ANZCTR search results

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

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44 results sorted by trial registration date.
  • Testing the MySurvivorCare website: An online tool to help breast cancer survivors manage hot flushes and night sweats after cancer

    In Australia, many cancer survivors live with bothersome vasomotor symptoms (i.e., hot flushes and night sweats) after cancer treatment. These symptoms can affect daily life. Although supportive treatments exist, barriers such as geographical location, limited specialist clinics hinder accessibility. To address this, efficient models of care to improve access to existing healthcare services are necessary. The MySurvivorCare website, an online health tool designed to help cancer survivors manage hot flushes and night sweats after cancer, was developed to address the unmet. Why this study? This study aims to find out whether it is feasible to conduct a large trial of the MySurvivorCare website before it is launched or made publicly available. Who is it for? You may be eligible for this study if you are a breast cancer survivor and are experiencing hot flushes/night sweats. Study details Participants in this study will be, by chance, allocated to use either the MySurvivorCare website or be provided with access to menopause information from the Australasian Menopause Society website. The MySurvivorCare website will provide users with a self-help guide and information to provide to your GP regarding how to manage symptoms according to the current best practice guidelines. The Australasian Menopause Society website provides educational resources on menopause, including how best to manage symptoms. Participants will be followed up for 6 months via questionnaires. It is hoped that this study will assess how acceptable and easy to use the MySurvivorCare website is, and whether it shows early signs of helping women manage their symptoms over time.

  • ASPiRATION-2 Liquid: An observational cohort study to assess the impact of longitudinal molecular profiling using circulating tumour DNA (ctDNA) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) after failure of genomically targeted therapy.

    The purpose of this study is to see if the approach of using a blood test called a ‘liquid biopsy’ multiple times throughout the patient journey can improve the management of lung cancer by successfully guiding treatment. We will assess if it is possible to incorporate liquid biopsy into the routine care of Australians with lung cancer, including evaluating the clinical benefits to patients and the economic impact to the health system. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced non-small cell lung cancer and you have received at least one previous targeted cancer treatment. Additional health checks may also be conducted by the study doctors to ensure you are able to take part in this study. Study details: All participants who choose to enroll in this study will be asked to provide a blood sample for molecular testing (liquid biopsy). The liquid biopsy test analyses fragments of DNA released from a person's cancer into their blood, known as circulating tumour DNA (ctDNA). This helps doctors to understand how a person's cancer has changed over time. The liquid biopsy results will be reviewed be reviewed by a board of experts. They will make treatment recommendations based on the liquid biopsy results. These will be provided to the participant's treating doctor, for discussion with the participant. Decisions for treatment are made by the participant and their treating doctor. Options may include a clinical research study, treatment(s) available through special access programs, and/or standard of care treatment that is routinely available. Participants will be asked to provide blood samples multiple times over a period of up to 4 years, including at study entry, each time a new treatment is started, and each time a treatment stops working. If a previous tissue sample is available or will be taken, e.g. during surgery, this may also be tested for new changes. Participants will also be asked to complete questionnaires throughout the study for up to 4 years after they enroll. It is hoped this research will determine whether adding liquid biopsy into the routine care of Australians with lung cancer is achievable, the economic costs and value of adding this procedure and to identify possible benefits to individuals with lung cancer by finding new targeted treatments for them.

  • Lung cancer rehabilitation and immunotherapy: a pilot randomised controlled trial.

    This study will evaluate the safety, feasibility and acceptability of a rehabilitation program (exercise and education) for people with lung cancer on immunotherapy. Who is it for? You may be eligible to join this study if you are a person aged 18 and above, have a histologically confirmed diagnosis of stage 4 lung cancer and are scheduled for or have commenced immunotherapy treatment at Peter MacCallum Cancer Centre (Melbourne). Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive usual care at their treating hospital which does not routinely involve referral to rehabilitation services. Participants in the other group will receive a 12-week rehabilitation program of exercise and education delivered by a physiotherapist. The first session is conducted face-to-face or online (using Zoom) to set up your exercise program and help you set goals. After this you will be able to attend twice-weekly group exercise classes for 12 weeks (conducted remotely by telehealth or at the hospital gym). The findings from this research will establish how feasible and acceptable it is to provide this rehabilitation service to those with lung cancer and support future research in the area.

  • Prehabilitation Closer to Home Study: Novel Evaluation of a Co-designed Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplantation.

    This study aims to enhance the efficacy and acceptability of a Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplant at The Peter MacCallum Cancer Centre (Peter Mac). The Prehabilitation Exercise service has been established at the Peter Mac for several years. Our research team engaged in a co-design process with former patients and Peter Mac staff to identify priority areas for improvement and design solutions. This research study will implement the co-designed solutions, evaluate them and make additional improvements where necessary. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have been diagnosed with a Haematological Cancer and are awaiting Bone Marrow Transplant at The Peter MacCallum Cancer Centre, and have been referred to the prehabilitation program. Study details All participants will have access to the prehabilitation exercise service as part of standard care. This includes access to an individualised exercise program and supervised exercise sessions delivered either face-to-face or via telehealth. Improvements developed as part of co-design include staff training modules focused on delivering trauma-informed exercise support and delivering engaging online exercise classes, additional printed resources for patients to support uptake of exercise, support for staff to better utilise exisiting exercise prescription software (simple set), and an online education hub. This study will be implemented in two stages: Package 1 will include standard care plus all of the co-designed components, except for the online education hub, while Package 2 will include standard care plus all co-designed components and the online education hub. Package 2 will be implemented 9-12 months after the study commences, after Package 1 completion. Participants will be followed-up within two weeks prior to their bone marrow transplant to assess efficacy and acceptability of each package. The majority of the assessments completed (e.g., 6 minute walk test) are completed as part of standard care. Study specific assessments include questionnaires on intervention acceptability. It is hoped that this research project will lead to an optimised prehabilitation model of care at the Peter Mac, and pave the way for trialling the optimised model of care across multiple health services.

  • A study to test the acceptability, feasibility and potential efficacy of the SAMSON solution for medication adherence in cancer

    This trial will assess the acceptability, feasibility and potential efficacy of the SAMSON digital platform, which is designed to support patients who are taking oral cancer medications by targeting their medication adherence to the treatment and medication errors. Who is it for? You may be eligible for this study if you are aged 18 years or over and have received a confirmed diagnosis of any-stage haematological, lung or melanoma cancer, for which you are scheduled to commence oral anti-cancer treatment as part of routine care or commencing treatment/currently treated with the medication for less than 12 months. Study details Participants will be randomly assigned to either the SAMSON intervention group or a standard-of-care group over the 12-week study period. Those in the intervention group will receive access to the SAMSON apps which record medication adherence and side effects, as well as structured counselling sessions with healthcare professionals at the beginning for the study and weeks 1, 4, 8 and 12. Those in the standard-of-care group will receive usual care, including a clinician consultation, initial pharmacist consultation and be followed-up by a nurse for medication side effects. Participants will be asked to complete surveys over the course of the study. It is hoped that this research will help provide an effective way of managing medications during cancer treatment.

  • A comparison of online and face-to-face Dialectical Behaviour Therapy: A parallel group randomized trial and pragmatic evaluation

    DBT is a programme that has traditionally been delivered face-to-face. That is, people meet face-to-face with a therapist, and attend a skills training group face-to-face for the duration of the programme. People sometimes contact their therapist for coaching by phone. Recently it has become common to offer both individual therapy and skills training online. Our group and other researchers have been exploring the best ways to deliver DBT online to make this very effective programme available to more people. The Australian DBT Institute developed an online DBT programme over five years ago. We have interviewed therapists about their experiences, and most said that online DBT is effective, safe, and most people like it. Some people prefer it to face-to-face DBT. We wish to compare the effectiveness and experience of a full DBT programme delivered face-to-face and online. There has been no research published that has done this.

  • Care Plus Study: A multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer.

    This study aims to integrate early palliative care known as Care Plus in routine practice for patients with advanced cancers. Who is it for? Adults with a targeted advanced cancer who present to one of the study's hospital sites (St Vincent's Hospital Melbourne, Peter MacCallum Cancer Centre and Lyell McEwin Hospital), and who have reached a certain point in their illness will receive Care Plus as part of the hospital's new practice change. Study Details Six months prior to introducing Care Plus at each hospital site, patients with targeted advanced cancers who reach a key point in their illness will receive usual oncological care (Control group). This involves the treating clinician making referral to palliative care at their discretion. During the practice change period, in which Care Plus is introduced, all patients with targeted advanced cancers reaching a key point in their illness will, by default, receive usual oncological care by their treating clinician AND Care Plus as part of the hospital's new practice change. This involves a scheduled palliative care consultation and ongoing follow-up visits with specialists and nurse specialists. During these consultations, patients and their caregivers will have the opportunity to discuss pain and nausea management, and any other physiological, psychological, practical, social and spiritual needs. It is hoped this research will contribute to reduced hospitalisations for cancer patients, improved quality of life and improved efficiency for the healthcare system.

  • Stem cell transplant influenza vaccination strategies

    This study will compare the level of protection afforded by two different influenza vaccination strategies in patients who have undergone autologous haematopoietic stem cell transplantation. Who is it for? You may be eligible to join this study if you are aged at least 18 years, have received an autologous haematopoietic stem cell transplantation (autoHSCT) within the last 12 months, and have not received an influenza vaccine for the 2019 season following your transplant. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a new two dose strategy, which consists of the trivalent high dose influenza vaccine followed by a second dose of quadrivalent standard dose influenza vaccine one month later. Participants in the other group will receive the current standard two dose strategy of quadrivalent influenza vaccine one month apart. All vaccines will be administered by injection into the muscle. All participants will be required to provide blood samples at four time points: 1) before first influenza vaccination, 2) before second influenza vaccination; 3) 21-28 days post-second-vaccination; and 4) approximately 6 months post-vaccination. They will also be asked to provide information on vaccination history, side effects and occurrence of influenza-like illnesses (ILI). Participants who develop respiratory symptoms during the study period will be asked to provide a nasal swab. Findings may assist in improving vaccine responses and protection from influenza in a highly vulnerable patient group

  • The OBSERVE Cystic Fibrosis (CF) Study, to assess the effect of orkambi on people with CF in Australia

    Aim To determine the safety and efficacy of LUM/IVA in subjects >12 years of age with CF, homozygous for F508del mutation of CFTR and an FEV1<40% of predicted normal, by comparing those patients treated with LUM/IVA with a cohort of age and sex matched CF controls with another set of mutations that lead to severe CFTR dysfunction (belonging to Class I, II or III), with an FEV1<40%5.

  • Single centred, interventional study on abdominal breathing to eliminate/reduce sleep apnoea.

    The study is interventional, employing behavioural approaches and diagnostic procedures. The behavioural change aims to instil during the day (awake) and continue abdominal breathing by the participants during sleep. The study will include instructions, training and bringing abdominal muscle awareness to participants during breathing which will be mirrored with biofeedback. Secondly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The training on the interventions will be delivered by staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment. The mode of delivery will be face to face preferably in group sessions (individually if requested by participants), employing instructions, training, as well as remote monitoring via telephone and internet.

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