Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients (PROTECT) : rationale and design of a randomized controlled trial

Published: 6 January 2014BACKGROUND: Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted. METHODS/DESIGN: This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs. DISCUSSION: This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.Patricia M Livingston, Richard H Osborne, Mari Botti, Cathy Mihalopoulos, Sean McGuigan, Leila Heckel, Kate Gunn, Jacquie Chirgwin, David M Ashley and Melinda William

Does Multidisciplinary Care Enhance the Management of Advanced Breast Cancer?: Evaluation of Advanced Breast Cancer Multidisciplinary Team Meetings

In recent years, the multidisciplinary approach has become the standard of care in cancer management. However, evidence demonstrating the value of multidisciplinary care and team meetings remains scarce

Is chemotherapy dose intensity adequate in breast cancer management in the Australian healthcare setting: a retrospective analysis

AimTo determine the adequacy of chemotherapy received dose intensity (RDI) in breast cancer treatment in a general population and to identify factors that influence RDI.MethodsA retrospective analysis of breast cancer patients who commenced a course of i.v. chemotherapy in 2008 was undertaken. Data were collected on patient and tumor characteristics, chemotherapy regimen, dose (including delays, reductions and the reasons for these), granulocyte colony-stimulating factor (G-CSF) use and febrile neutropenia incidence. RDI was calculated using the planned and actual dose received and time taken. A level of &ge;85% RDI was considered acceptable for treatment given with curative intent.ResultsIn all, 131 patients (aged 28 to 77 years) received chemotherapy in adjuvant (n&thinsp;=&thinsp;76, 58%), neoadjuvant (n&thinsp;=&thinsp;11, 8%) and metastatic settings (n&thinsp;=&thinsp;44, 34%). RDI did not reach 85% for 12% adjuvant, 36% neoadjuvant and 34% metastatic cases (&chi;2&thinsp;=&thinsp;10.55, P&thinsp;=&thinsp;0.005). Overall, 43% of patients received G-CSF.ConclusionAcceptable chemotherapy RDI was delivered for most patients in the adjuvant setting but not in the neoadjuvant setting. G-CSF treatment contributed to the optimization of dose intensity in the adjuvant setting only. Dose intensity in the metastatic setting was considered satisfactory where quality of life is the primary focus. Other factors can be modified to improve RDI.<br /

Rational use of trastuzumab in metastatic and locally advanced breast cancer: implications of recent research

The management of HER2-positive metastatic breast cancer, a disease renowned for its aggressive natural history, has been revolutionized by the introduction of trastuzumab. Indeed, outcomes for patients with HER2-positive advanced breast cancer are now equivalent to, if not better than, those of their HER2-negative counterparts. Since the pivotal registration trial, a wealth of new clinical data has emerged regarding the use of trastuzumab in a variety of clinical contexts - adding to the evidence but also highlighting areas of uncertainly and debate. These include the optimal partner chemotherapy(ies) to trastuzumab; the effectiveness of combining trastuzumab with endocrine therapy; the benefits of continuing trastuzumab after progression on a trastuzumab-containing regimen; and the role of trastuzumab in locally advanced and inflammatory breast cancer. In this paper we review major clinical trials addressing these questions, clinical recommendations that can be made as a result, and the strength of evidence that supports them. Finally, we identify areas of ongoing uncertainty, and propose recommendations for future research in this field

Systemic treatment of HER2+ metastatic breast cancer: clinical conundrums and future perspectives

Improvements in the treatment of metastatic HER2-positive breast cancer constitute one of the great advances in breast cancer medicine of the last generation. From being a highly aggressive fatal condition, the use of anti-HER2-targeted therapies, in particular trastuzumab, has led to significant improvements in disease outcomes. There are reports of increasing numbers of patients alive and well more than 5 years from diagnosis of metastatic disease. Nevertheless, there remain many complex and clinically difficult scenarios where there is little in the way of randomized evidence or published guidelines to guide decision making. As a companion piece to our review of HER2-targeted therapies in the metastatic setting, we decided to focus on a series of clinical scenarios that fell outside of the standard trial-based settings and where opinions and guidance from experienced clinicians and experts in the field would be considered useful to help develop safe and effective treatment strategies. The following eight cases were put forward by our panel of experts, voted on by their peers to select the most relevant and interesting cases, and the discussions worked on by teams of two followed by review and commentary by another team of two