Purpose: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients.Methods and Materials: Eligible patients included those with head-and-neck cancer with radiation ports encompassing > 50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 mu g/m(2) or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system.Results: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006).Conclusion: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer. (c) 2007 Elsevier Inc.

Phenomenology has different meanings in philosophical history. For G.W.F. Hegel, phenomenology is an approach to philosophy that begins with an exploration of phenomena (what presents itself to us in conscious experience) as a means to finally grasp the absolute, logical, ontological and metaphysical spirit that is behind phenomena. For Edmund Husserl, phenomenology is an approach to philosophy that takes the intuitive experience of phenomena (what presents itself to us in conscious experience) as its starting point and tries to extract from it the essential features of experiences and the essence of what we experience. This study strives to define that patient–nurse experience and what impact it has on the nurse in clinical learning and nursing practice.

PURPOSE To evaluate the reliability and validity of the Japanese translation of Quality of Life Radiation Therapy Instrument (QOL-RTI) and the head and neck module (H&N) for Japanese patients being treated with radiotherapy for head and neck malignancies. MATERIALS & METHODS The QOL-RTI/H&N was translated into Japanese by a preliminary QOL research working group of JASTRO and was used in this clinical trial. From 1998 to 2001, 70 patients with head and neck malignancies for whom radical radiotherapy was planned were entered into this study. Patients were requested to answer the questions before radiotherapy at baseline, twice during week 4 of therapy (for test-retest reliability), at the end of treatment, and 3 months, 6 months, 1 year and 2 years from the beginning of radiotherapy. Internal consistency was assessed by Cronbach's alpha coefficient. Validity was assessed by comparing the results with EORTC-QLQ-C30 and with QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ADC). Patient compliance and test sensitivity were also analyzed. RESULTS Cronbach's alpha coefficient was 0.79 to 0.93 depending on the time point for the evaluation. Test-retest reliability was acceptable, with a Pearson coefficient of 0.83 for QOL-RTI and 0.92 for H&N module. Compliance with this scheme was 98.2%. The QOL-RTI was sensitive enough to detect significant changes in the QOL score during and after the course of radiotherapy. Agreement with the EORTC-C30 was good with a high Pearson correlation coefficient of 0.648 and that with QOL-ADC was also good with a coefficient of 0.566. The factors analyzed consisted of 11 functional/health-oriented questions, 5 emotional/ psychological, 5 socio-economic/ family and 2 general. CONCLUSION The Japanese version of QOL-RTI with H&N module was found to be reliable and sensitive enough to evaluate variation of QOL in patients with head and neck malignancies during and after radiotherapy.

Cancer therapy is associated with inherent adverse effects and the need for complete, consistent and accurate reporting of toxicity is paramount in multicenter cooperative oncology clinical trials. Accurate toxicity information is essential to weigh the costs and benefits associated with new treatment regimens. A major issue faced by investigators and clinical trial coordinators today is the lack of clear directions regarding what method should be used in toxicity assessment in cooperative oncology clinical trials. Research personnel are faced with two options: (1) to be proactive and use a "directed" method of toxicity assessment or (2) to simply follow the data trail and report selected toxicity based only on routine documentation in the chart. The differences between these two approaches may be immense depending on one's perspective. The purpose of this article is to review how the current methods of toxicity assessment evolved and discuss issues and concerns in toxicity assessment in a challenging healthcare environment where clinical trials continue to increase in complexity and workload through the use of novel and multimodality therapies. The potential implications for toxicity data management practices, data quality, patient care management and resource utilization are discussed.

BACKGROUND:Quality of life (QOL) measures give patients the possibility to express subjective changes in wellbeing. We aimed to translate the radiation specific quality of life questionnaire (QOL-RTI) and the companion head and neck module (H&N) questionnaire into German and to test its reliability, validity and sensitivity.PATIENTS AND METHODS:After translation and final revisions based on qualitative interviews with ten patients, 97 head and neck cancer patients were screened for eligibility. Patients answered the 38 items questionnaire at baseline and twice in week 4 of radiotherapy for test-retest reliability. Internal consistency was calculated using Chronbach's alpha. Patients also completed the functional assessment of cancer tool plus head and neck (FACT-G plus H&N) for concurrent validity. Item analyses were performed to test the sensitivity.RESULTS:Chronbach's alpha yielded alpha = 0.85 for the QOL-RTI and alpha = 0.80 for the H&N module, test-retest reliability scores were r = 0.87 and r = 0.83, respectively. The correlation of the QOL-RTI plus H&N and the FACT plus H&N was r = 0.79. Questionnaire sensitivity was supported by significant changes in the mean score of 45.8% of the QOL-RTI items and 78.6% of the H&N items between baseline and week 4 of radiotherapy.CONCLUSIONS:The German version of the QOL-RTI was shown to be a reliable, valid and sensitive tool to assess the quality of life of patients undergoing radiotherapy. The H&N module is useful for patients undergoing treatment for head and neck cancer.

PURPOSE:The oral complications associated with radiotherapy to the head and neck are a significant dose-limiting factor. The goals of this study were to determine whether oropharyngeal rinsing and ingestion of misoprostol protect mucous membranes from the acute effects of irradiation, and to evaluate the quality-of-life (QOL) outcomes of patients receiving misoprostol. We report the results of the QOL outcomes of patients in this study. METHODS AND MATERIALS:A total of 33 patients with resected or intact cancer of the oral cavity, oropharynx, supraglottic larynx, or hypopharynx were registered to receive postoperative radiotherapy plus misoprostol or primary radiotherapy plus misoprostol. All patients were scheduled to receive 60-70 Gy at 2 Gy/d within 6-7 weeks. QOL and function were evaluated. RESULTS:A decrease in the QOL and function occurred in all areas covered by the questionnaire at the 6-week interval. This decrease was significant for eating, saliva, taste, and mucous. Of these significant factors, taste, saliva, and mucous consistency had not resolved by 12 weeks. CONCLUSION:Increased understanding of the impact of treatment on QOL and symptoms will formulate the rational design of toxicity interventions and enhance the multidisciplinary care of head-and-neck patients.

PURPOSE:To (1) measure radiation therapy costs for patients in randomized controlled clinical trials, (2) compare measured costs to modeling predictions, (3) examine cost distributions, and (4) assess feasibility of collecting economic data within a cooperative group. METHODS:The Radiation Therapy Oncology Group conducted economic pilot studies for two Phase III studies that compared fractionation patterns. Expected quantities of Current Procedural Terminology (CPT) codes and relative value units (RVU) were modeled. Institutions retrospectively provided procedure codes, quantities, and components, which were converted to RVUs used for Medicare payments. Cases were included if the radiation therapy quality control review judged them to have been treated per protocol or with minor variation. Cases were excluded if economic quality review found incomplete economic data. RESULTS:The median and mean RVUs were within the range predicted by the model for all arms of one study and above the predicted range for the other study. CONCLUSION:The model predicted resource use well for patients who completed treatment per protocol. Actual economic data can be collected for critical cost items. Some institutions experienced difficulty collecting retrospective data, and prospective collection of data is likely to allow wider participation in future Radiation Therapy Oncology Group economic studies.

The impact of the structure and organization of clinical research services (data management model) on the workload of clinical research coordinators (CRCs) at investigative sites is undocumented. This paper describes three types of data management models and their potential influence on the workload of CRCs. A 20-item survey, covering information about accrual to clinical trials, staffing levels, use of workload measurement tools, and the data management model, was e-mailed to nine CRCs working at selected cancer centers in the United States. Six CRCs representing four university-based institutions and two community hospitals responded. Staffing levels and number of patients placed on clinical trials varied by institution and data management model. One out of six centers used a workload formula based upon the time it takes to complete a task. The centralized clinical data management model and the modified/mixed models were common. Our findings suggest that it is important to understand the structure of the clinical data management model, among other factors, in evaluating the workload of CRCs.

Purpoealobjectfve: Ths incidence of prostate cancer has tripled over the last 10 years, co&led over the last four years and continues to increase. A common method of treating prostate cancer is with external bsam radiotherapy with or without hormones. Accurate and comprehensive documentation through prospective studies with long term follow-up is necessary to reduce the negative impact of treatment on a patient% quality of life. While it is increasingly recognized that radiation therapy tmatment for prostate cancer may result in permanent alteration of the patient’s quality of life, the extent and timing of this change in quality of life has not been adequately investigated in a comprehensive and prospective manner. Furthermore, there are limited instruments developed for use with patients undergoing definitive radiotherapy. The purpose of this paper is to report on the validation of the Quality of Lie Radiation Therapy Instrument (QOL-RTI), a 24-item visual analogue general quality of life tool developed for use with patients receiving radiotherapy. Materials & Methods: Health related quality of life was assessed in a prospective study of 62 patients treated with either combined hormonal therapy (HT) plus external beam radiotherapy (EBRT) or EBRT alone for locally advanced prostate cancer. Quality life was measured prospectively before, during, and after radiation therapy. Results: The estimeted reliability of the subscales was assessed with coefficient alpha which ranged from 0.57 to 0.66. Internal consistency was calwlated using initial questionnaires for tha entire sample, yielding a Cronbach’s alpha of 0.82. Test-retest produced a correlation coeffitient of 0.75 (p

The Committee met at the time of the International Association for the Study of Lung Cancer in Belgium to discuss the current status of postoperative adjuvant therapy for completely resected non-small cell lung cancer. The Committee agreed unanimously that both postoperative chemotherapy and radiation therapy are unproven treatment modalities and should be considered under investigation. The Committee felt that the evidence that postoperative radiotherapy or chemotherapy prolongs survival is marginal at best and inconclusive. Therefore, certain subsets should be studied with postoperative adjuvant trials - including pathological stages TlNl, T2N1, T2NO. These patients only have a 40% to 55% 5-year survival and they should bc considered for investigational adjuvant trials. In addition, patients who are mediastinoscopy negative but prove to be N2-positive at the time of thoracotomy should also be considered for an adjuvant trial, The group of patients described above represents the largest population of resected lung cancer: approximately 30,000-40$00 such patients undergo each year surgical resection in the United States. Thus, the major impact on cure rates is found within this subsets of patients, T3NO should be excluded because this group is too heterogeneous; it would be too difficult to uniformly categorize these patients. The Committee enthusiastically endorsed preresectional surgical staging consisting of at least mediastinoscopy and possible parastemal exploration. The Committee also unanimously endorsed the necessity of careful intraoperative staging at the time of surgical resections. Adequate staging should consist of at least 34 different mediastinal lymph nodes stations being sampled. The Committee strongly recommends that all studies should stratify for cell type and stage. When postoperative adjuvant trials are designed certains facts should be considered: