ANZCTR search results

The study is evaluating the feasibility of an E-Health eating and nutrition intervention (called ENeRgy-KIDS) for children after cancer treatment. Who is it for? Parents/carers and their children may be eligible to join this study if the child has been treated for childhood cancer at Sydney Children’s Hospital within the previous 5 years, and is aged 12 years or less. The child should also have been clinically identified as having a maladaptive feeding behaviour of 'fussy eating' post cancer treatment. Trial details All eligible parents/carers and their children will receive the ENeRgy-KIDS intervention. This is a parent and child targeted E-health diet and feeding behaviour program. The program consists of weekly, 90 minute E-Health treatment sessions, delivered over 6 weeks to provide diet education specific to the needs of childhood cancer patients after cancer treatment. The program will include information on how to manage child feeding behaviors, evidence-based best feeding practices by parents, healthy nutrition/diet after cancer treatment, medical long term effects of cancer treatment, healthy lifestyle now and in the future and goal setting. The program will also consist of a 15 minute child component that will deliver nutrition information and feeding therapy techniques through fun messy play and workbook activities. Children will undergo dietary assessment and body composition measurements at enrolment, at the end of the program, and 3 months later in order to assess the feasibility of the intervention. Parents will provide information on their child’s eating behaviours and diet at enrolment, at the end of the program, and 3 months later in order to assess the feasibility of the intervention. Parents will also provide information on how useful and easy to use the program was at the end of the program.

A limited amount is known about the key determinants of the health and social outcomes for people who have sustained an injury as a result of a land transport crash and, in particular, the extent to which determinants specifically related to the compensation process are relevant. The proposed investigation will seek to: 1) Identify individual and system factors influencing the health and social outcomes of people who have sustained an injury related to a land transport crash and who seek compensation through a compulsory third party (CTP) compensation scheme; 2) Identify individual and system factors influencing the health and social outcomes of people who have sustained a non­compensable injury in a land transport crash in NSW; 3) Identify the key factors that explain the differences between those who apply for compensation and those who are eligible to apply but do not. There are a number of domains, which relate to the individual and the system, which will be explored: ­ Characteristics related to the individual that influence the likelihood of applying for compensation ­ Characteristics related to the health service experience process ­ Characteristics related to the claims process ­ Characteristics related to the liability and fault process ­ Characteristics related to the legal representation process The study will utilise an inception cohort design, with a sample size of 1,500 participants aged 17 years or older, who are injured as a result of a crash involving a motorised vehicle in NSW and who have been diagnosed with an injury within 28 days of the crash. Recruitment will be through metropolitan and rural hospital emergency departments, general practitioners, physiotherapy clinics, police crash records and the Motor Accidents Authority claims database. People with severe injury, those unable to give consent due to cognitive impairment, those with minor localised soft tissue injury, those with a self harm related injury or those where a family member has died as a result of the crash, will be excluded. Data about health and social recovery outcomes and variables that potentially influence these outcomes will be collected by questionnaire administered by telephone or by written questionnaire for people who are deaf or prefer to complete a written questionnaire. There will be a focus on key variables identified in the literature that are associated with health outcomes. The questionnaire will be no longer than 45 minutes and be conducted at baseline (within 28 days of the motor vehicle crash), 6, 12 and 24 months post­injury. Detailed statistical analyses will explore the associations and interactions between the measured variables and health and social recovery outcomes.

The aim of this study is to assess whether exercise combined with advice is more effective than advice alone in reducing the incidence of lymphoedema following surgery for gynaecological cancer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to undergo inguinal or pelvic lymph node dissection for gynaecological cancer management at Monash Medical Centre, Moorabbin campus. Trial Details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undertake a lower limb exercise programme and receive advice about the prevention of lymphoedema. The exercise programme will be taught by a physiotherapist and then completed by the participant in their own home. The exercises will take 15 minutes to complete twice a day for a 3 month duration. A rubber exercise band will be required for some of the exercises and will be provided by the physiotherapist at no cost to the participant. Participants in the other group will receive advice only. this is provided by the physiotherapist in an education leaflet which details strategies for reducing the risk of triggering lymphoedema e.g. skin care, weight maintenance etc Participants will be assessed pre-operatively, at 1 month post-operatively, and then at 6 weeks after chemotherapy or radiotherapy or at 3 months if no adjuvant therapies are required. The assessments will involve measurements of lower limb volume and completion of a quality of life questionnaire

The main aim of this study is to investigate whether increasing the amount of physical activity results in better mobility outcomes in frail, older people. This study will be performed during hospital based rehabilitation and will be compared to mobility outcomes resulting from usual care. A second aim is to investigate whether this physical activity intervention results in improvements in quality of life. Finally we plan to investigate whether increasing the amount of physical activity during rehabilitation is cost effective. Participants will be recruited from two Victorian hospitals which offer inpatient rehabilitation to older adults. Older people receiving inpatient rehabilitation will be randomly assigned to an intervention group or a control group. The intervention group will receive extra physical activity on weekdays and weekends while the control group will receive additional social interaction. Both groups will be assessed at baseline, discharge from hospital and at 6 months. The primary outcome for this study is gait speed, as measured by the 6 metre walk test. Other outcomes relating to mobility, function and quality of life will also be assessed. At the end of the study a health economic analysis will be performed to assess whether the extra physical activity provided was cost effective, all factors considered.

A parallel group randomised control trial to evaluate the impact of viewing images of a future slimmer self on efforts to lose weight.

This randomised controlled trial aims to determine whether a tantalum trabecular metal acetabular component in a primary total hip replacement prosthesis can achieve adequate initial fixation without the use of screws. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure acetabular component migration in vivo.

Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy compared to traditional face-to-face cognitive behavioural therapy in a 3-group randomised controlled trial. The main aims are to: (a) evaluate the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to evaluate the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 210 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study or will complete pre-screening measures online. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. An alternative online pre-screening and consent process is also in place. A clinical assessment will then be completed by phone and participants will be asked to complete baseline, pre-treatment questionnaires by visiting the secure website. Women will then be randomised in a 1:1:1 ratio to Web-based or face-to-face CBT (n = 70 in each), or to treatment as usual (n = 70), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-treatment.

Heart failure (HF) is a common heart condition whereby the pumping capacity of the heart is significantly reduced. It is the end result of many conditions which weaken the heart muscle. Atrial fibrillation (AF) is a common electrical disturbance of the heart which results in rapid and irregular heart rates which may cause HF or significantly worsen pre-existing HF. Similarly, HF may cause AF which may then worsen the severity of HF. Catheter ablation of AF is a minimally invasive procedure (involving the use of specialized instruments through the groin to make a small burn in the area of the heart that is responsible for irregular heart rates) which can eliminate AF in many patients. However, in patients with AF and HF, it is currently difficult to identify those in whom the AF is causing or significantly contributing to the HF. Such patients may benefit from catheter ablation. Patients with HF display a unique pattern of scarring in the heart muscle capable of being detected by magnetic resonance imaging (MRI) (non-invasive scan of the heart). The amount of scarring in the heart muscle appears proportional to the degree of reversibility of HF. Thus in patients with AF and HF, we propose that MRI may help identify those patients whose HF is most likely to improve, or even completely reverse, following catheter ablation. In this way, catheter ablation may become a useful tool in the treatment of patients with AF and HF.

Each year over 100,000 people die of snake bite, some of whom are Australian. The current recommended first aid (applying a pressure bandage and immobilising the victim) can be very effective but this method of first aid is often not performed correctly. We are trying to identify simpler and more effective methods, and methods that might allow the victim to still walk to get help. The research will NOT use snakes or snakebites or snake venom! The aim is to measure how fast it takes for a simulated snake bite, “mock venom”, to reach the blood stream after an injection in the skin in the participants leg. comparisons will be made, on separate days, with different new methods of first aid (a pressure pad or a cold pack applied over the simulated bite site). A further aim will be to test to see if the pressure pad method still works when the participant walks slowly on a treadmill.

The primary purpose of this study is to evaluate tissue expander fill and final volumes in women undergoing breast reconstruction. Who is it for? This study included women who underwent tissue expander/implant based breast reconstruction following mastectomy. The surgeries were conducted over a 6 month period in 2012. Trial details All participants in this study underwent breast reconstruction surgery with tissue expander. The tissue expander fill volume inserted at the time of first implant was compared to the final volume on removal of the tissue expander at the time of second stage reconstructions (about 3-4 months later). A discrepancy between these values affects the size of the second stage implant and thus the cosmetic outcome.