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Coping-Together: A study to help couples manage a recent cancer diagnosis
Expand descriptionThis study will test the efficacy of Coping-Together – a couple-based self-directed, coping skills training intervention. It is anticipated that using the proposed Coping-Together skills will be associated with couples experiencing less anxiety. Who is it for? You may be eligible for the study if you have recently been diagnosed with Stage I, II or III breast, prostate or colorectal (bowel) cancer, or melanoma and are currently receiving or planning to receive treatment. Your partner must also be willing to participate and you must both be able to understand and complete surveys. Trial details: You will be randomised to one of two treatment conditions, either the Coping-Together intervention or to the Minimal Ethical Care condition. The purpose of the study is to test the suitability of the information resources and assess which condition enhances illness adjustment and coping with cancer. All groups will be supplied with cancer and coping information, which participants work through at their own pace. What are you being asked to do? To participate in this study you will need to complete 4 surveys and receive an orientation call from research staff over a 6 month period. You are also asked to use the information resources provided as much as possible.
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Assisting parents of children with autism to make intervention decisions by improving their health literacy about evidence
Expand descriptionThe project aims to test the effectiveness of an interactive, web-based decision aid for parents of children diagnosed with autism via a randomised controlled trial (RCT). METHOD Following interview and baseline administration of outcome measures, participants who are randomly allocated (using a pre-prepared random numbers table) to the Intervention Group will receive the web-based/electronic educational intervention/ decision-aid. Participants in the Control Group will receive usual care (that is, standard information from autism advisors and other professionals as currently occurs. Three (3) months following baseline assessment, outcome measures will be readministered to all study participants, and interviews once again conducted to obtain information about decision-making processes and choices made regarding interventions. On completion of data collection for the trial, parents in the Control Group will be offered the opportunity to receive the educational intervention. PARTICIPANTS 150 parents/ carers of children newly diagnosed with autism will be invited to participate in the trial (N=75 per group). Participants will be sourced from all Australian states and territories, and will be parents (most likely mothers) of a child (or children) who is/are less than 7 years old and who has been diagnosed with an Autism Spectrum Disorder (ASD) within the past 12 months. To account for anticipated attrition, 10 additional participants will be recruited to each group. Participants will be recruited via newsletters and websites of ASD organisations in each state and territory, in addition to early childhood/ special education facilities, and other support agencies for children with autism spectrum disorders. INSTRUMENTS To ensure that the children of participants meet the diagnostic criteria for ASD, parents will be asked to complete a parent report diagnostic tool called the Gilliam Autism Rating Scale (GARS). Demographic data (e.g. age, gender, educational level, household income bracket, length of time since child’s diagnosis)) will be collected for each participant, and a telephone interview conducted before and after the trial to obtain information about which autism interventions had been considered/ trialled and reasons for the selection of various interventions. Health literacy levels will also be measured using the REALM. The primary outcome measure will be the Decisional Conflict Scale (DCS) (O'Connor, 1993 (updated 2010)). It will measure participant’s self-efficacy with decision-making, factors affecting decision-making, and satisfaction levels in relation to decisions made (O'Connor, 1993 (updated 2010)). Because this scale will be used to measure decision-making before and three months following receipt of the intervention, responsiveness to change is relevant. The DCS requires participants to read and respond to 16 items across five (5) subscales (Informed, Values Clarity, Support, Uncertainty, and Effective Decision), by ticking boxes marked Strongly Agree, Agree, Neither Agree Or Disagree, Disagree and Strongly Agree. Secondary outcome measures will be a Likert scale measuring self-efficacy specifically for accessing educational information, and the Parenting Sense of Competence Scale (PSOC) (Johnston & Mash, 1989). This tool contains 16 items across two scales, which address parents' perceived competence, problem-solving ability, capable parenting, value/comforting, and parental frustration, anxiety and motivation. This self-report tool will be used to evaluate parent efficacy and satisfaction before and three months post trial. DATA ANALYSIS Statistical software will be used to calculate between-group differences post-intervention (using either paired t-tests or ANCOVA) and regression coefficients will be used to determine which predictor variables (such as intervention, parental level of education etc) influence decisional conflict (decision-making) as the outcome variable. ADDITIONAL INFORMATION Upon completion of the study, it is anticipated that information regarding this resource, if proven effective in improving parents' ability to make informed decisions, will be distributed by the health professional or health care team involved in supporting parents during and after autism diagnosis. The resource will also be made available freely online. The website hosting the decision-aid will be optimised to ensure that parents seeking information on the internet using frequently used keywords, will find the relevant webpage within the top search results.
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Examining decision-making using transcranial direct current stimulation
Expand descriptionOne of the main symptoms of Major Depression is Anhedonia, or a reduced ability to experience pleasure. Anhedonia can reduce one’s motivation to engage in pleasurable activities as well reducing the sense of enjoyment they experience from activities that would typically give them pleasure. As such, it is likely that anhedonia can influence our day-to-day decision-making choices as well. Prior research has shown that transcranial direct current stimulation (tDCS; a research tool that involves applying low-voltage electrical stimulation to electrodes placed on the scalp) can alter cognitive processing and decision-making in humans. The goal of the present study is to investigate how tDCS to part of the brain known as the dorsolateral prefrontal cortex (DLPFC) can influence economic and social decision-making behaviour in individuals with anhedonia. By comparing the effects of tDCS on healthy people with varying levels of anhedonia, we hope to better understand the role of the DLPFC in decision-making, and how this is modulate by anhedonic symptoms. The use of electroencephalography (EEG; a research tool that involves recording brain waves from electrodes placed on the scalp), in this study may help us gain a better understanding of the neurological basis of decision-making, and how this is affected by anhedonia. The hypotheses of the study are that participants receiving tDCS treatment designed to simultaneously increase activity on the right side of their brain and decrease activity on the left side of their brain will (compared to participants receiving tDCS treatment designed to simultaneously decrease activity on the right side of their brain and increase acitivitry on the left side of their brain), be more willing to accept unfair offers to distribute a sum of money and less willing to place a risky bet when playing a gambling game. We also hypothesize that variations in participants' anhedonia levels will affect their behaviour in these tasks; individuals with higher anhedonia levels are hypothesised to show increased acceptance of unfair offers and a decreased willingness to play a risky bet.
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High Dose Melphalan: A pilot study to evaluate pharmacokinetic-based dose determination in patients with multiple myeloma scheduled to undergo autologous stem cell transplantation
Expand descriptionThe aim of this study is to evaluate whether a test dose of melphalan can be used successfully to target a desired exposure in patients with multiple myeloma scheduled to undergo autologous stem cell transplantation. Higher drug exposure is associated with improved disease control and survival post transplant. Who is it for? You may be eligible to join this study if you are a male or female of any age who is scheduled to receive single agent high dose melphalan and autologous stem cell rescue for multiple myeloma. Trial details All participants in this trial will receive a test dose of 20 mg/m2 melphalan 4 days prior to scheduled autologous stem cell transplantation. This drug will be administered intravenously (i.e. into the vein). A series of six blood samples will be collected after the test dose to allow pharmacokinetic assessment and predictions of exposure for the full dose. The treating clinician will decide the actual full dose to be administered. Whatever dose is given, blood sampling and pharmacokinetic assessment of the full dose will allow determination of whether the test dose exposure accurately predicts the full dose exposure. The test dose amount was increased from 10 mg/m2 in an amendment which was approved in December 2013 to improve the quality of the predictions.
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Acceptance and commitment therapy: Evaluation of a novel approach to enhance the quality of life of aged care residents
Expand descriptionThis project aims to evaluate the effectiveness of acceptance and commitment therapy (ACT) in improving the quality of life and mental health of older adults living in aged care facilities. We also aim to determine the feasibility of this approach when implemented as part of a psychology student placement program and its acceptance to older adults and their professional carers. Older adults living in residential care facilities often report poor quality of life and are at a high risk depression and anxiety. Despite this, this population has very limited access to nonpharmacological interventions and support. Our team is currently establishing a placement program for Doctor of Psychology (Clinical) candidates, who will deliver a structured program of ACT to residents across three aged care facilities, under supervision, in 2013. This therapy has proven effective and popular for use with younger adults, but has not yet been evaluated in aged care settings. The placement program offers an opportunity for future clinical psychologists to gain experience in working with older adults, and helps address the shortage of trained mental health clinicians in aged care settings. This study will use a randomized controlled design to evaluate the effectiveness of this student-led intervention in improving quality of life, as well as reducing symptoms of depression and anxiety, compared to a control group. The results of this study will be used to inform our future training program, as well as contribute to the literature on the effectiveness of psychological interventions with older adults residing in residential care settings. Participants will include 36 aged care residents who will be randomly allocated to the intervention or control group, with control participants offered the intervention at the end of the study. The intervention consists of 12 individual 60minute sessions delivered by a student psychologist twice weekly. The intervention will be evaluated using measures related to quality of life, symptoms of depression and anxiety, with satisfaction and feasibility determined in postintervention interviews with the participants and facility staff.
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A pilot study of antenatal maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by preeclampsia (PAMPR Trial).
Expand descriptionThis research project will investigate whether the hormone, Melatonin, is a useful treatment for oxidative stress in pregnancies affected by preeclampsia. Preeclampsia is one of the most common diseases in pregnancy and is potentially very dangerous for both mother and baby. Oxidative stress in preeclampsia occurs when a pregnant mother and the baby in the womb are exposed to certain noxious chemicals produced by the placenta. Oxidative stress can cause serious damage to the mother and baby, including premature birth, brain damage and even death. Melatonin is a strong antioxidant and is been used to effectively treat oxidative stress in pre-clinical trials. It has also been studied intensively in both animals and humans and has shown to be very safe. In this trial, we hope to use melatonin to reduce the damage caused by oxidative stress during pregnancies affected by preeclampsia. To do this, we will give mothers diagnosed with preeclampsia melatonin (10mg) tablets three times a day. We will measure levels of oxidative stress before, during and after treatment in the mother's blood, as well as in blood from the placenta after birth. Other non-invasive measurements of mother and baby health will also be measured including the outcome of their pregnancies. This will give us an indication whether melatonin is helping to protect the unborn baby from oxidative stress. Participation in this project will be undertaken during the normal care of a woman with preeclampsia admitted to hospital. She will be cared for in the usual way with best practice and there will be regular blood samples twice per week as is normally done. Ultrasound scans to check the health of the baby will be done at least weekly. Samples will be taken from the maternal blood or from material that would normally be discarded. No samples will be obtained directly from the baby. If this project is successful, it will potentially give us the very first and only treatment for preeclampsia.
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Utilisation and Perceptions of Acupuncture and Foot Mobilisation by Australian Podiatrists.
Expand descriptionThe study aims to investigate the utilisation and perceptions of acupuncture and foot mobilisation by australian podiatrists. It is of our interested to find out how popular these relatively new techniques are among podiatists in Australia and whether these therapies are contributing to better patient care.
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STRIDE (Steps TowaRd Improving Diet and Exercise): an online lifestyle intervention for cancer survivors living in South Australia
Expand descriptionThe aim of the study is to test the effectiveness of an online resource to increase physical activity (primarily walking) and improve diet among cancer survivors living in South Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have any type of cancer (except skin cancer) treated with curative intent. You need to be a permanent resident of South Australia, and you should not be undergoing any active treatment. You will also require access to the internet. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in the intervention group will take part in a 12-week lifestyle program during which they will wear a pedometer and use an online resource. The main focus of the online resource is a step log where participants enter their daily step counts, perception of exertion and feeling daily. Based on this information they will be emailed weekly step count goals. The website will also include an interactive forum that links participants to other cancer survivors. There will be a virtual notice board where community service organisers can advertise events and activities relating to physical activity and healthy eating. Information on healthy eating will be provided based on the Cancer Council Australia's nutrition guidelines which supports the recommendations in The Australian Guide to Healthy Eating (developed by the Australian Government, Department of Health and Ageing). Participants are free to use (or not use) the program at their discretion. Participants in the other group will receive a pedometer only for the first 12 weeks, after which time they will be offered the full program. Health measures such as height, weight, blood pressure, waist and hip girth will be collected from each patient at the start and end of the program, and 3 months after program completion. Participants will also be asked to fill out questionnaires relating to their physical and psychological health.
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The PEBBLES study: Prevention of Eczema By a Barrier Lipid Equilibrium Strategy
Expand descriptionAsthma affects approximately 20% of children, is a common cause of hospital admissions, and we do not know how to stop children developing it. Infantile eczema is also common, affecting about a third of children. Infants with eczema often later develop asthma. It is hypothesised sensitisation to allergens can occur via damaged skin associated with eczema, which then increases the risk of asthma. If this hypothesis is correct, it may be possible to prevent asthma by improving the skin barrier function in infants. There is evidence that a ceramide based emollient (which contains the major components of skin) can improve skin barrier function, while current treatments for eczema do not. This study is aims to determine if twice daily application of a ceramide dominant emollient can improve infant skin barrier function and prevent the development of eczema in high risk children.
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A randomised control trial to determine whether “tapping” on a vein improves perceived ease of venous cannulation, and rate of successful cannulation in patients undergoing elective surgery.
Expand descriptionPeripheral intravenous cannulation is a commonly performed procedure. The insertion of an intravenous cannula is usually uncomplicated, however it can be difficult in certain patients, including hypovolemic or critically ill patients, IV drug users, patients having repeated courses of chemotherapy, and obese patients. Perceived ease and efficiency of cannulation is related to the experience of the cannulator. It has been shown that, when certain manoeuvres are performed, for example, warming the skin prior to insertion of a peripheral venous cannula, both the time taken for insertion and number of attempts required for cannulation are reduced. A randomised controlled trial evaluated ultrasound guided peripheral venous cannulation in patients with a history of difficult intravenous cannulation, however it found no significant difference between the two groups in time to successful cannulation, number of attempts or number of subjects in whom IV cannulation was successful on the first attempt. It is common practice for health professionals to tap a vein, prior to cannulation, on the assumption that it will improve the perceived ease of cannulation and therefore the likelihood of successful cannulation. This assumption is based on anecdotal evidence and a rigorous investigation of the effect of tapping of the vein on the time taken and the number of attempts required to cannulate has not been undertaken. The optimisation of conditions is important for this commonly performed procedure. Failed attempts at cannulation can lead to fear induced vasoconstriction by activation of the sympathetic nervous system, resulting in subsequent attempts being more difficult. Multiple attempts at cannulation are also unpleasant for the patient. We investigated whether or not tapping of a selected vein prior to cannulation improved the perceived ease of cannulation and the success of cannulation.