ANZCTR search results

The purpose of this study is to determine incidence and clinical outcomes of KRASG12C mutated advanced non-small cell lung cancer patients in Australian cancer therapy centres. Who is it for You may be eligible for this study if you, were diagnosed with advanced NSCLC with the presence of a KRAS G12C mutation between Jan 2018 and Dec 201 , and are a patient at one of the participating sites. Study Details Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. Enrolled participants will have clinical data collected from one time point from their medical record. Data captured will include patient characteristics, disease characteristics, surgical and or drug treatments administered, survival, and treatment outcomes. Data will be collected at a single point by study personnel from the patient medical record. This study aims to help Oncologist better understand the incidence, demographics, disease characteristics and survival outcomes of KRASG12C mutated advanced NSCLC in Australia. This may ultimately lead to improved standard of care practices which will improve patient outcomes.

This project will evaluate the feasibility of the use of a mobile health application (mHealth app) as an effective secondary prevention program for people in remote and rural Queensland who have experienced a cardiovascular event. This study will evaluate feasibility of methods and procedures for a large trial, using pre-defined criteria for recruitment (>80% approached recruited), retention (>80% participants complete study phases), protocol fidelity (>90% of participants receive allocated intervention for entire study). This study will provide information on the resources and management required for a larger efficacy RCT. Secondary prevention outcomes (i.e., depression, quality of life, cardiovascular clinical and lifestyle risk factors, functional capacity, & medication adherence) will be collected. Participants will be randomised to receive either standard care (nurse telephone follow-up and referral to secondary prevention program 8-12 weeks), or the mHealth program (mHealth app [includes weekly nurse mentoring] & standard care). Approximately 60 participants will be recruited to the study.

The purpose of this phase I open-label safety trial is to assess the safety of a traditional Chinese medicine (TCM) herbal formula, containing Alisma orientale, Prunus armeniaca, Cyperus rotundus and Atractylodes macrocephala, in healthy adults aged 18-60 years old. Twenty participants will be recruited, 10 will receive 1 capsule per day, 10 will receive 2 capsules per day for a 15 day period. We hypothesize that the TCM herbal formula is safe and will not cause serious side effects.

This pilot cluster randomised controlled trial (CRCT) will examine the use of smoking cessation training and the dissemination of cessation resources by participating Health Professionals (HPs). In addition, surveys of Aboriginal patients will seek to understand their experience and feelings following their smoking cessation counselling from trained HPs. Health Professionals consult with large numbers of patients each year and are perceived as influential sources of information for smoking cessation (Zwar et al., 2009). The literature shows that individual counselling from smoking cessation specialists increases the chances of successful abstinence compared with less intensive support (Fiore et al., 2008, Lancaster and Stead, 2008). This is supported by a Cochrane meta-analysis, where the Coordinating Primary Investigator (CPI) identified that even training of short duration (a one-off session of 2-3 hours) can have substantial implications for quit attempts amongst patients of HPs (Carson et al., 2012, & unpublished data). Furthermore, research articles report that training HPs in smoking cessation counselling programs enhances the knowledge, skills and confidence required to deliver optimal smoking cessation advice and support to patients (Carson et al., 2012). Essentially, smokers are more likely to quit if asked, and HPs are more likely to ask if trained. This project contains a pilot CRCT to assess impact of the ‘Kick the Smokes’ culturally safe smoking cessation training and resources on Health Professional practices. This CRCT itself is nested within a larger feasibility study to determine whether the method developed can be upscaled in to a larger full-scale CRCT

To investigate the acute effect of the UnderCool 2.0 cooling vest during high-intensity exercise in a heat sensitive MS population on; i) body temperatures and sweating, ii) feelings of exertion and hotness, iii) MS symptoms that are aggravated by heat, and iv) Concealability, comfort and functionality. With a controlled, cross-over design, 20 participants diagnosed with MS will complete four high-intensity interval cycling sessions on separate days including familiarisation and three experimental trials with participants wearing either; i) an UnderCool 2.0 cooling vest, ii) a CryoVest Comfort cooling vest (current evidence-informed practice), or iii) no vest. The exercise sessions will be high-intensity interval cycling sessions of 45 minutes in controlled conditions (22°C, 40% relative humidity). Exercise intensities will be standardised across all trials. It is hypothesised that compared to control, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 1) Attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 2) Attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 3) Reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency It is further hypothesised that compared to the CryoVest Comfort, during high-intensity exercise, the UnderCool 2.0 cooling vest will: 4) Improve perceptions of concealability, comfort, functionality and intention to use 5) Similarly attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate 6) Similarly attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and 7) Similarly reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of durvalumab plus chemotherapy in patients with with extra-pulmonary small cell carcinoma. Who is it for? You may be eligible to join the study if you are aged 18 years and older and have recently been diagnosed with extra-pulmonary small cell carcinoma. Study details Participants will receive durvalumab and chemotherapy. Durvalumab is given by infusion every three weeks, and chemotherapy will be given by infusion every three weeks for the first 4 doses. After the combination completes, you will receive durvalumab every 4 weeks, for as long as you are tolerating the treatment well and the cancer is under control. Participants will undergo clinical assessments at 3-4 weekly intervals from first treatment until end of treatment. Safety and tolerability of treatment will be assessed at 3-4 weekly intervals. Health related quality of life during treatment will be assessed at 3-4 weekly intervals while on treatment and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that durvalumab and chemotherapy will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Health literacy refers to a person's ability to find, understand and use health information. Many studies show that people with lower health literacy also have poorer health outcomes, yet this is relatively unexplored among people with heart disease. The aim of this research project is to see if health literacy affects people’s future hospital admissions, the cost of health care, and their quality of life following a heart attack. The study findings may help us identify how best to address health literacy barriers to lifestyle change following a heart attack.

The purpose of the study is to evaluate whether a specific AI technique (multi-arm contextual bandit combined with an adaptive group sequential study trial design) can be used to efficiently identify how well interventions work in a multi-arm randomised controlled trial in a mental health context. To test this idea, the study is comparing the effectiveness of three brief self-guided smartphone interventions based on mindfulness, physical activity and sleep hygiene, and an active control of mood monitoring (i.e. ecological momentary assessment), in reducing self-reported psychological distress in university students. Based on past research, we hypothesise that the mindfulness and physical activity conditions will be more effective than the sleep hygiene and active control conditions. We hypothesise that the novel method used in this study will be able to efficiently determine the effectiveness of the interventions.

Approximately 25% of all medicine is broken down by liver enzymes called CYP2D6 and CYP2C19. In many people these enzymes work more slowly than normal causing particular medicines to accumulate in the body at concentrations higher than intended. In some people these enzymes work too quickly, clearing some medicines before they can work. This type of testing is called precision medicine. Recommendations based on a genetic test may suggest an increase or decrease in medication or that a medicine not be used and that an alternative be prescribed. Numerous genetic studies have shown that a significant number of prescribed medicines are ineffective or cause negative side effects. This study aims to improve the genetic methods used to guide and inform medicine prescriptions. Precision prescriptions may reduce side-effects and increase symptom relief for many individuals. In the main research project, the randomised controlled trial (phase 2) of the Precision Medicine Pathway, we are testing whether genetic testing which determines how well the liver processes medication when given to the participant and their psychiatrist, actually influences any changes in prescribing and in so doing reduces psychiatric symptoms, improves the severity of the illness and quality of life. Understanding a person’s genes may be able to explain why some people respond to a treatment, while others do not, or why some people experience a side effect and others do not. In this second part of the research project we would like to talk to some of the participants, their carers and the research and clinical mental health staff involved in the project to learn whether the genetic information was beneficial or not, and whether there were any barriers or difficulties being involved in the process of the Precision Medicine Pathway including saliva collection, filling in questionnaires, and receiving the information from the genetic testing. We would also be interested in whether any improvements could be made in any of these processes.

This 12-month pilot trial at Southern Adelaide Local Health Network Emergency Departments (EDs) will build upon the successful ED-SAFE trial in the United States which reduced the number of people attempting suicide in the 12 months after discharge from 8 hospital EDs. The interventions included post ED phone counselling and involvement of a family member over a 12 -month period. The Southern Adelaide mental health team have implemented post ED Improving Access to Psychological Therapies (IAPT) phone delivered cognitive behaviour therapy (CBT) at the Flinders Medical Centre, which has resulted in a 59% recovery rate for anxiety and depression. IAPT was also used for the Beyond Blue New Access project with nearly 4000 participants achieving recovery from anxiety and depression of 68% with no suicides . Surprisingly few trials of suicide prevention have included a family member. In this pilot trial, the intervention (IAPT-M), provided over 6 months will consist of 3 evidence-based modifications to standard IAPT: a) 7 sessions of guided self-help CBT focussing on suicidal ideation and problem solving, b) 4 sessions involving a family member, and c) personalised text messaging and use of Mindtick app to monitor mood and activity In this 12-month study period, 10-15 people with suicide attempts presenting to an Emergency Department will be offered a 6 month intervention (IAPT-M) followed for a study period of 10 months with the primary outcome being suicidal ideation and suicide attempts. This phone delivered service can be scaled up to be provided to any Emergency Department in Australia.