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Lung cancer is the most common cancer worldwide, accounting for 1. According to a recent review by Islami et al. These facts highlight the importance of pushing lung cancer research forward.

Introduction

Recognizing the growing importance of quality of life QoL as an end point in clinical studies, the European Organization for Research and Treatment of Cancer EORTC has developed a questionnaire module for the assessment of QoL in lung cancer patients to be used in conjunction with the core questionnaire QLQ-C30 [ 8 ].

Since its publication in , major advances have been made with regard to diagnostic and therapeutic options. New advanced imaging techniques such as positron emission tomography-computed tomography PET-CT [ 11 ] and endobronchial ultrasound [ 12 ] allow refined lung cancer staging and can thus prevent futile thoracotomies.

New medical therapies such as targeted agents [ 13 , 14 ] prolong survival but may involve side-effects other than those traditionally known with chemotherapy.

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Modern radiotherapy techniques such as the integration of four-dimensional CT for planning intensity-modulated radiotherapy have improved the accuracy of irradiation delivery [ 15—17 ]. Surgery remains the best curative option in early-stage disease and is part of a multimodality approach for patients with resectable, locally advanced tumors [ 18 , 19 ]. Approval was obtained from the Ethics Committee of the University of Regensburg 31 March , reference number In addition, the study protocol was approved by local ethical committees according to the national requirements.

The study was registered with clinicaltrials.

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During phase I, a comprehensive list of QoL issues relevant to lung cancer patients was generated, using different sources of information. First, an extensive systematic literature search was carried out that covered clinical studies with the LC13 as an outcome measure [ 21 ]. Second, a total of 29 questionnaires on lung cancer and respiratory illnesses were analyzed [ 22—25 ]. Third, investigator brochures of new medications tested in international clinical trials on lung cancer patients were scrutinized for adverse and serious adverse events.

Fourth, nine health care professionals at the University Hospital Regensburg representing different disciplines pneumology, thoracic surgery, oncology, radiotherapy, nursing, and clinical psychology were invited to a 2-hour nominal group process [ 26 ] to generate issues that were important with regard to the therapy, symptoms, and experiences of lung cancer patients. Fifth, patients and health care providers responded to a comprehensive list of issues and rated their relevance and priority to be included in a QoL questionnaire for lung cancer patients.

In order to ensure uniform wording across different EORTC modules, items were recycled from the item bank [ 27 ] whenever possible. The provisional updated lung cancer module was pretested in a phase III study with the goal to assess the relevance and acceptance of the items and to find out whether any important issues were missing. Patients first filled in the QLQ-C30 and the updated provisional lung cancer module that comprised 48 items. Then patients were interviewed about their opinion regarding the updated module.

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Finally, patients answered open-ended questions asking whether any items should be omitted or whether any issues were missing or should be reformulated. Patients who did not meet all these inclusion criteria were excluded. Since the histological type of disease and the disease stage determine the choice of treatment and treatment in turn is mainly responsible for changes in QoL to the worse or better , main stratification criteria were the type of therapy and the timing of treatment.

The sample matrix specifies three main groups of the primary therapy: surgery, radio-chemotherapy, or targeted therapy. The singular use or combination of these therapies yielded nine subgroups Table 1. The time frames of QoL assessment were chosen so that symptoms and side-effects were likely to be present and detectable by means of the questionnaire. Table 1. Sample matrix: phase III study. Patients scored 1 point for each of the nine criteria that they fulfilled.

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An item was considered eligible for inclusion if six of the nine criteria were met. In addition to these quantitative criteria, we also considered qualitative statements by patients in the open interview and judgments by experts of the study group. Data from patient and health care provider interviews and questionnaires were analyzed using basic descriptive statistics: counts, percentages, means and SDs, medians, and ranges.

Patient ratings regarding relevance, comprehensiveness, and intrusiveness of the items were calculated for the entire sample of patients as well as for the therapeutic subgroups surgery, chemotherapy, radiotherapy, radiochemotherapy, and targeted therapy. The literature searches and the focus group resulted in a list of potentially relevant QoL issues that in a next step were rated by patients and health care providers from 7 countries Austria, Germany, Italy, Norway, Spain, Taiwan, and the UK.

An a priori defined set of threshold criteria were applied, and the empirical results were discussed within the study group. As a result, 53 issues were retained Table 2. Table 2. Quality-of-life issues as rated by patients and health care professionals in phase I. On the basis of the issue list, a provisional module was created. The provisional module also included an ad hoc scale on symptoms of patients who had undergone lung cancer surgery.

This scale had been developed and published outside the EORTC and had never been formally psychometrically validated [ 28 ]. Nevertheless, in terms of content, the items appeared useful for surgical patients, and the lead author granted permission to use the scale. In summary, the provisional module consisted of 48 items.

The number of items is slightly lower than the number of issues because of the redundancy of some issues e. Two hundred patients participated in this international multicenter study Table 3. Table 3. As can be seen in Table 4 , 27 items met the quantitative decision criterion of six points. Table 4. The decision score had a range from 0 to 9 maximum , and 6 was considered the threshold.

Included because items were rated relevant in the groups radiochemotherapy and targeted therapy. The following items were excluded: Have you felt loss of energy? Did you feel a sudden change of life because of your illness? Have you been afraid of losing your ability to move? Have you been afraid of shortness of breath?

Have you been afraid of pain? Pain medication: how much did it help?


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Have you felt uncertain about the future? Have you worried about what might happen towards the end of your life? Have you had memory loss? Has your disease or treatment affected your sex life for the worse? Have you had acne?

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Have you had unusual eyelash growth or unusual growth of hair in other parts of the body? Did the above-mentioned situation interfere with your daily activities? Have you had any pain in or around the scar? Have you had numbness in or around the scar? Did climatic changes affect the feeling of the scar? Has the scar interfered with your family life? Has the scar interfered with your social activities? What is your overall impression about the operation?

Most comments referred to the bundles of questions related either to cough, dyspnea, pain, and existential issues. In all instances, patients suggested to minimize the number of items. More than three patients missed aspects of religion and spirituality, positive aspects of life, family issues and satisfaction with care, and the patient—physician relationship. Other issues that were eventually mentioned were remorse of ever having smoked as well as radiotherapeutic and esophageal symptoms. Twenty-seven items met the quantitative decision criterion of six points.

Two additional items that scored 5 in the overall sample received more favorable ratings in subgroup analyses radiotherapy and targeted therapy and were thus included Table 4. A total of 19 items were excluded.


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  • Eleven items were eliminated because they were redundant, five items failed the quantitative criteria, one item was difficult to understand, and one item had too many missing responses. One item was not considered because it referred to overall satisfaction with surgery using a seven-step response scale. In summary, most decisions to exclude items were guided by the principle to avoid redundancies and keep the length of the module acceptable. The final updated phase III module contains a total of 29 items, 24 general and 5 surgery specific. Table 5. These preparatory phases resulted in a provisional item module.

    The goal of the international, cross-cultural, multicenter phase III study was to test this provisional module regarding relevance, acceptability, comprehensibility, and completeness.