ANZCTR search results

The aim is to evaluate the efficacy of an online intervention program which is focused on reducing participants' sense of perfectionism and reducing subsequent behaviours and symptoms related to having high levels of perfectionism. The intervention will target individuals who are considered at risk of developing an eating disorder due to their current disordered eating behaviours, as perfectionism is thought to contribute to the development and maintenance of eating disorders. The trial will investigate whether using an online interactive program is more effective at reducing disordered eating symptoms compared to dydactic PDF handouts or a waitlist (control) condition. The trial will investigate the perfectionism intervention's efficacy by assessing participants' self-report measures of disordered eating behaviours and perfectionism. The content for the intervention is adapted from the self-help book “Overcoming Perfectionism” (Shafran, Egan, & Wade, 2010), which has been evaluated on numerous occasions, including online formats, and found to improve body image flexibility and decrease disordered eating. Session content covers: psychoeducation, self-criticism and self-compassion, unhelpful thinking styles, procrastination, self-worth, maintenance cycles, and perfectionism misconceptions. The content for the dydactic handouts can be accessed from https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Perfectionism

This study aims to evaluate the effectiveness of a combined 6 week Cognitive Rehabilitation and Psychological intervention delivered via Telehealth in improving patient outcomes post-stroke in a pragmatic randomised wait-list controlled trial. It is expected that the proposed intervention will improve patients’ cognition, psychological wellbeing, functional abilities and QoL. Eighty participants with a diagnosis of stroke within the previous 6-months and self-reported cognitive or psychological difficulties referred to the ISLHD Rehabilitation and Medical Psychology Department by multidisciplinary teams on Rehabilitation and Neurology wards within ISLHD, will be randomised to a 6-week combined Cognitive Rehabilitation and Psychological Telehealth Intervention or Waitlist Control Group. Participants will attend an assessment session prior to the Group, immediately following the Group, and at 3 months follow up after completing group, and will be assessed with a varied of neuropsychological tests (primary outcome measure being RAVLT) and psychological wellbeing measures (DASS-21) and quality of life(SF-36) .

The SOCRATES HCC study aims to investigate whether a radiotherapy technique (called Stereotactic Ablative Body Radiotherapy or SABR) can improve outcomes for people with early stage liver cancer compared to other current treatments. Currently, what treatment patients with early stage liver cancer are offered vary in individual circumstances but include; • Radiofrequency ablation (RFA) or microwave ablation (MWA) that use heating probes directly inserted into the tumour to kill the cancer cells. • Transarterial chemoembolisation (TACE) or transarterial radioembolisation (TARE) that uses chemotherapy or radioactive particles injected into the blood supply of the tumour to kill the cancer cells. • SABR is a highly precise radiation therapy technique that uses high energy x-rays focused on the tumour to kill the cancer cells. Who is it for? People who are 18 years of age or over AND have been diagnosed with primary hepatocellular carcinoma (single lesion with the largest diameter equal to or less than 5 cm), AND have not received any prior treatment for this. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. - Patients in Group 1 will receive radiation therapy using a technique called Stereotactic Ablative Body Radiotherapy (SABR) that will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 2 weeks. The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer. - Patients in Group 2 will receive standard of care treatment (SOC) as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist. The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE). This may require an anaesthetic and an overnight admission to the hospital. Regular follow-up visits will be scheduled at 4 weeks post-treatment and then 3 monthly intervals for 2 years and then 6 monthly until completion of the trial. The same procedures will be repeated but also include imaging; CT or MRI of the liver, blood tests, clinical assessments and a questionnaire on the patient's health status (collected 6 monthly until completion of the trial).

People in high-risk occupations, such as those in emergency service organizations, are at high risk of psychological disorders. Posttraumatic stress disorder (PTSD) is the most common psychiatric disorder that develops following exposure to a traumatic event, and emergency service personnel have markedly higher rates of PTSD. PTSD is characterised by severe and persistent stress reactions including: intrusive memories and nightmares of the trauma, hypervigilance, difficulty sleeping, emotional withdrawal, pervasive negative emotions, and avoidance of places, activities, and situations that are reminiscent of their trauma. The treatment of choice for posttraumatic stress disorder (PTSD) is trauma-focused psychotherapy. Trauma-focused psychotherapy typically commences with psychoeducation about the trauma responses, and then focuses on three major strategies: anxiety management, exposure, and cognitive restructuring. Despite support for this therapeutic approach, meta-analyses indicate that at least one-third of patients do not respond to this treatment. This situation is also evidence in treatment of PTSD in emergency service personnel. One recent advance has shown that training people to retrieve positive memories of their past can alleviate both PTSD and depression symptoms. Accordingly, this trial aims to augment TF-CBT for PTSD by comparing standard TF-CBT with TF-CBT combined with memory training. It is hypothesized that the augmented TF-CBT that includes positive memory training will result in greater reduction of PTSD and depression than standard TF-CBT.

Irritable Bowel Syndrome is part of a range of disorders classified as a “Functional Gastrointestinal Disorders”. IBS is referred to as a FGID, as the person experiences uncomfortable and often intrusive symptoms; however, on medical investigation (either endoscopy, colonoscopy or other non invasive tests), no medical abnormalities are found. As a result, the issue is regarded as being to do with the functioning of the gut or the gut-brain interaction, rather than organic disease. This condition may cause intestinal microflora imbalance, and in the long term may lead to constipation, diarrhea, gastroenteritis, gastric ulcer, and other gastrointestinal diseases. Post antibiotic treatment tend to affect the diversity of intestinal microflora, causing diarrhea, flatulence, and nausea. This project aims to observe the effectiveness of deactivated Bacillus subtilis strain BG01-4™ consumption by patients in relieving the gastrointestinal symptoms and restoring their intestinal microflora.

Participants were randomised into one of three groups with different levels of fibre. This trial is a feasibility study that aimed to assess the acceptability of additional fibre in the daily diet (through BARLEYmax). This is in order to inform a larger randomised controlled trial that aims to explore the effect of increasing fibre intake on body composition and weight loss. We hypothesised that BARLEYmax would be a safe, well accepted supplement, that would increase satiety.

The prevalence of cancer diagnosis is high and attributable to 30% of all deaths in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. This pilot intervention study aims to assess the treatment effect and safety of Light-bed-PDT for patients with cancer using Circulating Tumour Cell (CTC) analyses. Who is it for? You may be eligible for this study, if you have been diagnosed with cancer. Study details Cancer patients will undergo 2 sessions of Light-bed Photodynamic Therapy (PDT) on 2 consecutive days. 1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light 15-20 hours before 2. LED Light-Bed whole body therapy, which involves lying in a red-light-bed for 30 min. These treatments will be provided to participants 2 times on two consecutive days. A blood test measuring the number of Circulating Tumour Cells (CTC) before and 3 weeks after treatment will assess treatment effectiveness. Fluorescence photography of the ear lobe will also be performed before and after treatment. Tolerability and safety will be assessed after each treatment session. This study will provide insight into the safety and efficacy of Light-bed Photodynamic Therapy (PDT) in cancer patients.

We propose to assess the safety and effectiveness of esophageal dilation at the time of food bolus disimpaction in reducing the risk of recurrent FBO in a retrospective analysis of a prospective database from 2008 to 2017. We aim to compare patients who undergo concurrent esophageal dilation using Savary Gillard dilator catheters at the time of food bolus disimpaction and those who have elective esophageal dilation as an outpatient. We expect that the concurrent esophageal dilation at the time of initial removal of food bolus is safe and effective in reducing the risk of recurrent FBO given it will treat the underlying pathology and stretch the esophagus. As a consequence, the patient does not need to return to hospital for a second endoscopy or represent to hospital with recurrent FBO. This would not only reduce health care cost but also reduce the number of patients presenting to emergency department with recurrent FBO.

The purpose of this study is to look at the safety, tolerability and effectiveness of the combination of three drugs cetuximab, cobimetinib and palbociclib in patients with advanced or metastatic colorectal cancer with certain mutations, who have not responded to standard therapies. Who is it for? You may be eligible to join this study if you are aged 18 years and above, and have been diagnosed with advanced or metastatic colorectal cancer which has tumour expression of BRAF or KRAS mutations, and you have not responded to available standard therapies. Study details All participants in this study will receive cetuximab, cobimetinib and palbociclib. This study will have 2 stages: Phase 1 and Phase 2. In Phase 1, there will be up to 6 groups of participants. Each group receives different dosages of each drug. Cetuximab will be given intravenously once a week, while cobimetinib and palbociclib will be given orally once a day for 21 consecutive days for at least two 28-day cycles. In Phase 2, all participants will receive the same dose of cetuximab, cobimetinib and palbociclib; with the dose being determined by results from Phase 1. Cetuximab will be given intravenously once a week, while cobimetinib and palbociclib will be given orally once a day for 21 consecutive days for at least two 28-day cycles. Participants will be monitored for side effects, disease response and survival. Blood tests, physical exams, eye exams, electrocardiograms and CT scans may be performed at various timepoints including pre-treatment screening and Days 1, 4, 8, 15 and 22 of each 28-day cycle. It is hoped this trial will provide information on the safety and effectiveness of the proposed combination drug therapy in treating advanced or metastatic colorectal cancer, and be an option for patients who have not responded to current therapies.

This study seeks to trial a community pharmacist-led physical health monitoring program for mental health consumers taking at least one second generation antipsychotic medication on a regular basis. Participants will be required to attend a total of five consultations with the pharmacist (initial session and then every 3 months thereafter for 12 months). The sessions will involve assessment of medical history, lifestyle factors and measurement of blood glucose and cholesterol level involving finger prick tests. Blood pressure, height, weight, waist circumference and calculated body mass index will also be measured. Screening for obstructive sleep apnoea using a questionnaire will be conducted at the first appointment only. Each consultation may take approximately 45 to 60 minutes. The length of the consultation will depend on the findings from the assessment. Only one cohort will be recruited. Although community pharmacists have previously provided programs in-store to help support mental health consumers, there are insufficient published data on pharmacists providing metabolic monitoring for mental health consumers on medications with high risk of metabolic syndrome. This study is expected to explore the feasibility of community pharmacists in conducting physical health monitoring (that includes metabolic monitoring) in store and explore whether intervention was able to result in any detectable change. We expect our data to at least reveal that the program is feasible in a community pharmacy environment and that consumers find the service accessible and convenient. We also expect that responses will indicate that mental health consumers feel supported in the management of known side effects of second generation anti-psychotic use (e.g. weight gain) and any trend towards differences in metabolic responses to the initial baseline findings. Findings from each session will be discussed with the consumer by the pharmacist and advice (including diet or lifestyle) will be provided where necessary. Should it be required, referrals will be made to participant's regular doctor will be made and the pharmacist will communicate the findings with participant's regular doctor and arrange for a follow-up appointment.