ANZCTR search results

Brief description of the study purpose The CAPITALL Study aims to determine whether introducing blinatumomab earlier in the treatment of children and adolescents with B-cell acute lymphoblastic leukaemia (B-ALL) can achieve similar levels of leukaemia clearance and cure, while potentially reducing the overall treatment burden compared with the standard chemotherapy regime. Who is it for? You may be eligible for this study if you are under 18 years of age who are newly diagnosed with B-cell acute lymphoblastic leukaemia (B-ALL), including certain infant cases without KMT2A rearrangement. Study details All those who are eligible will be treated according to their risk group (standard, medium, or high risk) using established clinical, genetic, and molecular criteria. Most participants (excluding standard-risk patients) will receive blinatumomab following initial induction therapy. Blinatumomab is an approved medication given as a continuous intravenous infusion over 28 days, with 1–3 treatment blocks depending on the participant’s treatment plan. This is a single-arm study, meaning all participants receive study treatment, and there is no randomisation. Study results will be compared to historical patient data from previous trials and standard treatment regimens. Participants will undergo regular assessments, including blood tests and molecular testing (e.g. minimal residual disease testing), to measure how effectively the treatment clears leukaemia cells. It is hoped that the results from this study will help demonstrate whether earlier use of blinatumomab can maintain treatment effectiveness while reducing treatment intensity, potentially improving outcomes and quality of life for children with B-ALL.

1. This study is a clinical trial in healthy adults to understand how safe SLTE-1009 is and how the body handles it. 2. SLTE-1009 is an investigational medicine that affects certain brain pathways and is being developed for possible use in Migraine patients. 3. Participants will receive either a single Intravenous dose or multiple subcutaneous doses of the study drug or a placebo, with careful monitoring throughout the study. 4. Doctors will closely monitor participants for side effects, 5. The study uses small groups, step-by-step dosing, and close medical supervision to help ensure participant safety.

This study will look at the Feasibility of delivering Physiotherapy and Dietetics intervention via a hybrid format (online and face to face) for patients with end stage knee osteoarthritis referred to a public hospital for surgical opinion. The study will focus on patients with a Body Mass Index >35kg/m2. We think it is feasible to deliver this intervention in a hybrid format for this patient group. The secondary aim is to determine if this combined treatment is effective in this format. We will look at weight loss and functional improvement to determine this.

De-escalation skills are highly regarded by staff and patients as a tactical approach to Occupational Violence (OV) prevention and response. De-escalation refers to a range of communication techniques (non-verbal and verbal communication) to help a person (e.g. patients, consumers) regain control of their emotions (e.g. agitation, distress, frustration, anger) and assist them to calm reducing the likelihood and severity of OV by defusing emotions before they escalate to aggression or violence. This study we will evaluate a VR-based de-escalation training of Emergency Department staff.

Mother–Infant Dialectical Behaviour Therapy (MIDBT) is a specialist group programme that supports mothers with borderline personality disorder to develop skills for managing emotions and cope with the challenges of parenting. Although the programme has shown significant benefits, many mothers are unable to attend face-to-face groups because of geographical location, limited transport options or other practical barriers. This study aims to evaluate a telehealth version of the MIDBT programme and compare it with the existing face-to-face programme and a wait-list control group. The study will assess whether telehealth MIDBT improves borderline personality symptoms, depression, anxiety, post-traumatic disorder symptoms, parental stress, child social-emotional functioning and health-related quality of life. It will also explore how acceptable and practical the telehealth programme is and gather participants’ views and experiences. We predict that telehealth MIDBT will lead to greater improvements in mental health, parental stress and child social-emotional functioning compared with the wait-list group, while also being acceptable. We also expect that outcomes for telehealth MIDBT will be comparable to those achieved with the existing face-to-face MIDBT programme.

This online randomised controlled trial aims to investigate the effects of advice framing and delivery mode on participants’ intentions to use opioids for acute low back pain. Adults with current or recent (within the past three months) non-specific low back pain who have not sought medical care for this condition in the past year will complete online baseline questionnaires then be randomised to one of four intervention groups in a 2×2 factorial design: 1. Opioids “not recommended/should be avoided” + Clinician-delivered advice (n=784) 2. Opioids as a “last resort” + Clinician-delivered advice (n=784) 3. Opioids “not recommended/should be avoided” + AI-delivered advice (n=784) 4. Opioids as a “last resort” + AI-delivered advice (n=784) Participants in all groups will be given the same hypothetical case of acute low back pain and view a short intervention video corresponding to their allocated group. They will then complete a post-intervention questionnaire including questions on intention to use opioids, treatment credibility, satisfaction, and behavioural intentions. The trial will be conducted entirely online using REDCap.

This Phase 1 trial is designed to assess the safety, reactogenicity, and immunogenicity of a single IM booster dose of PVX-001 across three ascending dose levels in previously vaccinated healthy adults, in a controlled clinical setting with staged sentinel dosing and an independent Safety Review Committee. This study will be conducted in healthy women aged 18 to 64 years and healthy men aged 30 to 64 years of age.

The Chronic Conditions Course for Young Adults (CCC-YA) is an internet-delivered psychological program adapted specifically for young adults aged 18 to 29 who are living with a chronic physical health condition. This course is a modified version of the Chronic Conditions Course, and is based on cognitive behaviour therapy (CBT) principles. It is designed to help young adults understand and manage symptoms and the impacts of their condition on daily functioning and emotional wellbeing. The course includes 5 lessons, delivered over 8 weeks. The lessons are all delivered via the internet, and provide information and skills for improving emotional wellbeing and daily functioning. Participants have the option of support from a psychologist throughout the course. The primary aim is to evaluate the efficacy of this online psychological program in improving symptoms of anxiety, depression, and disability when specifically adapted for young adults with chronic health conditions. We hypothesise that the program will result in significant improvements in anxiety, depression, and disability at the completion of treatment.

Brief description of the study purpose This study aims to investigate whether self-guided use of sensory massage balls is a feasible, safe and effective way to reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as numbness, tingling, pain and weakness, and to improve quality of life for people affected by CIPN. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older who are receiving chemotherapy or have completed chemotherapy within the previous month, are receiving care through Tweed Valley Hospital, and have symptoms consistent with chemotherapy-induced peripheral neuropathy. Study details Eligible participants will be randomly assigned to one of two groups. One group will receive a set of sensory massage balls and instructions for daily self-guided use at home for 8 weeks, while the other group will receive usual care in the form of publicly available physical activity guidance. After completing Week 8 assessments, participants in the usual care group will also receive the massage ball set if no intervention-related safety concerns are identified. Participants will attend study assessments at baseline, Week 8 and Week 16. During the intervention period, participants using the massage balls will record their usage and symptoms in a daily logbook and receive an initial face-to-face training session. Study assessments will evaluate neuropathy severity, quality of life, balance, strength and hand dexterity. It is hoped that the results of this pilot study will inform larger future clinical trials and contribute to the development of supportive care strategies for people experiencing chemotherapy-induced peripheral neuropathy.

Hip pain is common and can make it difficult for people to participate in physical activity and everyday activities. This study aims to determine whether a 12-week physiotherapist-led graded activity modification program is feasible for adults with hip-related pain. Participants will complete two face-to-face clinical assessments and participate in five individual physiotherapy consultations delivered via telehealth. The program will gradually modify and progress physical activity based on each participant's symptoms and goals. Throughout the study, participants will complete online questionnaires and provide information about their symptoms, physical activity, and study experience. The findings will determine whether a larger randomised controlled trial should be undertaken to evaluate the effectiveness of this intervention for people with hip-related pain.