ANZCTR search results

Telehealth has become part of routine pregnancy care largely due to circumstance – the onset of the COVID-19 pandemic, and the associated public health advice,1 led most maternity providers in Victoria and elsewhere to commence providing some pregnancy care as telephone and/or video health. Emerging evidence of safety is conflicting regarding clinical outcomes, and there is a lack of prospectively collected evidence of the benefit or potential harms associated with telehealth for routine pregnancy care. This study aims to carefully evaluate the use of telehealth for routine pregnancy care in a randomised controlled trial (RCT) and test the safety and efficacy, the cost implications, and explore women’s experiences. This RCT will test whether the practice of offering a minimum of one up to a maximum of five routine pregnancy care visits via video-based telehealth is no less safe (i.e., the outcomes are not worse) than the pre-pandemic ‘usual’ pregnancy care, which was all face-to-face, and to find out if having access to some telehealth in pregnancy improves women’s experiences and access to care.

Currently, Prolonged Exposure (PE) therapy is considered the gold-standard treatment for PTSD. Emerging evidence suggests that the Unified Protocol (UP) may offer an alternative treatment option. Research indicates that UP may work in a slightly different way than PE, prompting further exploration into which factors influence treatment outcomes. In this trial, participants will complete assessments to gather a holistic picture of their symptoms and PTSD presentation, after which they will be randomly allocated to either the Unified Protocol (UP) or Prolonged Exposure (PE) therapy which are delivered in a massed format. Ultimately, the goal of this research is to improve the matching of individuals to the PTSD treatment that will be most effective for them based on the factors uncovered in the assessments.

This observational study aims to investigate the influence of FUT2 secretor status on the genitourinary and gut microbiota, as well as on the incidence of genitourinary infections. The hypotheses tested are: 1) whether genitourinary and gut microbiota differs between secretors and non-secretors, and 2) whether FUT2 secretor status or specific microbial profiles are associated with genitourinary infections. The study will also examine the effects of lifestyle and behavioural exposures on the vaginal microbiota. The study findings will improve our understanding on the biological and external factors that shape the microbial communities in the genitourinary tract and gut, as well as the bacterial interactions associated with the development of genitourinary infections.

Paramedics are routinely exposed to traumatic and high stress situations, making them particularly vulnerable to mental health challenges, reduced job satisfaction, burnout and potential additional time off work. Brain imaging research now shows that excess empathy (“feeling with”) someone who is distressed or in pain can turn into “empathic distress” (personal distress). Whereas compassion (focusing on how to alleviate the other’s suffering) protects against empathic distress and is associated with feelings of warmth, concern, reward and affiliation. Compassion improves the wellbeing and resilience of the giver. Compassion training involves practices designed to transform empathy into compassion, strengthen compassion, emotional regulation, resilience and protect against burnout. This trial will test whether compassion training can improve compassion, resilience, overall mental health and reduce burnout for Ambulance Victoria paramedics.

This study will investigate a new technique, immediate lymphaticovenous anastomosis (ILA), to preserve lymphatic drainage and prevent the development of breast cancer–related lymphedema. Who is it for? You may be eligible for this study if you are a female diagnosed with breast cancer and require axillary lymph node dissection (ALND). Study details During ALND, a fluorescent dye will be used to map the lymphatic vessels, which will then be joined to adjacent veins under high magnification using supermicrosurgical techniques. Follow-up data on the incidence of post-operative breast cancer–related lymphedema and any other surgical complications will be collected up to 12 months post-operatively. It is hoped that findings from this study will help identify new methods to manage the incidence of breast cancer–related lymphedema in those undergoing axillary lymph node dissection.

Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This study aims to assess the validity, reliability and clinical utility of a culturally-adapted digital screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — translated into Pitjantjatjara, to detect risk of substance-related harm among Aboriginal Australians.

The LiveBetterSA trial has been designed to compare the effectiveness of artificial intelligence (AI) powered digital health coaching to traditional telephone-based health coaching in supporting healthy lifestyle changes. The study aims to evaluate whether the digital health coaching program is as effective as telephone-based health coaching on weight management at 6 months. Participants will be randomly assigned to receive either digital health coaching or telephone health coaching over six months. The study will also examine the effects of digital health coaching on secondary outcomes—including waist circumference, physical activity levels, dietary habits, sleep, and quality of life, compared to traditional telephone-based coaching. In addition, the study will assess key implementation outcomes including participant engagement and program acceptability. Finally, a health economic analysis will be conducted to assess whether the digital health coaching model offers a cost-effective alternative to traditional telephone coaching. This study represents the first large-scale evaluation of an AI-powered digital health coaching model for preventive health. If successful, it could offer a scalable, sustainable approach to improving population health in Australia.

The purpose of this study is to pilot test an automated STS intervention and collect data to support development of a future definitive trial of the hypothesis that patients with heart failure whose routine on-going care includes a nurse-led ASTS intervention will have greater knowledge and better adherence to evidence-based self-care behaviours for their heart failure, with consequently better outcomes (in terms of fewer hospitalisations for acute heart failure episodes, better health-related quality of life and longer survival post-diagnosis) than heart failure patients managed with routine care alone.

A substantial percentage of people with metastatic breast cancer (MBC) experience poor quality-of-life and elevated distress, yet few interventions address this. The few intervention studies that have been done have mainly focused on high intensity and high burden interventions, such as face-to-face therapies, without consideration of low intensity options, such as digital interventions. Beatty and colleagues were among the first to design an online self-directed intervention for people with MBC; Finding My Way-Advanced (FMW-A). However, the efficacy of low intensity digital interventions may be impacted by low engagement. The purpose of this study is to explore methods of increasing engagement in this population, with the addition of guidance appearing to be promising in digital mental health interventions. Who is it for? You may be eligible for this study if you are a woman aged 18+ who has been diagnosed with MBC. Study details Participants will be randomly allocated (i.e. allocated by chance) to one of three condition arms: email, phone-call and video-call guidance. Participants will receive a 6-module psychosocial program that addresses commonly experienced concerns raised by women with MBC. Each of the six modules focuses on a different topic, namely (1) Navigating healthcare and making decisions; (2) Living well with a progressing illness (managing fear of progression and coping with uncertainty); (3) Managing physical symptoms (particularly focusing on fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role changes; and (6) Social support: receiving support and supporting family. Module content is provided in multimedia format, with video and written personal accounts from women living with MBC, educational videos from health care professionals, self-management activities, audio relaxation-mindfulness files, print psychoeducation with audio-conversion options, and illustrations/imagery throughout. Participants in all 3 conditions will be assessed for feasibility and complete self-report measures of quality-of-life, psychological distress, cancer specific distress, fear of progression, self-efficacy and positive psychology outcomes at the baseline. They will then be asked to complete the same online questionnaire assessing quality of life, distress, health service use and positive psychology outcomes at 6-weeks and 3 months later. Engagement will be evaluated through objective indicators (e.g. number of modules accessed, duration of human support), and subjective indicators (e.g. self-report/verbal feedback). Participants will also have the opportunity to complete a qualitative interview to provide feedback on their satisfaction with the human support. It is hoped that this research will provide participants with additional information and support to improve their quality of life and wellbeing, and to improve our understanding in the psycho-oncology field on how best to offer guidance in online programs.

Given the prevalence of sexual violence and its harmful impacts, there is a critical need for effective primary prevention interventions targeting school settings in Australia. Currently, there is limited evidence of effective primary prevention interventions aimed at stopping sexual violence before it occurs (Our Watch, 2020). Secondary schools represent a promising setting for such efforts, as interventions can reach young people at a pivotal developmental stage—before perpetration may have begun and when norms and values are still being shaped (De Gue et al., 2014; Porat et al., 2024). Consent and healthy relationships education has the potential to prevent sexual violence by equipping students with key skills and attitudes before harmful behaviours emerge. To evaluate the impact of consent and healthy relationships education on sexual violence prevention, this study will employ a cluster-randomised controlled trial (cRCT) involving 12 secondary schools in Tasmania, Australia. Schools will be randomly allocated to either the intervention group (n=6), which will receive the three-session Schools Education Program (SEP), or a waitlist control group (n=6), which will not receive the program during the trial period. For ethical reasons, the control group will be offered the intervention in 2026 after study completion. The primary objective of this cRCT is to assess whether SEP improves Year 9 (ages 13–15) students’ knowledge of sexual violence, including gender equality, consent, healthy relationships, and rape myths. Secondary objectives include evaluating whether SEP enhances students’ attitudes toward gender equality, reduces rape myth acceptance, and increases empathy, as well as behavioural intentions related to consent and bystander intervention. A comprehensive process evaluation and realist evaluation will be conducted alongside the cRCT.