ANZCTR search results

We will conduct a 2-year randomised controlled trial to investigate the efficacy and safety of progressive resistance strength training of the foot and ankle in 60 children with Charcot-Marie-Tooth disease (CMT). We will test the hypothesis that progressive resistance strength training is a safe intervention that will improve strength, disability, gait and quality of life in children affected by CMT.

The study is evaluating the feasibility of accelerated partial breast irradiation (APBI) in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman above 50 years of age who has been diagnosed with early or local breast cancer. Trial details: All participants in this study will undergo a procedure called accelerated partial breast irradiation (APBI). This involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely loads a high dose rate radioactive source into the catheters and determines the amount of time that the source remains in each specific dwell position. In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures such as the lungs, heart and contralateral breast. Treatment is delivered twice daily over 5 days in total with the catheters. Each treatment will take 10-15 minutes with an inter-fraction interval of at least 6 hours. Participants will be assessed post treatment, and at 6 weeks, 6 months, 1 year, and annually thereafter for up to 10 years in order to evaluate the safety of the procedure and effect on cosmetic outcomes, quality of life and cancer recurrence.

This study examines the efficacy of a school-based resilience program for adolescents. The program is based on Positive Psychology and Acceptance and Commitment Therapy and runs for 1 hour per week for eight weeks. It is hypothesised that the program will prevent future cases of mental health problems, reduce psychopathology that exists at the time of the program, and increase subjective wellbeing.

Multicentre randomised double-blinded sham-lesion control trial to evaluate the role and effectiveness of pulsed radiofrequency treatment (PRF) of a peripheral nociceptive trigger (i.e. neuroma) in the management of phantom and residual limb pain. Participants will be recruited through the Victorian Artificial Limb Program Outpatient Clinic at Royal Park Campus RMH. Eligible patients will undergo perineuromal injections with local anaesthetic performed under ultrasound. Responses will be recorded as positive if the participant experiences a decrease in pain intensity of at least 50%. Patients with a positive response will proceed to PRF or placebo assigned in a random manner. Participants will be followed up at 1 week, 4 weeks and 3 months. Measures of pain intensity (BPI), pain quality (SF MacGill Pain Questionaire), physical functioning (BPI), emotional functioning (DASS), patients global rating of improvement and satisfaction (PGIC), health-related quality of life, prosthetic use (TAPES-R), healthcare utilisation will be obtained at each review.

Weight loss following gastric band surgery, defined as % excess weight loss (poor - <20%, moderate 20-45% or good >45%), will be correlated to rates of progression from impaired fasting glucose to diabetes. These rates will be compared to those of AusDiab participants from a similar time period.

Participants will be randomised to one of the two conditions and prescribed the same diet which they will be asked to follow for a 24-week period. The primary purpose of this study is to evaluate the effectiveness of different mobile phone applications designed to support people to lose weight by undertaking a Meal Replacement Program over a 24-week period

We will test a new approach to a form of heart failure (HF) with no current treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These “stiff” hearts pump strongly but fill inefficiently resulting in poor exercise capacity and high death rates. Treatments that help when heart pumping action is poor are of no benefit in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the kidneys (“renal denervation”; RDN) has been able to reduce BP in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in HF. We will compare effects of RDN and standard medical treatment on heart function, exercise capacity and quality of life in 144 patients with HFPEF.

Clinical study aiming to assess how the pharmacokinetics (i.e. the way the body absorbs, distributes and gets rid of a drug), safety, and tolerability of the drug siponimod are influenced by the presence of specific genetic characteristics (namely CYP2C9 genotypes).

The adoption of healthy school canteen policies has been recommended as a strategy to prevent excessive weight gain. A number of jurisdictions in Australia and internationally have policies requiring school adoption of healthy canteen strategies. Despite this, many schools have not adopted healthy canteen practices consistent with mandated policies. One reason why many schools are yet to adopt healthy canteen policy is that current interventions aiming to improve practice cannot feasibility be extended to large numbers of schools, in particular to those in rural and remote communities. A promising solution to support population wide practice change of school canteens is audit and feedback. However, currently no evaluation of audit and feedback has been conducted in this setting. The aim of this research is to assess the effectiveness of an audit and feedback intervention to increase the adoption of canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). Seventy-two primary schools that provide canteen services to students will be recruited to participate. Schools will be randomised to an intervention group receiving a 12 month audit and feedback intervention delivered via telephone and written report, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dieticians in: i) the proportion of schools with a canteen menu containing foods or beverages restricted (‘red’ items) under the policy and; ii) the proportion of schools where healthy canteen items (‘green’) represent the majority (>50%) of products listed on the menu as recommended by the policy. The proposed research is the first evaluation of an audit and feedback intervention in primary schools. The study is of relevance to the efficient delivery of population wide services, particularly to those in rural and remote communities, aiming to reduce the burden of obesity.

The study is evaluating the effectiveness of structured interventions to improve quality of life in head and neck cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a diagnosis of head and neck cancer for which you have completed treatment within the past month at one of the participating sites. Trial details: Participants in this trial are randomly (by chance) allocated to one of three groups. Participants in group 1 will receive a written resource, “Facing the future: Living with confidence after treatment for head and neck cancer” in addition to usual care. The 61 page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as diet and swallowing problems, oral health, fatigue, pain, stress, emotional concerns and communication. Participants in Group 2 will continue to receive usual care and the resource “Facing the future: Living with confidence after treatment for head and neck cancer”. In addition they will meet with an oncology nurse who has undergone specific training in developing a tailored survivorship care plan. The face-to-face meeting will take between 30 and 60 minutes and will focus on issues which are of concern to the patient. For example the care plan might include a graded approach to improving fatigue, or a plan about how to get into a routine to manage oral health. It might include details about how to cope with social interactions and relationship concerns, or fear of eating in public. The care plan will be designed to not just list information – it will be designed to enable participants to work out how to feel more in control of their health, deal with anxiety and give them confidence about when and how to get professional advice as needed. Once the survivorship care plan is complete the patient will receive a written copy so that they can keep working on the issues in it. A copy will also be sent to their General Practitioner so that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. Participants in Group 3 will continue to receive only the standard care provided at the clinic where they received treatment. Participants will be asked to complete some questionnaires at the start of the study, and 3 and 6 months later in order to assess their quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.