ANZCTR search results

This study is investigating whether aiming to restore a healthy microbiota, gut barrier and digestion through faecal microbiota transplantation (FMT) alongside chemotherapy can effectively treat and relieve symptoms and pain in non-resectable pancreatic cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 75 years of age, and have been diagnosed with non-resectable pancreatic cancer (i.e. pancreatic tumours that cannot be removed through surgery). Study details Participants will be randomly assigned to either receive FMT or placebo capsules in 2 separate treatment periods: one before chemotherapy and one 4 weeks after chemotherapy cessation. All participants will receive Folfirinox chemotherapy for either 3 or 6 months depending on the treating oncologist's review of their clinical response at 3 months. Safety, tolerability and efficacy data will be collected from participants over the course of their participation in this study. This study represents a unique opportunity to provide a novel and promising intervention for the management of pancreatic cancer and its symptoms to Australian patients to improve their health outcomes.

This study is determining if a novel co-designed therapeutic exercise program is feasible, acceptable, and potentially effective for survivors of paediatric sarcoma. Who is it for? You may be eligible for this study if you are aged between 8 - 18 years of age, diagnosed with sarcoma that required surgical resection at least 12 months earlier, but no more than 5 years prior to enrolment, not undergoing any cancer treatment, and medically able to complete the exercise program. Study details Participants will receive weekly face-to-face individualised goal-directed exercise program for 12 weeks, delivered by a physiotherapist or exercise physiologist. There will also be an accompanying home-based program three times per week. Treatment completion will be checked. Assessments of participant fitness, everyday functioning and activity levels will be at the beginning and end of the program (12-weeks), and at 6 months follow up. Test will include VO2 peak, six minute walk test, timed up and go, timed up and down stairs and pTESS] If the exercise program is shown to be feasible, acceptable, and efficacious, the program has strong potential for testing in larger studies involving more research centres and subsequent use in routine clinical practice. The study will be the first to explore the feasibility, acceptability and efficacy of therapeutic exercise to improve fitness, physical function and physical activity in survivors of childhood sarcoma; improvements in these outcomes could dramatically improve the quality of survivorship and play a major role in mitigating the significant risk of disabling secondary health conditions later in life

The purpose of this study is to examine the efficacy, feasibility, and acceptability of videoconferencing-delivered CBT for anxiety disorders in LGBTQ+ adults. A CONSORT-R compliant, two-group, randomised control feasibility trial (RCT) will examine the research questions. The hypotheses for this study are below: 1) Videoconferencing-delivered, standard CBT will result in significant reductions in symptoms with a large between-group and within-group effect size at post-treatment and three-month follow-up. 2) Videoconferencing-delivered, LGBTQ-adapted CBT will result in a similar degree of symptom reduction when compared to standard CBT. 3) Videoconferencing-delivered standard CBT and LGBTQ-adapted CBT will be feasible to deliver to LGBTQ+ adults with diagnosed anxiety 4) Videoconferencing-delivered CBT will be acceptable to LGBTQ+ adults with diagnosed anxiety disorders

Chronic Kidney Disease (CKD) Stewardship aims to identify people with mid to late stage CKD, who are admitted to hospital for any reason, to improve the proportion of patients receiving optimal guideline directed management. Patients will be enrolled from 6 different public hospitals in NSW over a period of 12 months and half will receive the CKD Stewardship intervention and half will receive usual care. This study seeks to compare the proportion of patients referred to a nephrologist, receiving appropriate medications and receiving regular kidney health testing at 12 months in the intervention group compared with the usual care group.

The purpose of this study is to detect ptDNA using two different methods, and to determine if ptDNA can be used to provide information on the patient's cancer and chances of survival. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer of the gastroesophageal junction, the area where the esophagus and stomach join together. Study details We will recruit at least 200 patients with stomach and oesophageal cancer, and test their peritoneal washings, collected as part of routine staging, for ptDNA. We will also follow up all patients for 5 years after they are enrolled by collecting any relevant data from their medical records, specifically information on their cancer, possible cancer recurrence and survival. It is hoped that this study will produce a novel and accurate molecular test to detect microscopic peritoneal cancer deposits. This information will improve disease prognostication, facilitate patient counselling, inform clinical decision-making, and personalise cancer treatment to maximise benefit and reduce harm. If successful, this study will produce a novel and accurate molecular test to detect microscopic peritoneal cancer deposits. This information will improve disease prognostication, facilitate patient counselling, inform clinical decision-making, and personalise cancer treatment to maximise benefit and reduce harm.

The Public Health Palliative Care Unit at La Trobe University is piloting the Healthy End of Life Planning (HELP) Brief Intervention (BI), which introduces network-centred care (NCC) using a digital platform, the HELP App, to enable palliative care organisations and services to leverage community assets and capacity and increase societal participation to support their clients and their carers and improve their end-of-life care experiences (La Trobe University, 2023). The HELP BI seeks palliative care service providers to introduce the HELP App to their clients and their carers to ask for and accept help from their informal care networks in the community. This study aims to generate evidence on the effectiveness of NCC through the utilisation of HELP BI in improving the palliative care outcomes of the clients and their carers and to assess the implementation process of the HELP BI from the perspective of the implementers to facilitate future implementation on a larger scale. The specific objectives of this study are to determine whether the NCC, through the utilisation of the HELP App, facilitates dying at the preferred site of death and reducing hospital admissions, carer’s stress, and carers’ bereavement risk, as well as to explore the barriers and facilitators to implementing HELP BI by palliative care services into the community.

This study is assessing the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years old, and you suffer from anxiety after adjusting to an acutely stressful event of your cancer diagnosis. We call that an adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg PEX010 dose group, a 10 mg PEX010 dose group or a 1mg PEX010 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with PEX010 administered at Day 14 (dosing day). At Week 12, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg PEX010). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3- and 6-months post Week 12 (of the final cycle) to assess safety and tolerability of PEX010. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

This study aims to evaluate glucose control and safety with a sodium-glucose linked transporter in people living with type 1 diabetes. It will involve the use of continuous glucose monitoring and ketone sensing devices combined with education aimed at minimising the risk of diabetic ketoacidosis. The study will take place over seven months, comprising of two weeks of run-in, three months of intervention with dapagliflozin or placebo, followed by cross-over separated by a two week wash-out. Outcomes regarding glycaemia, ketones, anthropometric, cardio-renal, metabolic and psychological parameters will be assessed. We hypothesize that glucose control will improve without a significant increase in diabetes ketoacidosis occurrences in people with type 1 diabetes on dapagliflozin compared to placebo, with the use of continuous interstitial ketone monitoring in conjunction with education regarding management.

Physical activity is integral during rehabilitation for restoring physical function and independence. In recent years, wearable activity trackers (such as Fitbits) have emerged as a potential solution for tracking and encouraging physical activity outside of face-to-face therapy. However, standardised protocols for their use in hospital settings are lacking. This project aims to evaluate the feasibility of using wearable activity trackers to promote patient activity during an admission to a virtual rehabilitation ward or an outpatient rehabilitation program. This single-group feasibility study will address the following research questions: 1) Is the protocol for using wearable activity trackers to monitor and promote patient physical activity feasible? 2) What factors do or don’t support uptake, engagement, and acceptability of wearable activity trackers into rehabilitation?

The primary aim of this feasibility study is to assess the feasibility of a type of progressive resistance strength exercises for early onset Parkinson's disease, Modified Powerlifting will be conducted at a community gym for people with early onset PD. Adults under the age of 50 years who have a diagnosis of Parkinson's disease will be eligible to participate in an 8-week program, twice per week for up to 1 hour per session. We will measure the feasibility, including safety and adherence, as well as individual changes in disability, quality of life and strength over the course of the program.