ANZCTR search results

The aim of this study is to explore physiological and psychosocial differences between women classified as overweight/obese with premenopausal breast cancer, and postmenopausal breast cancer, and compare their response to a partial meal replacement dietary intervention. Who is it for? You may be eligible to participate in this study if you are: • A female who was premenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation); or • A female who was postmenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation). Study details All participants in this study will undergo a dietary intervention. This will consist of a partial meal replacement diet in conjunction with face-to-face sessions, telephone calls and a meal replacement booklet to support women to lose weight and increase exercise. All women will receive a 12-week dietary program with regular sessions with an Accredited Practising Dietitian. Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 11 weeks followed by 1-2 shakes per day for the remaining week (based on the individual’s requirements and preferences). On the partial meal replacement diet, participants will be advised to eat a main meal (lunch or dinner) consisting of 2 cups of non-starchy vegetables, lean protein (serving based on protein requirements of 1-1.2g/kg body weight) and 1 teaspoon of olive oil. Data will be collected at baseline and 12 weeks (end-of-intervention). All participants will be undergo assessments at enrolment, 6 weeks and 12 weeks (end-of-intervention) in order to evaluate any changes in body mass, body composition, dietary intake, physical activity, quality of life and psychological well-being. It is hoped that this study will enable us to determine whether a larger trial would be feasible.

The proposed research project will focus intervening in the prison-to-community transition period to improve post-release mental health and other outcomes. Our research will specifically test whether an early and individualised critical-time intervention for prisoners released into the community is feasible locally and whether it can, firstly, increase contact with community mental health services and, secondly, whether there is any consequent benefit for mental health status, functioning or reoffending. It will utilise a randomised controlled trial (RCT) design, with longitudinal multi-source follow-up to assess the feasibility and efficacy of a novel ‘critical-time’ intervention. The intervention is to be implemented during the prison-to-community transition period. As part of the intervention, the research team will identify prisoners entering custody who have severe mental illness, have committed relatively minor offences, and are likely to benefit from ongoing community mental health team input on release. The research team will identify the appropriate CMHT for the participant early in their custodial episode and make contact with the key worker. In collaboration with custodial mental health clinicians involved in treating the prisoner, we will develop an individualised care plan for each participant which will be forwarded to the Community Mental Health Team (CMHT) as part of the project. We will follow-up with the key worker and the participant to encourage ongoing community mental health engagement following the participant’s release from custody.

Postprandial hypotension (PPH) is defined as a larger than expected fall in blood pressure following a meal – the more exact definition is a fall in blood pressure of greater than 20mmHg for a period lasting longer than 30 minutes, following a meal. PPH may lead to fainting and is common in older people. In this study, we are interested in seeing whether a preload containing whey protein and guar (Omniblend) can reduce the fall in blood pressure after a sugary drink – and also whether the rate of stomach emptying is affected by this preload.

The study will evaluate the effect of the study drug, AB-506, on the single dose pharmacokinetics of an oral contraceptive in healthy female participants. The duration of the study will be approximately 7 weeks, including the screening period.

This research aims to evaluate the effect of the Fearless Me! program on anxiety for children and adolescents with intellectual disabilities. The Fearless Me! program is a Cognitive Behaviour Therapy treatment which has been specifically adapted for the needs of children with mild and moderate intellectual disabilities. The Fearless Me! program is a weekly, ten session therapy program that aims to teach children and adolescents skills to manage and reduce their anxiety, and involves face to face therapy sessions, as well as an online website to practice skills. It is hypothesised that the program will reduce anxiety for those with clinical or subclinical levels of anxiety, and improve overall quality of life.

Hysterectomy (removal of the womb) may be performed to try and improve quality of life for women experiencing benign (non-cancerous) conditions that can cause pelvic pain, heavy bleeding and prolapse. As it is an irreversible surgery after which the woman can no longer carry a pregnancy the decision to undergo hysterectomy may be difficult for both patients and their clinicians. We are interested in how and why women make the decision to undergo hysterectomy, how it changes their quality of life and experience of symptoms, if at all, and whether it is associated with significant relief or regret. We especially want to know if age and number of children a women has had at the time of hysterectomy influence their feelings of relief and/or regret. This information will help guide women and their clinicians considering hysterectomy as an option. We will contact women who have had a hysterectomy for benign conditions and ask them to complete a questionnaire to explore their feelings or relief and regret, and also get information about their medical history, decision making about hysterectomy, symptoms and quality of life after hysterectomy as well as current levels of stress and personality type. This information will be used to examine the relationship age and parity (number of children had) have with regret and relief after hysterectomy as well as look at other factors that influence this.

The proposed study aims to evaluate the efficacy of a stress-reduction intervention for unhealthy and disordered eating behaviours. The study will be conducted as a randomised control trial, with a wait-list control group and two intervention groups; one intervention group will be prompted to use the intervention, whilst the other will not. All groups will complete a baseline survey, followed by four weeks of ecological momentary assessment to obtain data regarding their eating behaviours and affect. During this time, the intervention groups will also be provided with brief stress-reduction activities via smartphone application that they can complete when stressed. Participants in the intervention groups will also complete a four-week follow-up survey. The study will recruit at least 183 women, aged 18 years and over, who report stress-related unhealthy or disordered eating. It is expected that use of the intervention will reduce the momentary and longer-term risk of disordered eating.

The Health4Life intervention uses web- and app-based technology to improve the physical and mental health of Australian teenagers. Unhealthy behaviours, such as eating poorly, smoking, risky alcohol use and physical inactivity, are known risk factors for serious chronic disease, the leading cause of death worldwide. Previous research has shown that these risk behaviours are well established by late adolescence and commonly co-occur as clusters. It has also been shown that these ‘risk clusters’ are associated with more immediate harms among young Australians, including anxiety, depression and psychological distress. To address these problems, we developed the Health4Life intervention. The Health4Life study utilises online technology and interactive cartoons to encourage young people to adopt six key health behaviours (“the Big 6”): healthy eating, healthy sleep, physical activity, limiting sedentary recreational screen time and being alcohol and smoke-free. By increasing knowledge and improving skills, this program aims to prevent or improve these behaviours before they become entrenched. The Health4Life program will recruit 7200 Year 7 students from 72 schools across Australia in 2019. It is anticipated that this intervention will improve both physical and mental health during adolescence, whilst also halting a potential trajectory towards chronic disease later in life. In addition, the Health4Life Biomarker Checkpoint will re-recruit a subsample of Health4Life participants (approx. 200) when they are in year 10, to assess any differences in anthropometric measurements, in depth dietary intake, C-reactive protein, and other heart-health biomarkers between intervention groups as part of a related sub-study for a PhD project.

Nerve conduction studies is the study of motor and sensory nerve function by measuring electrical parameters, e.g. velocity and amplitude, of peripherally (e.g. arm or leg) stimulated nerves. Stimulation and recording is typically performed by surface electrodes (metal conductors applied to the skin). Abnormalities on nerve conduction studies can usually be detected in established neuropathy but in early neuropathy nerve conduction studies may remain normal. F-waves are electrical responses stimulated and recorded at the periphery (e.g. hand or feet) that travel from the periphery (e.g. hand or feet) to the spinal cord and back similar to a rebound or boomerang. F-waves are more sensitive at detecting changes consistent with early diabetic neuropathy when examination of other nerves is normal. Preliminary evidence has shown that the study of F-waves using a fine needle in a muscle, so-called ‘single fibre F-waves’, is more precise and sensitive than surface electrodes in detecting early neuropathy in patients with diabetes. The purpose of this trial is to ascertain the utility of single fibre F-waves in comparison to nerve excitability testing and routine nerve conduction studies in patients with neuropathy or risk factors for neuropathy (i.e. diabetes/impaired glucose tolerance).

Chronic pain (3 months) occurs in up to two-thirds of patients after open-cardiac surgery. This is predominantly neuropathic pain; a consequence of nerve damage during instrumentation. Previous studies have shown pregabalin effectively reduces acute pain after cardiac surgery. There is, however, a lack of research regarding chronic pain. The PRACS (pregabalin for the prevention of chronic pain after open-cardiac surgery) trial aims to reduce chronic pain and improve quality of life for cardiac patients. This randomised, double-blind, placebo-controlled trial is a collaboration between anaesthetics, ICU and cardiothoracic surgery at Monash Medical Centre. We aim commence the trial in early 2019 with a target sample of 200 patients. The intervention group will receive active pregabalin (150mg before surgery and 75mg 12-hourly for 48 hours after surgery) while the control group will receive matching placebo. Participants will be monitored in hospital and at the 3 and 6 month mark