ANZCTR search results

The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a multimodal early supportive care program delivered during neoadjuvant chemotherapy treatment for women with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned to receive neoadjuvant (i.e. prior to surgery) chemotherapy. Study details All participants will receive the supportive care program for the duration of their chemotherapy treatment. The program will involve an holistic nursing assessment, tailored exercise (3x per week), three education modules and complementary therapies (acupuncture, massage etc) prescribed and provided when symptom burden is moderate to severe. Participants will complete a number of questionnaires, tests of physical function, and blood tests at the time of enrolment, mid-program, upon completion of the program, after completion of surgery, and at 6 months post-enrolment, in order to determine the safety, acceptability, and effectiveness of the program. It is hoped that this study may show that the multimodal early supportive care program is safe, acceptable to patients and their treating clinicians, and effective in modifying side effects of treatment, chemotherapy adherence, anthropometric measures, and selected cardiac, and disease recurrence risk factors, self-efficacy and satisfaction with surgery.

Functional defecation disorders are the underlying causes of one third of all constipation and half of all fecal incontinence. Anorectal biofeedback therapy is a safe and effective form of rehabilitation therapy that uses anorectal muscle exercises to restore normal bowel function. However, due to access and cost issues biofeedback therapy is not accessible to most patients. This randomized controlled trial involves an experimental internet-of-medical-things device that will aid in biofeedback therapy and allow for training to be conducted at a patient's home. We aim to compare therapy delivered using the experimental device against conventional clinic-based anorectal biofeedback therapy.

This is an investigational agent within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. This investigational agent (SNDX5613- a new treatment) will be evaluated for its activity alone in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details SNDX5613 is given orally by itself twice daily on an empty stomach at least 2hrs after a meal or 1 hour before the next meal. Administered days 1-28 of a 28 day cycle for 12 cycles. Patients with minimal residual disease will have a pilot safety run-in phase to confirm dose - investigating doses 276mg twice daily, 226mg twice daily and 163mg twice daily. Once a tolerable dose is determined that dose will be used in a proof of concept phase.. Patients with morphologic relapse will enter directly into a proof of concept phase using 276mg twice daily dose. Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. 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 SNDX5613 will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Tobacco remains Australia’s single most preventable cause of death. While plain packaging with larger graphic health warnings and tobacco excise increases have recently reduced smoking prevalence, further progress is endangered by the tobacco industry’s rapid evolution of reassurance marketing. This marketing promotes particular product attributes, brand variants or sensory experiences that mislead smokers into believing these products offer reduced harm; in fact, they offer only the illusion of protection. Examples include an explosion of suggestive brand variant names and descriptors (e.g. ‘smooth’ taste, ‘quality’ descriptors) on packs, and vigorous promotion of mentholated products, filters that vary in appearance, filter-venting and ‘natural’ roll-your-own tobacco. Using principles of faulty belief correction, we aim to create a set of salient corrective warnings on packs that convey how specific product attributes (Product Attribute Health Warnings) do not reduce the likelihood of disease. This study aims to investigate the effectiveness of Product Attribute Health Warnings and an accompanying television advertisement on perceptions of enjoyment and concern when inhaling smoke with favourable sensory experiences as well as their impact on smoke limiting behaviours among Australian adults who smoke regularly. The four alternative warning label conditions to be tested via the online experiment include: two control groups (A) No Tobacco Health Warnings (consisting of warnings from over-the-counter medicine); and (B) New Standard Health Warnings (to represent the usual situation); and two groups exposed to systematically developed (C) Product Attribute Health Warnings; and (D) Product Attribute Health Warnings plus a TV advertisement. The findings from this study will contribute to the evidence base available for advocacy and forthcoming policy deliberations on tobacco health warning labels.

This study (called TELE-CONNECT) is a telehealth program to deliver pelvic floor muscle training to women with gynaecological cancer who suffer from urinary incontinence. Urinary incontinence affects around one-third of women causing signifcant physical, social, emotional and financial burden. The prevalence of incontinence is doubled in women with gynaecological cancer. Although evidence supports pelvic floor muscle training as first-line treatment for urinary incontinence, it is not known whether this treatment is as effective for women following gynaecological cancer treatment. This will be the first randomised trial to address this vital clinical question using the novel method of telehealth. Who is it for? You may be eligible for this study if you are an adult female following cancer treatment (with and without radiotherapy) for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour. Study details: Participants who consent to be contacted by the research team will receive a phone call to determine their eligibility. Those who are suitable for the study and consent to participate will complete a baseline assessment and record any bladder leakage experienced over a 7-day period using an ‘Accident Diary’. They will then be asked to participate in one of two different treatment groups 1) usual care or 2) pelvic floor physiotherapy delivered via video-calls. Each participant is put into a group by chance (randomly) using a computer program. Participants in both groups will be sent high quality bladder and bowel advice handouts. Group 1 will receive one, 15-minute telephone call with a female member of the research team. Group 2 will receive an intensive, supervised, 16-week telehealth-delivered pelvic floor muscle training program (including 8 video-consultations) from a female, qualified and experienced physiotherapist. They will also receive their own pelvic floor muscle biofeedback device. All participants will complete questionnaires at the end of 17 and 52 weeks from the commencement of the study. It is hoped that this research trial will demonstrate that a 16-week, physiotherapist-supervised, telehealth-delivered pelvic floor muscle training program can reduce urinary incontinence compared with usual care, in women following gynaecological cancer treatment.

Comparison of the Slider prong Continuous positive airway pressure (CPAP) interface to the standard Fisher and Paykel CPAP interface in terms of effectiveness for the management of neonatal respiratory distress syndrome, incidence of nasal trauma and acceptability to nursing staff and parents of babies with respiratory distress syndrome in the Mercy Womens Neonatal intensive care unit.

Prior research has found that couples continue after multiple unsuccessful cycles of IVF despite being aware of limited chances of success because they interpret their own chances of success in a positive light (Copp et al., 2020). In addition, many recall hearing anecdotal stories of friends or women at the same clinic having success after a large number of cycles. These anecdotal stories of success seem to play an influential role in fuelling hope and contribute to unrealistic expectations of IVF effectiveness. Whilst consumers scrutinise statistical information, narrative stories cause them to feel compelled (Jaramillo et al., 2019), illustrating the powerful influence of anecdotal stories. This study aims to explore - What is the influence of an anecdotal story of success against the odds despite contrasting statistical information on the low likelihood of success with another cycle of IVF - Does balancing anecdotes of success against anecdotes of failure attenuate their potential effects? Understanding the effect of anecdotal stories on medical decision making will help providers and consumers of IVF services be more aware of the impact anecdotal stories have. This could help patients make better-informed choices and encourage IVF providers to use anecdotes carefully and with caution.

Globally, stroke is a leading cause of death and disability. Despite the impact of stroke on public health, it is considered a lower priority for clinical services and research in many countries. This is possibly due to lack of readily available and accessible data on stroke care and outcomes to inform prevention strategies. Routinely collected coded administrative data are increasingly being used to generate evidence for the prevention and management of stroke. However, accurate clinical coding is critical to ensure these data are valuable and reliable. To ensure and maintain accurate coding, complete and representative clinical documentations are required. Therefore, this project is focused on implementing and evaluating educational interventions for clinicians and coders, in the form of online education on stroke and coding for stroke, to improve documentations and coding for stroke.

ACTMed is a new service designed to proactively find and address medicine problems before they cause harm. Participating pharmacists will use a specially designed software program (ACTionable Medication safety dashboard) that works within health IT systems to detect medicines problems. ACTMed works by bringing pharmacists, consumers and general practitioners together to deal with medicine problems. After the initial co-design/pilot phase, we will run a staged trial across at least 38 health services (Aboriginal Community Controlled Health Organizations (ACCHOs) and general practitioner practices) in Queensland and Victoria to assess how effective it is and whether it is good value for money.

Speech sound disorders are one of the most common types of communication disorder in young children. Children with speech sound disorders often have consistent error patterns such as substituting one sound (e.g. ‘k’) for a different sound (e.g. ‘t’). One common error pattern is deleting the weak or unstressed syllable in a word (e.g. saying ‘mato’ instead of ‘tomato’). Children who persist with these types of errors in their speech have an increased risk of literacy difficulties during the school years, so it is important that these speech errors are addressed. Currently, there are no evidence-based interventions for speech sound errors where children delete syllables in words. In this small scale research study, we want to find out if a commonly used speech pathology therapy known as, ‘minimal pairs therapy’, can help children to say long words more easily. Currently, minimal pairs therapy involves asking children to listen to and say words that only differ by one sound (i.e., hear and say pairs of words with minimal differences between them, such as ‘tea’ and ‘key’). This therapy approach has been used for short words and to correct specific consonants in error, since 1981. For example, if a child never uses ‘k’ in words and substitutes all ‘k’’ sounds with ‘t’ sounds, a speech pathologist might show a child a picture of a ‘key’ and a cup of ‘tea’. The speech pathologist would ask the child to practice naming the pictures using child friendly games and activities, and help them by modelling the words or giving specific prompts describing how to say the target sound in the word. While there is evidence suggesting minimal pairs therapy technique works for short words, it is yet to be tested with long words. We have proposed four research questions: In children with phonological impairment (a common type of speech sound disorder), does minimal pairs therapy targeting weak syllable deletion result in a reduction in weak syllable deletion in: 1. trained words with word-initial weak syllables? 2. untrained words with word-initial weak syllables? 3. untrained words with word-internal weak syllables? 4. a five-minute story retell task?