ANZCTR search results

The UCLA shoulder score is used to asess the outcome of rotator cuff surgery in the shoulder. Currently this score is assessed clinically- requiring patients to attend for a doctor's appointment. The hypothesis is that with adequate instruction the patient could complete this form at home and this would increase participation in studies which may follow up patients 10 years later. These patients would not have to travel long distances for a clinical assessment for research purposes only. Patients, assessors 1 & 2 are blinded.

Primary purpose of the trial is to assess the effect of spironolactone on improving heart function, and its ability to reduce the amount of fibrosis (scar tissue) in the transplant heart of patients who have evidence of stiff hearts and therefore likely have increased scar tissue in the hearts. The investigators including cardiologists seeing the participants in the outpatient clinic and performing the cardiac biopsies and coronary sinus blood sampling, nursing staff involved in the heart transplant outpatient clinic, the cardiologists reporting on the Echocardiograms and Cardiac MRI; and the pathologists reporting on the blood investigations will be blinded to the treatment arm that the patient has been randomized into. The research study pharmacist will be performing the randomization from the Pharmacy department at The Alfred Hospital, and records of patient randomization will be stored in a sealed envelope for the duration of the patient's involvement in the trial, but accessible in case it becomes medically necessary (eg for adverse effects) to withdraw the patient from the trial and unblind them.

This Phase IIa trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. All subjects and study personnel will be blinded, except for the person allocating the active or placebo tubes to each subject, based on the randomisation schedule. Thirty subjects will receive the R-flurbiprofen gel, and 10 will receive a placebo gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands. The primary outcome measure will be skin irritation at the site of gel application. Lay statement: This trial will test the safety of a gel when applied to the skin of people who have had at least one non-melanoma skin cancer. A future trial will test if this gel can prevent, or reduce the occurrence of, non-melanoma skin cancer.

The ANZ 0502 (Neo Gem) clinical trial is conducted by the Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) in a number of hospitals in Australia and New Zealand. The trial is for women with newly diagnosed large operable breast cancer or locally advanced breast cancer - which often involves the lymph nodes under the armpit (axillary nodes). Larger operable and locally advanced breast cancers are associated with a poorer prognosis and higher risk of micometastatic disease. Standard treatment for this type of breast cancer usually includes chemotherapy to try to reduce the size of the cancer, followed by surgery and radiation therapy to treat any remaining cancer in the breast. Whilst this treatment is successful in removing the cancer from the breast in the majority of patients, there is a significant risk of the cancer recurring. The treatment in this trial will involve a course of standard chemotherapy (epirubicin and cyclophosphamide) followed by a course of two newer chemotherapy drugs for breast cancer (docetaxel and gemcitabine), followed by surgery. The delivery of chemotherapy prior to surgery offers the potential to substantially reduce the size of primary breast tumours and allow for breast-conserving surgery or surgical resection of previously inoperable tumours. It is hoped to also reduce the risk of recurrence of the breast cancer. The trial includes provision for patients with breast cancer tumours which overexpress HER2, by adding trastuzumab (Herceptin) to the docetaxel and gemcitabine (DGH) treatment cycles in order to maximise the efficacy of all three agents.

Hot flushes are frequent and bothersome to many women previously diagnosed with breast cancer. Fatigue, insomnia, anxiety and mood problems are often related to hot flushes. According to the literature a psycho-educational intervention seems to be a promising treatment for hot flushes but has not been rigorously studied in women with previous breast cancer. The primary purpose of the study will be changes in frequency of hot flushes and daily hot flush score (frequency x severity score for each HF). Hypothesis: A psycho-educational intervention utilising information provision, cognitive behavioural strategies and relaxation training will improve hot flushes, fatigue, insomnia, anxiety and mood disturbance in women with previous breast cancer. The psycho-educational intervention will involve four weekly group sessions during which information about hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) will be given. We will also give strategies to improve and manage these symptoms according to some cognitive-behavioural strategies. In addition relaxation techniques will be taught to try to reduce the frequency/severity of hot flushes.

A Very Early Rehabilitation Trial (AVERT) Randomised controlled trial of very early mobilisation (intervention) versus standard care (control) with blinded assessment of outcome and intention to treat anlaysis. A comprehensive cost eccectiveness sub study is included. It is hypothesised that early mobilisation of patients in addition to standard care alone, will reduce death and disability at 3 months, reduce the number and severity of stroke complications experienced by patients, resullt in a better quality of life and is cost effective.

Prostate cancer is the most common serious cancer in Australian men. Radiotherapy is a common treatment for prostate cancer, which can result in distressing side effects, including urinary and bowel urgency or incontinence (35%), and erectile dysfunction (41% to 55%). These are complex and often chronic conditions, which can adversely affect the patient's quality of life and psychological morbidity. Men with prostate cancer also experience high unmet needs, particularly in relation to sexuality. This research aims to examine the effectiveness of a multi-disciplinary care (MDC) program incorporating consumer involvement to reduce psychological morbidity, unmet needs and improve quality of life in men receiving radiotherapy for prostate cancer using a randomised controlled trial (RCT). 400 men will be recruited and complete baseline measures before being randomised to receive the psycho-educational intervention or usual care. The intervention will comprise of four, 1-hour group consultations led by a clinical nurse consultant, and one individualised nurse session. The consultations occur at critical moments in the illness trajectory: pre-treatment, mid-treatment, end of treatment and 6 weeks post-treatment. The focus of these sessions will be to share common concerns, ask questions and receive information. The content of sessions are tailored to patient concerns. Follow up questionnaires will be administered at the end of treatment, and 6 months post-treatment. The program will be evaluated by comparing results for the control and intervention groups on measures for anxiety and depression, unmet needs, quality of life, distress and preparation for cancer treatment.

While patients with advanced cancer have high levels of unmet needs, a recent systematic review indicated that very few trials of psychosocial interventions have been conducted with palliative patients, and none have been conducted with lung cancer patients. The present research aims to evaluate a supportive care program for patients with inoperable lung cancer who have a potentially limited life expectancy, using a randomised controlled design. 210 patients will be recruited and asked to fill out baseline measures of anxiety/depression, unmet needs and quality of life. Participants will then be randomised to receive either the intervention or usual care. Permission will be sought from participants to obtain information about medical variables from their medical record. Oncologists will provide information about each participant’s treatment plan, performance status, and awareness of prognosis, and will refer intervention participants to two supportive care sessions. Participants will be encouraged to bring a significant other(s) with them to the supportive care sessions. The content of each session will be tailored to respond to needs identified in the baseline data. The first group session will be timed to correspond with the beginning of treatment, and the second will occur at the end of treatment. In addition, baseline data summaries for each intervention patient will be made available to the treating team to assist them in meeting the patient’s needs. Where particular needs are identified, appropriate referrals will be made (e.g. to social work, psychology etc) by the Lung clinical nurse coordinator. Follow-up measures (anxiety/depression, unmet needs, quality of life and needs related to treatment preparation) will be administered at 8 and 12 weeks post baseline when patients attend the clinic at these approximate time points.

Delirium is common in patients with advanced cancer, and presents with symptoms of disturbed sleep, attention, and/or memory; and restlessness or drowsiness. The cause of this is believed to be due to a disturbance of the cholinergic transmitter system in the brain. This could be due to anticholinergic activity of medication, or substances produced in acute illness. It is not possible to measure these abnormalities in the brain in the clinical setting, so a surrogate marker(s) that is routinely measured would be useful. A serum anticholinergic assay can quantify anticholinergic activity in the blood. We aim to measure this on admission to a palliative care unit, and at an episode of delirium, and look at its levels in relation to its ability to predict the occurrence of delirium. We will also look for associations with other simple clinical and investigational measures, so a model can be developed to more accurately predict those at risk of delirium so preventive strategies and early identification can be utilised.