ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31604 results sorted by trial registration date.
  • PEACE – Palliation in Gynae-oncology: Patient Expectations and Assessment of Care

    This study will investigate the feasibility of collecting data on the satisfaction of end of life care from patients with advanced gynaecological malignancies. Who is it for? You may be eligible to join this study if you are aged 18 and above, have advanced gynaecological malignancy and a life expectancy of approximately 4 months as estimated by your treating physician. Study details All participants and their carers in this study will be asked to answer questionnaires about their experiences with the palliative care process, satisfaction with care and symptom management towards end of life. Patients and carers are expected to complete questionnaires at screening and every 8 weeks until the death of the patient. It is hoped that this research can provide preliminary insight on the satisfaction and expectations of care of patients with advanced gynaecological cancer, to inform future research aimed at understanding these issues fully and addressing unmet needs.

  • Effect of exercise on cancer therapy related cardiac dysfunction in women with breast cancer undergoing chemotherapy

  • The Break-Fast study: Effect of a protein-rich breakfast on autophagy in fasting healthy people.

    Autophagy is a critical process that helps keep the body’s cells clean and healthy. It is thought to be sensitive to nutrition. Using a test that we have developed to measure autophagic activity in humans for the first time, this project aims to determine whether autophagic activity in the blood is changed after healthy study participants have consumed a drink containing 30 g of whey protein compared to a fasted state. Our hypothesis is that autophagy is inhibited after a protein-rich drink in fasting healthy humans. Target sample size is 40, however HREC approval obtained to recruit between 40-60 participants as necessary.

  • Mind, Body, and Well-being in Young Men and Women: Exploring the Efficacy of a Brief Meditation Intervention

    The current study will investigate whether listening to self-compassion (SC) meditation audio recordings will increase levels of body appreciation (BA) and well-being (WB) whilst reducing body dissatisfaction. This experimental design will establish a cause and effect relationship of SC mediation on self-reported BA. A screening survey will ask whether participants have been diagnosed with an anxiety or eating disorder. Participants selecting yes on either question will be ineligible to participate further. The preliminary screening survey will also contain items from the Anxiety subscale from the DASS-21 and the EDE-QS, where if participants score greater than 15 (DASS) or greater than 15 (EDE-QS), they will be ineligible to participate further. Random allocation of participants will then occur. Those in both groups will complete the pre-intervention survey containing established measures of body appreciation, body dissatisfaction, self-compassion, and positive psychological wellbeing. Those in the experimental group (EXG) will then be provided links to audio recordings of self-compassion meditations which they are required to listen to daily for 3 weeks. Email and text reminders with the audio link will provided. After 3 weeks, participants from both groups will complete the post-intervention survey. Participants in the waitlist control group (CG) will then have be provided with links to the meditation recordings and will undergo the same intervention program as those in the main intervention group. Reminders with the link to the audio will be provided. 6 weeks after completion of the post-intervention survey, those in the EXG will be required to do a follow-up survey to determine if any improvements are maintained over time. Those in the CG will not do a follow-up survey. The project will yield information about factors facilitating positive body image, which could help with designing interventions based on risk factor models.

  • Collaborative and Proactive Solutions for irritability in children and adolescents

    Irritability is a highly prevalent, transdiagnostic symptom present in many commonly diagnosed child mental health disorders that confers risk for future anxiety, depression, and suicidality. Approximately 30-50% of children referred to mental health services experience severe irritability and irritable children place a high burden on the healthcare system with up to 15 times more service usage than children with mental health problems who are not experiencing irritability. There are currently no evidence-based treatments available that effectively reduce irritability and associated impairments. We will conduct a randomised controlled trial to test the efficacy of a psychological intervention, Collaborative and Proactive Solutions, for irritability in children and adolescents aged 5-15 years compared with usual care in terms of reducing irritability, and improving broader child and family wellbeing. Children referred to outpatient and community mental health services will be assessed for clinically significant irritability. Eligible children will be randomised to the CPS intervention (n=80) (8 sessions over 10 weeks) or usual clinical care from the mental health service (n=80). All participants will be assessed 4 and 12 months post-randomisation.

  • Resistance training for type 2 diabetes

    This study compared the effects of eccentric and concentric resistance training on diabetes markers, lipid profile, physical function, strength and body composition in patients with type 2 diabetes. Participants were randomly allocated to an eccentric or concentric group. Both groups performed supervised one-on-one resistance exercises consisting of eccentric-only contractions (5 seconds) or concentric-only contractions (1–2 seconds) of chest press, lateral pulldown, bicep curl, triceps extension, leg extension, leg curl, calf raise and abdominal crunch exercises , twice a week for 12 weeks. Outcome measures included blood markers, muscle strength, physical function and body composition were assessed pre intervention, mid intervention and post intervention.

  • Effects of Therapeutic Ultrasound on Breastmilk Composition

    Inflammatory conditions of the lactating breast (ICLB) can affect up to 33% of breastfeeding mothers in the early post-partum period and are associated with pain, redness, flu-like symptoms, and fever. Physiotherapy intervention has an important role in the treatment of ICLB, which most commonly includes therapeutic ultrasound (TUS). TUS can produce heat and other non-thermal effects through sound wave energy which may assist in resolution of ICLB by reducing inflammation, accelerating tissue healing, clearing blocked ducts and other antimicrobial properties. Breastmilk contains numerous important components that combine to create the optimal nutritional source for infants. The most abundant of these components include water (87%), lactose (7%), fat (4%) and protein (1%). As TUS generates heat in the lactating breast, there is concern from Physiotherapists providing TUS and the mothers receiving it, that breastmilk composition may be affected. This is a quasi-experimental study with pre-post measures taken in a single session. Mothers will provide hand expressed breast milk samples pre and post application of continuous therapeutic ultrasound at 1MHz and at the highest clinically used intensity within Australia of 2.2Wcm2. Protein (g/L), lactose (g/L) and fat (g/L) concentrations will be analysed from the milk samples collected before and after TUS. The primary hypothesis of this study is that protein, lactose and fat concentrations within breastmilk will not change significantly before and after the application of TUS to the breast.

  • Choosing your own digital intervention for recurrent binge eating

    In digital intervention trials for binge eating, each participant is provided with a standard program. This one-size-fits-all approach does not take into account participant preferences and needs. One way to potentially improve treatment outcomes and increase intervention usage is to give participants the opportunity to select from multiple digital intervention programs based on their preferences, needs, and symptom profile. Whether such preferences can translate to better outcomes has yet to be demonstrated. In this trial, we will experimentally test whether treatment outcomes can be improved by allowing participants to choose which intervention program they want to work through. The following hypothesis was derived. Participants allocated to the preferred condition (i.e., can select from two digital programs they want to receive) will demonstrate better retention, engagement, and primary and secondary symptom reduction than participants allocated to the forced condition (i.e., where they will be administered one of the two digital programs at random).

  • Screening and Support for Health and General Anxiety at the Prince of Wales Hospital - An Exploratory Study

    This project aims to examine the acceptability of new treatments for health anxiety in a medical outpatient setting. It will also link participant data to NSW Health records to examine trends in hospital usage. The study can be broken into three parts. Screening (Step-1) - patients attending one of four clinics at the Prince of Wales Hospital asked to complete digital screening for health anxiety. We hypothesise that: 1. Digital screening for anxiety will be acceptable to medical outpatients. 2. Between 20-25% of medical outpatients will have elevated anxiety scores. SHAPE Pilot (Step-2)- those who are identified to have elevated health anxiety will be called by a researcher and invited to partake in an iCBT intervention or intervention with a clinician. Follow-up measures will be taken at 6, 12, and 24 weeks to monitor the effect of the interventions. We hypothesise that: 1. The novel care pathway for health anxiety will be acceptable. 2. The novel care pathway for health anxiety will result in a reduction in health anxiety measures. Data linkage- We will collaborate with the Centre for Health Record Linkage (CHeReL), to link participant data to data regarding health care utilisation. This will be used to examine relationships between health anxiety and health care utilisation. We hypothesise that group level data linkage will show: 1. Higher rates of health care utilisation according to health anxiety self-report measures. 2. Concordance between actual and self-reported rates of health care utilisation in general.

  • Kaat Koort: Examining the impact of a program targeting cardio-metabolic risk and lifestyle changes on heart and brain health among Aboriginal and Torres Strait Islander people

    Limited data that are available indicate that Indigenous Australians have a dementia prevalence three times higher than the general Australian population. The major risk factors for dementia and cognitive decline – the slowing of brain function and memory – are known and are elevated in older Indigenous Australians. Many of these risk factors can be targeted for prevention. During the recent two decades, several studies have shown a relationship between the development of cognitive decline and dementia with lifestyle-related risk factors, such as: physical inactivity, tobacco use, unhealthy diets, and harmful use of alcohol. Certain chronic conditions are also associated with an increased risk of cognitive decline and developing dementia, including hypertension, diabetes, hypercholesterolemia, obesity and depression. Other potentially modifiable risk factors are social isolation and cognitive inactivity. The existence of potentially modifiable risk factors means that prevention of cognitive decline and dementia is possible through a public health approach, including the implementation of key interventions that delay or slow cognitive decline. Prevention of dementia and cognitive decline requires the management of cardiovascular risk factors and dementia-specific risk factors, as well as building on current primary care interventions. Rather than address individual risk factors in isolation, our study is planning to adopt a multi-domain approach that targets multiple risk factors simultaneously to maximise the potential for risk reduction.

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