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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.

New approaches to the treatment of advanced oesophago-gastric cancer are likely to involve biologically relevant targets, which either alone or in combination with chemotherapy, may result in prolonged disease stabilisation or tumour response, hence improving patient outcomes (QOL, symptom control and survival). One such biological target is the epidermal growth factor receptor (EGFR). The role of EGFR in advanced oesophago-gastric cancer is unknown although high EGFR expression is known to occur in around 60-80% of patients and is associated with an adverse prognosis and resistance to chemotherapy. Furthermore, responses have been observed using agents targeting EGFR in advanced oesophago-gastric cancer. Cetuximab is a well-characterised, relatively non-toxic antibody directed against EGFR. Cetuximab has been used as a single agent and in combination with chemotherapy in a variety of cancers. Hence it seems appropriate to examine the role of cetuximab in advanced oesophago-gastric cancer. Considering the fact that docetaxel based regimens appear highly active in advanced oesophago-gastric cancer, there is a strong rationale for combining docetaxel with cetuximab. Synergy between taxanes and other agents targeting the family of EGFRs has been observed in other types of cancer. Therefore we have developed this Phase II study of cetuximab plus docetaxel in patients with advanced (recurrent or metastatic) oesophago-gastric cancer who are refractory to docetaxel therapy. This is an optional extension study for patients who have participated in ATTAX (AG0603) (all of whom receive docetaxel) and who have progressed either during or within 6 months of docetaxel based chemotherapy.

Velcade is a new drug, which is being developed for the treatment of patients with a variety of cancers. In studies to date, it has been shown to be useful in the treatment of patients with advanced multiple myeloma whose myeloma has progressed after standard drug treatment. Approximately one third of them have had a response to treatment, which has lasted for approximately 12 months. It has been associated with improvement in symptoms from the disease including improvements in blood counts, fewer blood transfusions and in a lessening of bone pain. There is some evidence that more patients respond to Velcade when it is given together with a steroid drug, Dexamethasone, which is commonly used in the treatment of Myeloma, and you may have received in the past. Only a small number of patients have been treated with Velcade and Dexamethasone from the beginning of therapy. However, many more have had Dexamethasone added later if they have failed to respond to Velcade on its own. Velcade is approved in the USA and Europe by the Food and Drug Administration (FDA) for the treatment of patients with myeloma. However, Velcade is not approved in Australia and therefore its use in this study is considered experimental. This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients who respond to Velcade in the controlled setting of a clinical trial. This study is specifically designed for patients who have received at least one kind of standard treatment in the past and are now in need of further therapy because their disease has relapsed. The second aim of this study is to see whether treating patients with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control. This is known as maintenance treatment. Approximately 100 patients will participate around Australia.

The reported incidence of painful Achilles tendinosis is 6-17% amongst adult athletes. This condition results in considerable impairment of training and performance in athletes. To date, evidence suggests that of the treatment strategies investigated, exercise programs that involve mildly painful eccentric contractions of the muscles of the calf are the most effective at reducing pain and improving function for people suffering from this condition. Although the underlying mechanism conferring improvement is unknown, there is now some evidence suggesting a link between the presence of newly formed blood vessels (neovascularisation) and painful tendinosis. With a program of mildly painful eccentric loading exercises, there is a sustained reduction in pain with disappearance of these new vessels. Similar sustained reductions in pain have been shown with prolotherapy injections of hypertonic glucose and local anaesthetic. Prolotherapy involves the repeated injections of an irritant solution with the intention of sclerosing neovessels and stimulating inflammation and subsequently new collagen formation. With respect to Achilles tendinosis, the relative efficacy of these two approaches, individually and in combination, has not been tested. This project aims to conduct a pilot randomised clinical trial comparing prolotherapy injections eccentric loading exercises singly and in combination. It will be conducted in research clinics to be set up at Logan and in Christchurch, New Zealand. It will be a single blinded trial with the assessor being the blinded person. Experience and information from this pilot trial will be used to inform an adequately powered randomised clinical trial of prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis.

The purpose of this project is to test a new way of providing patients with information about chemotherapy. Previous experience has shown that many patients feel anxious before starting chemotherapy treatment, and would like the opportunity to discuss their concerns about treatment, treatment related side effects and ask questions. Patients will be randomly allocated to receive either the usual chemotherapy education program or the new chemotherapy education program we are testing. The two groups will be compared on measures of psychological distress, symptoms/side effects of chemotherapy, confidence in dealing with side effects of chemotherapy and unmet needs.