Bmc Cancer
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Randomized Controlled Trial Multicenter Study
Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.
Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR. ⋯ If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population.
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Randomized Controlled Trial Multicenter Study Comparative Study
CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients.
Low-molecular-weight heparin (LMWH) is recommended and commonly used for extended treatment of cancer-associated thrombosis (CAT), but its superiority over warfarin has been demonstrated in only one randomised study. We report here the rationale, design and a priori analysis plans of Comparison of Acute Treatments in Cancer Haemostasis (CATCH; NCT01130025), a multinational, Phase III, open-label, randomised controlled trial comparing tinzaparin with warfarin for extended treatment of CAT. ⋯ The results will add significantly to the knowledge of the efficacy, safety and cost effectiveness of tinzaparin in the prevention of recurrent VTE in patients with cancer and thrombosis. Prospective data will emerge on the clinical significance of incidental VTE and risk stratification in patients with CAT. Results on post-thrombotic syndrome, quality of life and healthcare resource utilisation will inform decision makers on how to secure better patient care. If tinzaparin is shown to be more effective than warfarin, CATCH will provide valuable confirmatory data to support the use of the LMWH tinzaparin for extended treatment of CAT.
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Multicenter Study Comparative Study
Differences in the symptom experience of older versus younger oncology outpatients: a cross-sectional study.
Mortality rates for cancer are decreasing in patients under 60 and increasing in those over 60 years of age. The reasons for these differences in mortality rates remain poorly understood. One explanation may be that older patients received substandard treatment because of concerns about adverse effects. Given the paucity of research on the multiple dimensions of the symptom experience in older oncology patients, the purpose of this study was to evaluate for differences in ratings of symptom occurrence, severity, frequency, and distress between younger (< 60 years) and older ( ≥ 60 years) adults undergoing cancer treatment. We hypothesized that older patients would have significantly lower ratings on four symptom dimensions. ⋯ This study is the first to evaluate for differences in multiple dimensions of symptom experience in older oncology patients. For almost 50% of the MSAS symptoms, older patients reported significantly lower occurrence rates. While fewer age-related differences were found in ratings of symptom severity, frequency, and distress, a similar pattern was found across all three dimensions. Future research needs to focus on a detailed evaluation of patient and clinical characteristics (i.e., type and dose of treatment) that explain the differences in symptom experience identified in this study.
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Randomized Controlled Trial Multicenter Study
Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers.
Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers. ⋯ The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes).
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In China, there are currently no approved therapies for the treatment of metastatic renal cell carcinoma (mRCC) following progression with vascular endothelial growth factor (VEGF)-targeted agents. In the phase 3 RECORD-1 trial, the mammalian target of rapamycin (mTOR) inhibitor everolimus afforded clinical benefit with good tolerability in Western patients with mRCC whose disease had progressed despite VEGF receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. This phase 1b study was designed to further evaluate the safety and efficacy of everolimus in VEGFr-TKI-refractory Chinese patients with mRCC. ⋯ Safety and efficacy results were comparable to those of the RECORD-1 trial. Everolimus is generally well tolerated and provides clinical benefit to Chinese patients with anti-VEGF-refractory mRCC.