 6 Minute Walk Test to evaluate exercise tolerance * Have blood samples collected for additional assessments of iron parameters in the blood. It is hoped that this research will improve the quality of life of women undergoing adjuvant or neoadjuvant chemotherapy for breast cancer.

The purpose of this study is to assess the safety and tolerability of REVx-99, as well as the Pharmacokinetics (PK- how your body uses the study drug) and pharmacodynamics (PD - how the study drug carries out its actions on the body). We are doing this study in healthy men and women to find out: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will compare REVTx-99 with placebo. A placebo has no active drug in it. One group of participants will receive REVTx-99 and another group will receive the placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. We will be testing a single dose of the study drug in up to 40 healthy volunteers who will be divided into 5 cohorts of 8 people each and testing multiple doses in a single cohort of 8 people. Each single dose cohort is planned to receive an increasing dose of REVTx-99.