ANZCTR search results

The aim of this study is to assess the safety and efficacy of a novel anti-cancer drug called SON-DP in patients with advanced or metastatic solid tumours that have relapsed or are not responding to standard treatment. This novel anti-cancer drug is different from the traditional cancer cell killing drug as it is expected to transform cancer cells into normal tissue cells via a SON-DP induced cancer cell reprogramming and re-differentiation process. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and you have a histologically confirmed locally advanced or metastatic solid tumour that is relapsed or not responding to currently approved therapies. Study details All participants will be treated with SON-DP administered via a 90 minute intravenous infusion twice per week in 28-day cycles, for a maximum of 6 cycles. The first few participants enrolled will start at a low dose, and will be assessed for safety and anti-cancer activity of the drug. If determined to be safe, the next participants enrolled will receive a higher dose level, or alternatively will receive a lower dose level if side effects are experienced. For the duration of treatment and up to 1 month after completing treatment, participants will undergo blood tests and imaging to determine the safety and anti-cancer efficacy of SON-DP. Participants may also be asked to undergo tumour biopsies, although this will be voluntary for participants receiving lower dose levels. It is hoped that this study will show that this novel drug is safe and effective for the treatment of patients with advanced or metastatic solid tumours that have relapsed or are not responding to standard treatment. The information in this phase 1a study will be used to determine the optimal dose of SON-DP for future treatment of similar patients.

Members of the LGBTQIA+ (lesbian, gay, bisexuals, transgender, queer, intersexual, asexual, plus other gender, sexual, or romantic minority identities) are at higher risk of poor mental health. One therapeutic approach that has been shown to improve mental health for this community is Acceptance and Commitment Therapy (ACT). In addition, digital programs that promote mental health have been shown to be effective and acceptable in this community. This project aims to conduct the first randomised control trial (RCT) evaluating a digital mental health promotion program underpinned by ACT with the LGBTQIA+ community. The intervention used in this program is called YOLO (You Only Live Once), which has demonstrated efficacy in improving mental health with university students. Findings from this RCT will inform changes necessary to the YOLO program to co-design a world-first digital ACT program for LGBTQIA+ people. This trial will involve three distinct phases. Phase 1 involves the quantitative evaluation of efficacy based on self-report data on measures of mental health and ACT processes. This will determine the efficacy of the program to improve mental health. Phase 2 involves the qualitative analysis of feedback provided during YOLO modules. Phase 3 involves interviews with participants about their experiences with the YOLO program and desired changes. Both phases 2 and 3 will inform changes to the YOLO program to make it more LGBTQIA+ affirming in future projects. This research is guided by six research questions: Question 1: Will the YOLO program be associated with improved mental health for members of the LGBTQIA+ community compared to a waitlist control? Question 2: What changes will participants recommend to improve the usability of the program and make it LGBTQIA+ affirming? Question 3: Will the YOLO program improve ACT processes for members of the LGBTQIA+ community compared to a waitlist control? Question 4: Will ACT processes mediate the mental health changes that occur during the RCT? Question 5: Does completion rate influence the mental health outcomes experienced during the RCT? Question 6: Do changes in ACT processes mediate the relationship between LGBTQIA+ minority stress and mental health outcomes? In brief, we hypothesise that completing the program will improve the mental health of participants. We anticipate high usability, but a myriad of changes recommended to make the program more affirming. We further predict that ACT processes will improve throughout the trial and that these changes will influence the mental health outcomes gained. As well, we predict that completion amount of the program will influence the mental health outcomes and changes in ACT processes reported, in that those who complete all modules will report higher mental health and ACT process changes. We finally predict that the relationship between LGBTQIA+ minority stress and mental health will be influenced by ACT processes.

This study aims to compare the agreement in echocardiographic findings between and within three defined groups: cardiac sonographers, junior clinicians and senior clinicians, when performing transthoracic echocardiography on critically unwell patients. This information is vital when comparing scans performed by different operators and making clinical decisions based on the differences between the two scans.

Women will be recruited from the Women's and Children's Hospital GDM clinic. At enrolment, participants will be asked to complete the following measures: height and weight, blood pressure, non-fasting blood test, a web-based dietary survey, and a 5-item questionnaire on behaviour change. Women will then be randomised to the control (standard GDM care) or the intervention group (standard care + personalised dietary advice and health coaching). The intervention group will receive guidance on food choices to increase intake of whole fruits, vegetables, and nuts, decrease intake of ultra-processed foods, and modify cooking oils. Dietary advice will be culturally informed. At 36-38 weeks pregnancy, participants will be asked to repeat the measures they completed at baseline. The feasibility of the recruitment criteria and acceptability of the intervention will be evaluated.

State-based Guidelines were issued for Early Childhood Education and Care (ECEC) services recommending greater time outdoors and inclusion of indoor-outdoor programs to facilitate social distancing to reduce spread of COVID-19. The aim of this 3-arm randomised controlled trial was to examine the impact of different dissemination strategies on increasing ECEC service intentions to adopt recommendations from the Guidelines. The intervention was designed to address key determinants of guideline adoption including awareness and knowledge. Participants were randomly assigned to receive either a generic email (control group) or an email that included a link to an e-newsletter or animated video (intervention groups) with further information regarding the Guidelines. It was hypothesised that services receiving the e-newsletter or animated video would have a greater intention to adopt the Guidelines. Following delivery of the intervention in September 2021, services were invited to participate in an online or telephone survey from October-December 2021. This study found potential for the inclusion of interactive strategies to disseminate policy and guideline information within the ECEC setting, in the context of the need for rapid communication. Further research should explore the added benefits of embedding such strategies within a multi-strategy intervention.

Shoulder pain affects up to one in four people at any time(1) and is a common reason for people to visit a health professional.(2) Rotator cuff-related shoulder pain is the most common cause of shoulder pain (~85%)(3) and is an umbrella diagnosis that captures pathology related to the rotator cuff (e.g. tendinopathy, tear, tendinitis, calcific tendinitis) or subacromial bursa (e.g. bursitis). Advice and education are recommended in clinical practice guidelines for most musculoskeletal conditions. For low back pain, 86% of guidelines recommend advice to maintain normal activities, 72% recommend reassurance on the favourable prognosis of low back pain, and 92% recommend against bed rest.(5) For neck pain, 73% of guidelines recommend advice to stay active and to avoid rest for greater than three days.(6) Yet for rotator cuff-related shoulder pain, only one guideline recommends advice to resume usual activities and providing information about the benefits and harms of treatment options.(7) This is likely due to a paucity of trials evaluating advice/education as an intervention. The primary aim of this study is to investigate the comparative effectiveness of three forms of advice on reassurance in people with rotator cuff-related shoulder pain. We also aim to: - Investigate the effectiveness of three forms of advice on intentions to stay active, see a health professional, see a specialist, and request imaging - Investigate the credibility and relevance of three forms of advice - Explore people’s feelings and perceived treatment needs evoked by three forms of advice. We hypothesise best-practice advice plus pain science education will be more reassuring than best practice advice alone and structure focused advice, and have a more beneficial effect on the other secondary outcomes. REFERENCES 1. Luime JJ, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. 2. Rekola KE, et al. Use of primary health services in sparsely populated country districts by patients with musculoskeletal symptoms: consultations with a physician. J Epidemiol Community Health. 1993;47(2):153-7. 3. Ostor AJ, et al. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatol. 2005;44(6):800-5. 4. Whittle S, Buchbinder R. In the clinic. Rotator cuff disease. Ann Intern Med. 2015;162(1):Itc1-15. 5. Oliveira CB, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018;27(11):2791-803. 6. Parikh P, et al. Comparison of CPG’s for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Dis. 2019;20(1):81. 7. Doiron-Cadrin P, et al. Shoulder Rotator Cuff Disorders: A Systematic Review of Clinical Practice Guidelines and Semantic Analyses of Recommendations. Arch Phys Med Rehabil. 2020;101(7):1233-42

A diagnosis of Fetal Alcohol Spectrum (FASD) can adversely affect wellbeing and functioning across the life-course. This highlights the importance of early intervention. The Australian Government is committed to reducing the health risks associated with alcohol and have, as one of their key priorities, better diagnosis and management of FASD (e.g., Australian Government Action Plans to Reduce Impact of FASD; National Disability Strategy 2010-2020). This project will compare two existing evidence-based interventions for supporting families with a child who has a diagnosis of FASD: the family-focused Parents Under Pressure program (PuP) and the Alert® child-focused self-regulation program. The research will examine if there are any differences between the approaches using a range of outcome measures (e.g., child socioemotional wellbeing, parent stress, quality of the caregiving relationship), and examine these changes alongside implementation considerations (e.g., costs) to inform future policy and practice. It is anticipated that child executive function and behavioural and/or emotional regulation - along with caregiver stress and emotion regulation - will improve after receiving either intervention. Due to the family-focused nature of the PuP program, it is anticipated that there will be a greater reduction in caregiver stress and greater improvement in caregiver emotion regulation and emotional availability for families who participate in the PuP program versus the Alert® intervention.

Current psychological treatments for child anxiety are well-established and evaluated, yet up to half of children still have an anxiety disorder after treatment. According to guidelines by RANZCP, following unsuccessful treatment with a psychological program, children should be moved to a course of SSRI medication. While this sounds like a logical suggestion, it is currently not based on any scientific evaluation. The aim of this pilot study is to evaluate both the effectiveness of this approach and its implementation in the Australian community. Children aged 7-12 years who have current anxiety disorders will be treated with a scientifically tested psychological program in university services. Following this, children who still have a diagnosable anxiety disorder will be randomly allocated to either treatment as usual (continued practice of learned skills) or will receive a referral with detailed information recommending SSRI treatment to their current medical practitioner. Improvements in diagnoses, anxiety symptoms and life impairment will be assessed 15 weeks later, along with feasibility, acceptability and other implementation data such as how many medical practitioners agree to prescribe.

The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on sperm quality, integrity, content and epigenetic programming. Participants will receive dietary interventions of either a processed western dietary intake pattern - the “processed diet”, or an unprocessed, whole foods dietary intervention meeting the Australian Dietary Guidelines - the “unprocessed diet”. The main purpose of these interventions is to determine how and if the semen quality and epigenetic state of sperm are altered based on acute changes to dietary intake in men of reproductive age. We are specifically interested in determining how nutrient intake alters the epigenetic state of sperm, in a manner that has the potential to affect the development and health of offspring. This study will strengthen our understanding of how paternal lifestyle prior to conception may play a role in influencing the health and epigenetic status of future generations. It is hypothesized that men on the unprocessed diet versus men on the processed diet will induce different epigenetic changes to the sperm at regions involved in development and metabolism.

This study aims to compare the effect of a single bout of exercise on endocannabinoid (eCB) and affective (mood) responses in adults with cancer currently receiving chemotherapy treatment versus their healthy peers, and to evaluate relationships between eCB and mood responses to exercise. Who is this study for? You may be eligible for this study if you are a cancer patient aged 18 or older, and currently receiving chemotherapy treatment; and if you are an apparently healthy adult (age 18+) . Study details All participants will engage in a single testing session involving seated rest (30 min) followed by a moderate exercise bout on treadmill or exercise cycle (30 min). Participants will be asked to fill in mood surveys and provide blood samples before and after the seated rest and exercise conditions. It is hoped that findings from this study will help inform future trials investigating the benefits and barriers to exercise in cancer patients.