Cancer
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Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. ⋯ The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process.
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Randomized Controlled Trial Comparative Study Clinical Trial
Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma.
Oral mucositis is the dose-limiting toxicity for patients receiving concurrent chemoradiotherapy regimens for tumors of the head and neck area. Currently, the management of established mucositis includes the use of topical anesthetics and systemic analgesics. Based on the clinical evidence of pain alleviation by topical morphine in patients with some inflammatory and painful conditions, a clinical study was undertaken to determine this effect on mucositis-associated pain. ⋯ For patients with head and neck carcinomas receiving concomitant chemoradiotherapy, MO is a simple and effective treatment to decrease the severity and duration of pain and the duration of functional impairment.
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To distinguish true local recurrences (TR) from new primary tumors (NP) and to assess whether this distinction has prognostic value in patients who develop ipsilateral breast tumor recurrences (IBTR) after breast-conserving surgery and radiotherapy. ⋯ Patients with NP had significantly better survival rates than those with TR, but were more likely to develop contralateral breast carcinoma. Distinguishing new breast carcinomas from local disease recurrences may have importance in therapeutic decisions and chemoprevention strategies. This is because patients with new carcinomas had significantly lower rates of metastasis than those with local disease recurrence, but were more likely to develop contralateral breast carcinomas.
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Contemporary therapy for osteosarcoma is comprised of initial treatment with chemotherapy and surgical extirpation of the primary tumor in the affected bone. In view of the major advances forged by chemotherapy in the treatment of the primary tumor, an attempt was made to destroy the tumor exclusively with this therapeutic modality and abrogate surgery. ⋯ Utilizing the regimen employed in the current study, only 3 of 31 patients with osteosarcoma (10%) were cured exclusively with chemotherapy. Four additional patients who underwent extirpation of the primary tumor without disease recurrence and in whom no viable tumor was found in the resected specimens possibly could increase the number of patients who potentially were cured with chemotherapy to 7 (23%). With an overall expected cure rate of 50-65% with "conventional" sin whom no viable tumor was found in the resected specimens possibly could increase the number of patients who potentially were cured with chemotherapy to 7 (23%). With an overall expected cure rate of 50-65% with "conventional" strategies, the results of the current study do not justify the adoption of current forms of chemotherapy as exclusive treatments for osteosarcoma.
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Delirium is common in patients with malignant disease and is associated with significant morbidity. Studies have not examined the epidemiology of delirium in patients undergoing hematopoietic stem cell transplantation (HSCT). The objectives of this study were to determine the prevalence, incidence, severity, and duration of delirium in the acute phase of HSCT and to determine the pretransplantation risk factors for the occurrence and severity of delirium during this period. ⋯ Half of patients who undergo HSCT experience a delirium episode during the 4 weeks posttransplantation. Pretransplantation risk factors can assist in identifying patients who are more likely to develop delirium posttransplantation.