No abstract

The aim of this pilot study was to test the feasibility and acceptability of a family carer intervention for carers of patients with high-grade glioma (HGG). The intervention consisted of: (1) an initial telephone assessment of carer needs; (2) a personalised tabbed resource file; (3) nurse-led home visit; and (4) ongoing telephone support. Two consumer representatives reviewed the intervention resources. The intervention was then piloted with participants who were the primary carer for patients undergoing treatment for HGG in Western Australia. Two consumers provided feedback on the resource, and 10 carers participated in the pilot. Positive feedback was received about the resource manual and intervention. Suggestions were also made for changes which were implemented into the trial. The surveys were shortened based on feedback. Participants identified a large range of issues during nursing assessments which would not otherwise be identified or addressed for carers receiving routine care. As a result of providing the intervention, the nurse was able to make referrals to address needs that were identified. This pilot study enabled us to refine and test the Care-IS intervention and test the feasibility and acceptability of proposed survey instruments. We were also able to estimate recruitment and retention and the overall study timeline required for the randomised controlled trial we are now conducting. It has also demonstrated the role of the nurse who delivered the intervention and allowed us to refine communication and referral pathways.

An exploratory study involved observation of four clients of the Botleys Park Sensory/Snoezelen Environment (SSE) in both the SSE and the villa. The clients were not known to the observer and were selected at random. The aim of the study was to explore the hypothesis that a designed change in care will give rise to an observable change in the behaviour of the recipients of that care. The results indicated that there was an apparent difference in the behaviour of the four clients observed between the villa and the SSE. It was concluded that although the study did not allow proof of the hypothesis, it did indicate that there was an observable change in behaviour, which provided evidence that the hypothesis could withstand a design that would allow the hypothesis to be tested.

During 1972-3 a survey was made of the pattern of communication between 80 consultants in four hospitals in southeast England and 100 general practitioners in the catchment areas of these hospitals. This aimed to identify the factors which affect the efficiency of communication between these two groups and to look for ways of improving this. Face to face contact between consultants and general practitioners was extremely limited. The main communication links were the letters of referral and discharge, but even this form of communication had serious defects. Though most doctors were satisfied with communications in general the evidence suggested ways of improving communication between consultants and general practitioners, such as encouraging domiciliary visits where both doctors are present and consultant sessions in health centres, but that any innovation in this field could only be successful if the attitude of the consultants and general practitioners were in harmony with the new venture.

BackgroundDespite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration.Methods and designThe BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use.Trial registrationThis trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000513718).