ANZCTR search results

Stress in the workplace is prevalent, with Australians reporting significantly lower overall workplace wellbeing in 2013 compared to previous years. Psychological injury is now the second most common cause of workplace compensation claims in Australia, and the direct cost to employers is estimated to be greater than $10 billion annual in terms of lost productivity. Thus, from an individual and public health perspective, there is an imperative to implement low risk, economically viable and effective programs to reduce workplace-stress and improve employee outcomes such as productivity, satisfaction and engagement. Mindfulness-based programs have become increasingly popular as a means of targeting enhanced wellness at work as well as combatting negative consequences of excessive workplace stress. Mindfulness involves making a commitment to being fully conscious in the present moment without judgement, in an attitude of openness and acceptance. To date, reviews report a small to moderate effect for mindfulness in reducing multiple negative dimensions of psychological distress including anxiety, depression and appraised stress, although this is not specific for the workplace setting. Further research into the benefit of mindfulness programs in reducing workplace stress and quality of productivity is warranted. This study aims to assess the effectiveness of structured, mindfulness-based program on decreasing work related stress and enhancing workplace wellbeing and engagement in fulltime university employees. Based on current available evidence, we hypothesise that mindfulness-based program participation will: 1. Improve employee work-related outcomes including workplace wellbeing and engagement 2. Reduce employee levels of stress, anxiety and improve mood

The primary purpose of this study is to systematically explore factors behind the low and uneven rates of breast reconstruction across Australia, It aims to identify practical ways to improve equity of access for women regardless of where they live, their age and ethnic/cultural backgrounds. It will produce acceptable, feasible and readily-translatable recommendations for practice and policy changes to address disparities in women’s breast reconstruction options. Who is it for? You may be eligible to participate in this study if you are a woman who has had mastectomy for breast cancer, a breast care nurse, a breast or plastic surgeon or a clinical or policy person involved in making decisions about breast reconstruction. Study details: The study will primarily involve one-off interviews, either face-to-face or by telephone, with eligible participants. It is hoped that the findings of this study will provide recommendations for practice and policy changes which improve the equity of access to breast reconstruction in Australia.

The primary purpose of this study is to evaluate the efficacy of bright light therapy for improving sleep and quality of life in children undergoing treatment for acute lymphoblastic leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 3 to 9 years of age, and undergoing maintenance treatment for acute lymphoblastic leukaemia. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either bright light therapy or standard leukaemia care with no bright light therapy. Participants allocated to the bright light therapy group will be asked to wear a bright light visor for 30 minutes immediately after waking up each morning for the 84 days of the second maintenance treatment cycle. To assess sleep, fatigue, mood, and quality of life measures, researchers will use a combination of home-based assessment of sleep (actigraphy), a detailed sleep diary and questionnaires. The questionnaires will be completed by both the child and the parents at the beginning and the end of the light therapy, and six months after therapy, and will take approximately 30 minutes to complete at each time point. It is hoped that bright light therapy will provide a cost-effective method of improving sleep and quality of life for children undergoing treatment for acute lymphoblastic leukaemia who are a group at risk of development of potentially long-term sleep problems, increased psychological distress, poor treatment resilience and low quality of life.

The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence. Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed. At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history. The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.

There is evidence for a link between hypertension and gut dysbiosis, microbiotical profile and inflammation, and inflammation and cognition. We postulate Kyolic aged garlic extract to influence gut microbiota, and to restore gut dysbiosis in hypertensives. Our study will comprise a double-blind parallel randomised placebo-controlled trial of 3 months duration investigating the effect of Kyolic aged garlic extract on gut microbiota, inflammatory markers, and cognitive function in patients with high blood pressure.

The purpose of this study is to assess understanding of a clinical pathway for anxiety and depression screening and treatment in cancer patient. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of cancer. Study details Participants in this study will all receive website content (in a printed format) and a pamphlet which contain information about a clinical pathway for screening and treatment of anxiety and depression in cancer patients. Clinical pathways provide evidence-based recommendations to guide best practice and consistent care for specific patient concerns. This clinical pathway provides a pathway for screening, assessment, referral and treatment of anxiety and depression in cancer care. It was developed by a working group led by PoCoG at the University of Sydney. Focus groups and/or semi-structured interviews will then be conducted 2 weeks after participants receive the review materials. The focus groups and semi-structured interviews will collect feedback and assess participant’s understanding of clinical pathways. In this study, we will collect feedback so that we can improve the website content and pamphlet as well as determining patient understanding of a clinical pathway.

The purpose of this study is to investigate whether the Latarjet surgical procedure causes any detectable change in the strength of the biceps muscle post-operatively. If you agree to participate in the study, an appointment will be arranged for you to attend for a preoperative biceps strength test (about 15mins duration) at the University of Western Australia. This will involve taking measurements from a resistance machine similar to gym equipment which records your strength. We will also give you a short questionnaire on your shoulder function for you to complete which will take about 10-15 minutes. Your surgery and rehabilitation will not be affected. After 12 months have passed we will contact you by telephone to arrange a time for you to come in and repeat the strength test and questionnaire to see whether your biceps strength and shoulder function have changed.

We aim to investigate the impact of a telephone-based education schemes for newly diagnosed patients with glaucoma. Newly diagnosed glaucoma patients treated with drops are randomised to either the control or treatment arm. All have questionnaires administered over the telephone at the study outset and at completion, 4 weeks following the outset. The questionnaires include a Glaucoma-knowledge Questionnaire, an anxiety scale and an Eye Drop Satisfaction Questionnaire. Patients in the intervention arm will receive the education in the first week of the study period. THose in the control arm will only receive that information once the study is completed. We will measure differences in changes of scores from outset to conclusion of the study looking for differences between the intervention and control groups.

Aim? To examine whether a targeted and supervised exercise program can suppress tumour formation, growth and activity in advanced prostate cancer patients with bone metastases in Humans and examine the feasibility, safety and efficacy of combining spinal isometric training with a modular multi-modal program M3EP program. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more and have histologically confirmed adenocarcinoma of the prostate with one or more metastatic lesions in the thoracic or lumbar spine. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a 12 week exercise intervention. The exercise intervention group will receive a 3-month, supervised and individually tailored modular multi-modal exercise program (M3EP) with spinal isometric training (SIT). M3EP component of the program will be comprised of resistance, aerobic and flexibility exercises undertaken 3 times per week in an exercise clinic setting, supervised by an accredited exercise physiologist. The SIT component of the program will comprise of exercises that isometrically load deep spinal muscles. These will be performed 5 times per week (3 in clinic and 2 at home). Participants in the other group will receive usual care for the duration of the trial. Following the trial, the control group will be offered the same exercise program if the intervention is deemed to be feasible and efficacious. All participants will complete assessments at baseline and after 12 weeks in order to evaluate tumour formation and growth, muscle-bone health, adiposity, physical fitness, functional capacity, and psychosocial health.

This study will provide valuable data on the safe and efficacious use of muscle stimulation therapies currently applied by physiotherapists to patients receiving lifesaving Extra Corporeal Membrane Oxygenation (ECMO) which provides external cardiac and respiratory support for patients. Patients receiving ECMO are critically unwell and their prolonged ICU stays are associated with major loss of muscle mass and strength, and also with impaired physical function. Previously published experience from The Prince Charles Hospital (TPCH) suggests that this same patient group maybe at increased risk of foot necrosis (tissue death) either as a result of their disease process or machine techniques from the ECMO. Muscle stimulation is currently utilised by physiotherapists in TPCH ICU in an attempt to preserve the muscle mass of critically ill immobilised patients. Its effects in patients receiving ECMO have not been investigated. Changes in regional blood flow are also associated with the application of muscle stimulation.This study will demonstrate if a beneficial improvement in foot blood flow occurs as a result of muscle stimulation application which may prevent the development of foot problems in patients undergoing rescue therapy via ECMO. It will also be used to guide future research studies, and potentially therapy at this and other centres.