ANZCTR search results

Cardiac rehabilitation (CR) is an important secondary prevention strategy, yet women’s participation is low. It has been postulated that lower self-efficacy and social and psychological factors contribute to a low participation (Briffa et al 2009). Literature suggests that CR programs specifically designed for women, based on their expressed needs, are effective in improving the physical functioning and symptom status of participants. The aim of this project is to investigate the use of a gendered approach to healthcare through developing strategies to improve women’s heart health in Australia, including evaluating in a randomised controlled trial the benefit of a group-based program, tailored specifically to the needs of women, to increased self-efficacy and improve functional status. Key components of the intervention include information about heart disease, changing social roles, the impact of emotions on cardiovascular health, coping with stress, communication, and strategies to promote self-management. This project incorporates a gendered approach to health care, which is commonly lacking in cardiovascular science.

Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. The societal costs are significant with an estimated $10.9 billion in direct and indirect costs in Australia. Insomnia patients have poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The majority of people with insomnia who are treated by primary care physicians will be prescribed hypnotic medications. This is despite substantial evidence that hypnotics are only marginally more effective than placebo and are not effective for long-term management. Hypnotics also come with significant risk for a range of side-effects (falls, car crashes, accidents and potentially increased overall mortality). Cognitive Behaviour Therapy for Insomnia (CBTi) has shown to be more effective long-term solution for people with insomnia. However, CBTi has major drawbacks as it requires specifically trained therapists, and is a complex time-consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a behavioural component of CBTi that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times so that individuals are mildly sleep restricted which promotes sleep onset and decreases wake time in bed. The clinical delivery of the therapy can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but requires clinician input regularly. Sleep Consolidation Therapy has the potential to be delivered more widely as it has been shown to be feasible in primary care settings. We have recently developed a proof-of-concept mobile application following participatory design, user experience focus groups and a pilot study testing the engagement of the application. The mobile application can deliver population-based therapy for insomnia patients thereby improving scalability and treatment options. We now want to test the effectiveness of the mobile application to deliver Sleep Consolidation Therapy in participants with insomnia symptoms.

This study will evaluate the safety and efficacy of External Beam Radiation Therapy (EBRT) in combination with 177 Lu-prostate-specific membrane antigen (Lu-PSMA) theranostic against EBRT alone in patients with recurrent prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged 45 years or above and have a confirmed diagnosis of recurrent prostate cancer following previous radical prostatectomy (RP) with curative intent. Study details Participants will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo external beam radiation therapy (EBRT) in combination with 177Lu-PSMA theranostic treatment. EBRT will be administered daily (on weekdays) over 6.5-7 weeks. 177Lu-PSMA will be administered intravenously in three treatment cycles of once every 8 weeks. Participants in the other group will receive EBRT alone. All participants will be asked to attend 3-monthly follow up visits from the end of treatment for a total period of 24 months, in order to assess treatment response, safety, and health-related quality of life. It is hoped that EBRT delivered together with 177Lu-PSMA will enable the delivery of higher radiation doses to the tumour, resulting in a greater treatment response and improved survival.

This project aims to establish a shared registry between Australia and New Zealand in which all patient outcomes and patterns of care are measured for anyone undergoing Nephrectomy surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo nephrectomy or nephroureterectomy surgery in Australia or New Zealand. Study details All participants in this study will have the details of their nephrectomy or nephroureterectomy surgery recorded in a Registry, including diagnosis by procedure type, technique by procedure type (e.g. laparoscopic/ robotic/ open), average patient risk factors, complication rate (risk adjusted), transfusion rate (risk adjusted), mortality rate, and length of stay. By collecting this information we hope to identify trends and improve the quality of patient care as well as guide future surgical training.

The purpose of this study is to determine whether omega-3 supplementation attenuates aggressive behaviours in adult male prisoners who have previously demonstrated aggression within the prison. Prisoners will be randomly assigned to an active or placebo supplementation condition. Measures of institutional aggression and hypothesised associated mental health condition (ADHD) will be collected to assess the impact of omega-3 supplementation. It is hypothesised that prisoners receiving the active (omega-3) supplements will demonstrate reduced aggressive behaviour and reduced ADHD symptoms, compared to prisoners receiving a placebo supplement.

Background summary: Refugees experience a higher incidence of posttraumatic stress disorder (PTSD) and increased levels of chronicity. Effective treatment is a challenge worldwide and is likely to require a multifaceted approach. Neurofeedback (EEG biofeedback) is utilized to enable individuals to modulate and retrain brain electrical activity through training new pathways of activation that can increase the brain’s capacity to self-regulate. STARTTS’ neurofeedback program was developed to complement counselling for refugee related PTSD and has had good clinical success. However, evidence from a randomized controlled trial is needed. Objectives: The primary aim of this project is to examine the efficacy of neurofeedback training for alleviating chronic posttraumatic stress symptoms in adult refugees. We hypothesize a reduction in symptoms, accompanied by changes in functional brain activity reflecting improved cognitive control and emotion regulation. Study Plan: Willing and eligible, existing STARTTS clients will be randomized to participate in neurofeedback integrated with counselling (NFT) or to an active control “lifestyle enhancement intervention” (LEI) involving sessions focusing on nutrition and physical activity in addition to counselling. Both interventions will involve 30 bi-weekly sessions over 15 weeks. A total of eighty participants will be enrolled over two years and will complete questionnaire and EEG assessments pre- and post-intervention and at 3-month follow-up.

The purpose of this study is to see if a 5 session psychological therapy program delivered after bone marrow transplantation can have a positive impact on quality of life and psychological distress in these patients. Who is it for? You may be eligible for this study if you are aged 18 or older and have received a bone marrow transplant in the last 3 to 12 months. Study details All participants in this study will receive 5 individual sessions of face-to-face cognitive behavioural therapy targeting mental adjustment and coping strategies. Participants will also need to do approximately 10 minutes of ‘homework’ every day following each of the first 4 sessions. As part of the study, participants will complete questionnaires about their quality of life, psychological distress, mental adjustment, coping and self-efficacy before and after the 5 session intervention. Participants will also be asked to complete questionnaires about their psychological distress and homework completion at each session. It is hoped this research will provide evidence this program improves mental health outcomes in this patient population.

The qNox monitoring System (Conox Monitor; Fresenius Kabi) is an electroencephalogram-based (sticky electrode on forehead) dimensionless score (0-100) which claims to reflect levels of analgesia in anaesthetized patients. Higher levels of the score may reflect higher levels of noxious stimulation, or a higher likelihood of a patient to respond to noxious stimuli. Aim of the current study is to investigate whether a higher qNox score during, and at the end of surgery may be associated with a higher likelihood of significant postoperative pain. 150 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia and state entropy depth of anaesthesia monitoring will be included. In addition to standard monitoring, a row of sticky electrodes (similar to the ones used for monitoring the long-established state entropy monitor) will be placed on the patients’ forehead. No other intervention is done for the trial. QNox will be monitored specifically at the end of surgery before patient arousal. Once awake in recovery, patients’ pain will be rated on a numeric rating scale (0-10) every 5 minutes (as per recovery room routine). The first 4 pain ratings will be used to analyse any relationship between qNox and postoperative pain. No other study-related intervention will take place. Participating patients will neither be inconvenienced nor harmed in any way by inclusion in this trial.

Perioperative lignocaine infusions have significant benefits for patients undergoing major abdominal surgery in regards to analgesia, reduced opioid requirements, earlier return of normal bowel function and potentially even enhanced recovery and discharge after surgery. Currently there is significant heterogeneity in the various suggested lignocaine dosing regimens and a real paucity of evidence in regards to optimal dosing in the bariatric population. As a result, despite the benefits of perioperative lignocaine infusions particularly in the bariatric population, clinicians cannot be confident about the efficacy and safety of currently suggested lignocaine infusion regimes in this population group. As a result our objective is to develop a pharmacokinetic model of lignocaine infusion including patients at the extremes of BMI and thus develop a regimen for bariatric patients that achieves safe but effective therapeutic dosing.

The purpose of this study is to compare a new product (called Herceptin biosimilar) to two existing Herceptin products. Who is it for? You may be eligible for this study if you are a healthy male aged between 18 and 45 years old. Study details Participants in this study will be randomised (by chance) into three groups. All participants will have a single infusion of either the new product or one of the two existing products. The infusion will be delivered through a needle in the arm over 90 minutes or less. After the infusion, participants will provide a number of blood samples so the products can be compared. It is hoped this research will be used to improve health outcomes, by providing lower priced treatments to larger numbers of cancer patients.