ANZCTR search results

The purpose of this study is to evaluate the impact of an evidence-based, cancer pain assessment mobile health clinician education program, on patient reported pain outcomes. Who is it for? You may be eligible for this study if you are a medical/nursing staff member routinely caring for cancer or palliative care patients Study details Participants in this study will be randomly assigned (by chance) to one of two groups. One group will receive the intervention, which is a pain assessment performance feedback program delivered using the Qstream platform on their mobile phone or via email. The other group will receive their standard in-service and be offered the intervention after 16 weeks. Participants will complete an online survey at two points in the study. It is hoped this research will prove this mobile-health education program will be found efficacious and cost-effective.

The loss of a pregnancy, whether spontaneous or induced for medical reasons, is a very traumatic event for the parents. In many cases, the reasons for a fetal abnormality or miscarriage are not clear, but can be very important for future pregnancies and patient counselling. Fetal autopsy is performed (with parental consent) as often as possible, but some parents cannot consider autopsy at a very stressful time in their lives, and others cannot consent for cultural or religious reasons. Some of these parents will allow an external examination and x-rays which provide only limited information. The use of multi-detector computed tomography (MDCT) is well established in forensic science units around the world. To date, there has been very little research into the value of MDCT in fetal deaths. A recent article by O’Donoghue et al. used MDCT as an adjunct to autopsy in the investigation of 3rd trimester stillbirths, finding good correlation between measurements obtained in both settings, although only half their cases underwent formal autopsy.1 We aim to investigate the value of MDCT as part of the investigation into fetal abnormalities and pregnancy losses in the 2nd and 3rd trimesters, and early neonatal period. While we do not propose to replace conventional autopsy, we hope to show a good correlation between radiological and pathological findings, so that we can offer a non-invasive alternative to autopsy where the parents cannot consent to dissection. 1. O'Donoghue K, O'Regan KN, Sheridan CP, O'Connor OJ, Benson J, McWilliams S, Moore N, Murphy MJ, Chopra R, Higgins JR, Maher MM. Investigation of the role of computed tomography as an adjunct to autopsy in the evaluation of stillbirth. Eur J Radiol. 2011 Apr 29. [Epub ahead of print].

Introduction: Osteoradionecrosis (ORN) of the mandible is a painful and debilitating condition frequently occurring after radiotherapy to the head and neck to treat cancer. For decades Hyperbaric oxygen (HBO) has formed the mainstay of non-surgical management of ORN. Literature about the efficacy of HBO is contentious. Recently a combination of medications known as PENTOCLO has shown promising results in treating ORN. The purpose of this pilot study is to generate a hypothesis that can be tested in larger multi-centre controlled trials. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with osteoradionecrosis by an Oral and Maxillofacial surgeon. Study details For this pilot study, we will recruit 16 participants. These participants will be randomly allocated to up to 18 months of either Hyperbaric Oxygen or PENTOCLO treatment after completing 4 weeks of ‘pre-treatment’. Pre-treatment involves taking daily medications (Amoxicillin + Clavulanic acid, Fluconazole, and Prednisolone) for 4 weeks, with the overall goal of reducing inflammation, infection and pain. Participants will have an initial appointment to take some measurements and record their medical history as well as having X-rays of their jaw taken. They will then be followed up at two weeks, four weeks, six weeks, eight weeks, twelve weeks, six months, nine months, twelve months and eighteen months and have photographs and a further assessment at each visit. Further X-rays will be taken throughout the follow-up period according to when they are needed such as if a participants condition improves or worsens. No other tests need to be performed during the study. It is hoped that this research will help us to conduct much larger studies in the future about whether each treatment is suitable for use in Australia as well as providing international doctors and patients with meaningful information about which treatment for ORN is better. This will help to improve the lives of patients currently suffering with ORN and those who may develop the condition in the future by limiting their pain and suffering. Ethics and dissemination: This study will be registered with the clinical trials database of the TGA in Australia as well as the Australian New Zealand Clinical Trials Registry of the NHMRC. Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications.

Bowel cancer is the second most common form of cancer in Australia, and screening can substantially reduce both mortality and health care costs. However, participation in the Australian National Bowel Cancer Screening Program (NBCSP) is quite low, with only around 39% of invitees taking up screening. This research investigated how screening rates might be increased by asking participants to think about the regret they would anticipate in the future if they chose not to screen. Earlier studies have shown that just thinking about this anticipated regret can increase the likelihood of participation in a range of protective behaviours like screening.

A common but likely erroneous belief is that using exercise as a treatment for knee osteoarthritis will cause damage to an already worn joint. We propose to perform the first RCT to examine the effect walking has on knee structure, objectively assessed using MRI. Participants will be randomised to either community walking plus usual care or usual care alone for 6 months. Participants randomised to walking will walk 3 days/week for one hour (2 days/week supervised group sessions and 1 day/week unsupervised). Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients. The aim of this study is to generate pilot data for a proposed larger study (which aims to enrol a total of 186 participants, funding applications currently under consideration) to demonstrate feasibility of the study design, recruitment, screening, adherence, safety and retention. This pilot study will enrol 48 participants (24 randomised to walking plus usual care and 24 to usual care). It will be conducted in line with the recent CONSORT statement for pilot and feasibility trials.

We hypothesise that a minimal, mobile shoe design will increase foot and lower limb muscle strength and performance outcomes in children compared to standard school shoes, over time. To test this, we are measuring the change in children after ten months of wearing two very different shoes to school; one group in the common school shoe and the other in a very mobile shoe. We hope that this will scientifically inform future shoe design, which is currently not well understood for children.

This research study is examining whether patient education booklets and videos are a clear and informative way of communicating information about the safety, effectiveness, accessibility and affordability of experimental stem cell treatments (i.e. stem cell injections to the brain, spinal cord, vein, artery or stomach) offered by private clinics in China, India, Russia and South America.

Children diagnosed with mild obstructive sleep apnoea are enrolled and randomised to one of three treatment groups: 1) NS = with nasal steroids alone, 2) NS+AL = nasal steroids plus a leukotriene receptor antagonist, or 3) AD = to surgery with adenoidectomy alone. The aim was to determine whether treatment with surgery (adenoidectomy) or treatment with nasal steroids plus a leukotriene receptor antagonist has clear benefit compared to treatment with nasal steroids alone.. As steroids are routinely used as the first treatment in this disease, outcomes from the surgical and combined treatment (nasal steroid plus leukotriene receptor antagonist) groups will be compared against the group using nasal steroids alone (the comparison group).

AIM To assess whether Drug Eluting Angioplasty Balloons (DEB) prevent recurrent narrowing in Arterio-Venous Fistulas (AVF). The study is an investigator initiated, prospective, double blinded, randomised, multicentre, control trial conducted at 3 Australian institutions BACKGROUND When a patient’s kidneys fail, they will die unless some form of “renal replacement therapy” is provided. Haemodialysis is a mainstay treatment in renal failure to keep patients alive in the short and long term. Haemodialysis occurs when the patient’s blood is “washed” in a haemodialysis machine, which takes the place of the patient’s failed kidneys. The biggest problem with haemodialysis is “haemodialysis access” i.e. repeatedly (3 to 5 times per week) placing two large bore needles into the patient’s blood vessels to circulate their blood through the haemodialysis machine. The best form of haemodialysis access is the AVF - a swollen vein created surgically on the patient’s arm. The commonest problem with the AVF is the development of narrowings (stenoses) in the AVF. This prevents proper haemodialysis – an immediately life threatening situation - and can lead to destruction of the AVF. AVF stenoses are readily treated with angioplasty balloons – small balloons placed inside the narrowed part of the fistula – which “stretch” the narrowing and restore the AVF’s function. The problem with this angioplasty treatment is that the body will attempt to “heal” the “stretched” narrowing and the narrowing will recur (restenosis). As a result, many haemodialysis patients require repeated treatments. A new technology – DEB – has emerged to prevent this restenosis problem. DEBs are angioplasty balloons covered in a drug – Paclitaxel for our study – that blocks the restenosis process. The DEB is placed in the AVF immediately after a narrowing has been treated in the hope that it will prevent restenosis. In the last 6 years, a similar technology - Drug Eluting Stents - have decreased restenosis after coronary artery angioplasty from 20% to 5%. The use of Drug Elution in the AVF has not yet been investigated. METHODS We propose a multicentre, randomised control trial, comparing AVF stenoses treated with standard angioplasty techniques to AVF stenoses treated with standard techniques plus a DEB. All trial patients will have their AVF stenosis treated by our current standard angioplasty protocol. In addition, the STUDY GROUP and will receive a DEB to the treated stenosis and the CONTROL GROUP will receive a sham balloon. Patients will be followed up with ultrasound of their fistula for one year to see if there is a difference in the rate of re-narrowing (restenosis) between the two groups.

*The aim of this study is to examine whether an innovative mobile health (mHealth)-enabled care program (MH-COPD) will improve patient self-management and relevant health outcomes. *We expect that the MH-COPD program would increase the self-management of COPD patients and consequently improve health outcomes.