ANZCTR search results

Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is an approved treatment option for patients with depression in the Canada and several EU nations, with significant evidence demonstrating greater clinical outcomes following longer treatment courses. For patients with fibromyalgia, studies suggest rTMS may also offer a novel treatment approach for pain relief. However these effects are short-lasting thereby limiting its clinical application. Yet no studies to date have explored the effects of a treatment course of similar duration to that used in depression. In addition, there is a dearth of literature exploring target sites other than the motor cortex, such as the dorsolateral prefrontal cortex (DLPFC); a brain region directly implicated in the control of pain perception. In the proposed world-first study, we will carry-out a randomised double-blind placebo-controlled trial to assess the use of an rTMS treatment course applied to the DLPFC in patients who suffer from fibromyalgia. To do so, we will recruit a total of 40 patients with a diagnosis of fibromyalgia who will undergo a blind 4-week acute rTMS daily treatment course. We expect our proposed treatment course of rTMS to the DLPFC in patients with fibromyalgia will provide a model for an interventional treatment course that may be extended to other pain syndromes. Thereby reducing dependence on pharmaceutical treatments in patients who suffer from chronic pain and increasing quality of life for the millions of chronic pain sufferer's worldwide.

This study will develop and evaluate an online communication skills training program and compare it in terms of efficacy to an online + workshop training program for oncology health professionals working with cultural and linguistically diverse patients. Who is it for? You may be eligible to join this study if you are a health professional aged 18 years or more, who has worked for at least two consecutive years in an oncology setting in the fields of medical oncology, radiation oncology or as an oncology nurse. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in both groups will undertake an online communication skills training intervention. This involves undertaking a self-paced, interactive online module (approximately 2 hours in duration), to be completed within two weeks of completing the baseline questionnaire. Participants in group 2 will also attend a 1 1/2 hour workshop within 12 weeks of completion of the online intervention that will develop communication skills through role-played scenarios. Participants will be assessed on completion of the intervention to evaluate their competence in communicating with cultural and linguistically diverse patients, and satisfaction with the program.

Sciatica or sciatic neuralgia, a common form of lumbosacral radiculopathy, is characterized by low back pain that radiates to the leg below the knee and can be accompanied by sensory loss, motor weakness and reflex abnormalities. Sciatica is considered to be a prognostic indicator of poor outcome among patients with low back pain with a substantial proportion continuing to have persistent pain for two years or longer. The annual prevalence of sciatica is estimated to be between 14% and 2%. While guidelines provide clear and generally consistent recommendations for the prescription of drugs for non-specific low back pain this is not the case for sciatica. Patients with a clinical diagnosis of sciatica are about five times more likely to take drugs than those with low back pain only, with analgesic and adjuvant pain drugs being the mainstay of current treatment. The efficacy of these prescribed medications is varied and conflicting in this population. Gabapentin and Pregabalin represent a newer approach to the treatment of sciatica. Both are analgesics of GABA that modulate the calcium-channel subunits, possibly decreasing the neurotransmitter release associated with the central sensitization that occurs in sciatica. With the recent PBS listing of Pregabalin for neuropathic pain refractory to treatment with other drugs, we hypothesize pregabalin to be superior to gabapentin in reduction of pain for patients suffering sciatica. This head to head clinical trial will examine the effects of both agents in treating pain associated with sciatica compared to placebo in a randomised controlled setting.

There are no current Australian guidelines to promote screening for families experiencing premature ischaemic heart disease (PIHD), which would suggest that in Australia this is not being undertaken systematically. Without recommendations for family screening, an opportunity for targeted IHD prevention in the community is being overlooked. Targeting of primary prevention at families with a positive history could be a highly cost-effective strategy to tackle the burden of IHD in Australia. Evidence for the potential benefits and feasibility of this strategy is required to inform the development of guidelines/recommendations appropriate to the Australian population and health system. The objective of this project is to trial a primary prevention strategy targeted to families experiencing PIHD. Evidence that attendance to a general practitioner for cardiovascular risk factor assessment results in a reduction in absolute cardiovascular risk (ACR) in these first degree relatives is lacking. However we believe that advising high risk groups within the population about their risk factors is a necessary first step toward reduction of risk in these groups. Aim: This study will trial an intervention (including written and verbal advice) to prompt first degree relatives of patients with premature ischemic heart disease (PIHD) to attend their GP for a cardiovascular risk assessment, as the first step toward reduction of their absolute cardiovascular risk (ACR). Research Question: Does the provision of written and verbal advice, promoting cardiovascular risk assessment, to first-degree relatives of patients with PIHD, increase the proportion of relatives undertaking cardiovascular risk assessment in general practice? Hypothesis: Provision of written and verbal advice promoting cardiovascular risk assessment, to first-degree relatives of patients with PIHD, will result in an increase in the level of cardiovascular risk assessment undertaken from 25% to 50%.

This study will evaluate the effect of a drug called BBI608, a cancer stem cell inhibitor, for treatment of advanced colorectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced colorectal cancer for which no further standard anticancer therapy is appropriate or available. Trial Details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take BBI608 (Group 1) or a placebo (sham) (Group 2) tablets twice per day in continuous 28 day cycles. Treatment will continue for as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and are, in the opinion of the investigator, continuing to benefit from therapy. Participants will not know whether they are taking BBI608 or the placebo until after the trial is completed. Participants will be followed up every 4 weeks in order to evaluate how they are responding to treatment.

This study is evaluating the effect of fatigue management education on chemotherapy and radiotherapy patients' performance of daily living. Who is it for? You may be eligible to join this study if you are aged over 18 years and are scheduled to undergo outpatient chemotherapy and/or radiotherapy treatment for 20 or more days. Trial details: Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will attend a one hour group education session on how to manage fatigue caused by cancer treatment. It is delivered using a PowerPoint presentation and participants will be given a handbook, a goal setting sheet and a progress diary. The group session will be conducted before participants commence the course of treatment (chemotherapy and/or radiotherapy). Two follow-up phone calls using a structured script will be provided 2 and 4 weeks after each session to reinforce information given in the group. Participants in the second study group will continue to receive standard care. Participants will be required to complete some questionnaires at completion of treatment and 6 weeks later in order to evaluate their participation in everyday activities, health-related quality of life, fatigue and distress.

Influenza vaccination is recommended during pregnancy to protect 1. pregnant women 2. unborn babies and 3. infants within the first 6 months of life. Because of this “3 for 1” protection, the World Health Organisation prioritises pregnant women as highest among those who should receive influenza vaccination. Influenza vaccine prevents infection complications including critical maternal illness and death, stillbirth, fetal growth restriction, premature birth and serious infection in the first 6 months of life. Babies under the age of 6 months are too young to receive influenza vaccination directly. But babies whose mothers were vaccinated are protected in three ways: 1. antibodies which have crossed the placenta during fetal life stay in babies’ blood for up to 6 months 2. babies get more antibodies in breast milk 3. the baby is “cocooned”, meaning that he or she is unlikely to become infected with influenza from their nearest adult contact, their mother. Despite well studied safety of influenza vaccination during pregnancy, midwives, obstetricians and pregnant women are not well informed about benefits and safety. Previous audits at Mercy Hospital for Women showed that patient information brochures, staff education and reminder stamps in antenatal clinic progress notes increased influenza vaccination from 30% to 40% between 2010 and 2011. By winter 2012, we could not show any further increase, despite hoping that more than 75% of new mothers would have had influenza vaccination before their babies were born. A significant group of pregnant women do not recall influenza vaccination being discussed by obstetric or midwifery staff during pregnancy. This project aims to increase awareness and discussion about influenza vaccination using a text message reminder to women booked to have their baby at Mercy Hospital for Women during the influenza season 2013 (approximately March to October). The text message will read “ Msg from Mercy Hosp: Flu vacc in pregnancy is good for mums & babies. Ask your midwife or dr. about it soon”. Text messages are a familiar sort of appointment reminder used by hairdressers, dentists etc. Audit of new mothers in 2012 found that 80% of women were interested in text, email or web-based reminders or information in additional to written information and talking with their doctor or midwife. Published research on text messages and vaccination in the United States also indicate around 80% uptake and even higher levels of acceptability for pregnant women and families with children. The Mercy Hospital for Women already uses a text message service for the nurse bank. Pregnant women will only be contacted if their privacy consent permits the hospital to contact them. Pregnant women will only be contacted if their mid trimester ultrasound indicates reassuring fetal development. In this way, women who have already suffered a miscarriage will not receive a text message. Women with significant fetal anomalies will not be contacted as part of research. Such women are usually referred to Perinatal Medicine where influenza vaccination is also offered as part of routine care. We plan to assess influenza uptake by auditing new mothers on the postnatal wards in July and/or August 2013. Almost identical audits occurred previously in 2010, 2011 and 2012 using a 5minute interview technique which has previously been well received and been able to gain the views of 95% or more new mothers about why or why not they chose vaccination. No identifying data is collected but summary data is important for quality improvement.

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.