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The purpose of the present study was twofold: first, to describe changes of Health-Related Quality of Life (HRQoL) during the adjuvant treatment among postmenopausal women with breast cancer; second, in the same population to identify the best predictors of Overall Quality of Life (QoL) after treatment, from perceived functioning, symptoms, emotional distress and clinical/demographic variables measured at baseline. The study group was 150 women (> or = 55 years of age) scheduled for adjuvant chemotherapy (CT, n=75) or radiotherapy (RT, n=75). They were examined before (baseline), during and after completing the treatment. Data about QoL, perceived functioning, symptoms and emotional distress were collected with the European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30, BR23 and Hospital Anxiety and Depression Scale (HADS) questionnaires. The general finding was that the adjuvant treatments were associated with decrease in overall QoL, physical and role functioning, anxiety and body image, as well as with increase in fatigue, dyspnoea, pain, nausea/vomiting, constipation and systemic therapy side effects measured over time. For women receiving CT, better emotional functioning and less pain at baseline predicted better overall QoL at the end of the treatment. For women receiving RT, better physical and emotional functioning, less breast symptoms and lower tumour stage at baseline predicted better overall QoL at the end of the treatment.
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PMID:Health-related quality of life during adjuvant treatment for breast cancer among postmenopausal women. 1834 97

To identify the impact of multiple symptoms and their co-occurrence on health-related quality of life (HRQOL) dimensions and performance status (PS), 115 outpatients with cancer, who were not receiving active cancer treatment and were recruited from a university hospital in Sao Paulo, Brazil completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, the Beck Depression Inventory, and the Brief Pain Inventory. Karnofsky Performance Status scores also were completed. Application of TwoStep Cluster analysis resulted in two distinct patient subgroups based on 113 patient experiences with pain, depression, fatigue, insomnia, constipation, lack of appetite, dyspnea, nausea, vomiting, and diarrhea. One group had multiple and severe symptom subgroup and another had less symptoms and with lower severity. Multiple and severe symptoms had worse PS, role functioning, and physical, emotional, cognitive, social, and overall HRQOL. Multiple and severe symptom subgroup was also six times as likely as lower severity to have poor role functioning; five times more likely to have poor emotional; four times more likely to have poor PS, physical, and overall HRQOL; and three times as likely to have poor cognitive and social HRQOL, independent of gender, age, level of education, and economic condition. Classification and Regression Tree analyses were undertaken to identify which co-occurring symptoms would best determine reduction in HRQOL and PS. Pain and fatigue were identified as indicators of reduction on physical HRQOL and PS. Fatigue and insomnia were associated with reduction in cognitive; depression and pain in social; and fatigue and constipation in role functioning. Only depression was associated with reduction in overall HRQOL. These data demonstrate that there is a synergic effect among distinct cancer symptoms that result in reduction in HRQOL dimensions and PS.
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PMID:Impact of cancer-related symptom synergisms on health-related quality of life and performance status. 1836 59

Breast cancer, the commonest malignancy in women, is now the most common cancer in Nigeria, but little is known about the quality of life (QOL) of Nigerian women breast cancer survivors and the predictive factors that may influence their QOL. Health-related QOL (HRQOL) was evaluated in 35 Nigerian women receiving radiotherapy for breast cancer at the University College Hospital, Ibadan by using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ - C30 version 3). Linear regression procedures were used to evaluate the association of HRQOL outcomes with medical and socio-demographic factors. Physical functioning (PF), Emotional functioning (EF) and Cognitive functioning (CF) scores were above average (76.9 +/- 20.6, 61.9 +/- 30.3 and 60.0 +/- 32.1 respectively) while Role functioning (RF) and Social functioning (SF) scores were below average (46.2 +/- 36.6 and 40.9 +/- 42.8 respectively). High symptom scale scores were recorded for fatigue, pain and financial difficulties (52.7 +/- 32.8, 59.1 +/- 34.4 and 71.4 +/- 38.8 respectively). Age had no significant influence on any of the functional and symptom scale scores as well as the overall QOL. The overall QOL was significantly related to PF, CF and SF. It was also significantly and inversely related to the scores of fatigue, nausea and vomitng, pain, insomnia and financial difficulty. The findings of this study provide important information on QOL and their correlates among Nigerian women undergoing radiotherapy for breast cancer and are helpful in developing treatment strategies accordingly.
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PMID:Health related quality of life and its determinants in Nigerian breast cancer patients. 1839 66

Recently, a few studies reported that fatigue was a predominant contributor to patient-perceived overall QoL in patients with different types of cancer in a relatively early stage of disease. In the present study, we aimed to investigate whether fatigue is also a major contributor to overall QoL in preterminal cancer patients. Ninety-eight preterminal cancer patients, mainly lung (44%) and gastrointestinal cancer (25%), with an estimated life expectancy of 1-6 months were included. QoL domains as well as overall QoL were measured using the EORTC QLQ-C30 questionnaire. Data were analysed by Pearson's correlations and multivariate modelling. Fatigue showed the strongest correlation with overall QoL (r = -0.63, p < 0.001), followed in decreasing order by role functioning (r = 0.53), physical functioning (r = 0.47), social functioning (r = 0.44), nausea (r = -0.37), cognitive functioning (r = 0.33), appetite loss (r = -0.31), dyspnea (r = -0.26) and emotional functioning (r = 0.24). Multivariate analysis confirmed that the fatigue scale paid by far the highest individual contribution to overall QoL (standardized regression coefficient (SRC): -0.41, p = 0.002), followed by social functioning (SRC: 0.18, p = 0.05). None of the other domains or symptom scales contributed independently to overall QoL. Our results clearly demonstrate that, in preterminal cancer patients, fatigue is a major contributor of overall QoL, corroborating reports in cancer patients in earlier disease stages.
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PMID:Determinants of overall quality of life in preterminal cancer patients. 1841 47

Patients with cancer frequently suffer a deteriorated quality of life and this is an important factor in the therapeutic decision. The correlation between quality of life and malnutrition seems obvious and bidirectional. The aim of our study was to describe the global quality of life and its various dimensions in patients with cancer, as a function of the nutritional status. A transversal observational study was performed in wards in hospitals in Clermont-Ferrand and Saint Etienne on 907 patients. The EORTC questionnaire, QLQ-C30, was used to assess the quality of life. The mean global quality of life score was 48.8 for patients who had a weight loss of more than 10% since the beginning of their illness, compared with 62.8 for the other patients (p<0.001). A significant association with weight was observed for the main dimensions of the quality of life: physical, functional, cognitive, social, fatigue, nausea, pain, loss of appetite, constipation and diarrhoea. This strong relation between quality of life and weight loss shows the importance of dietary management in patients with cancer.
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PMID:Relationship between nutritional status and quality of life in patients with cancer. 1846 87

PURPOSE To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non-small-cell lung cancer NSCLC. PATIENTS AND METHODS Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m(2) plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m(2) on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles. The primary end point was health-related quality of life (HRQoL) defined as global quality of life, nausea/vomiting, dyspnea, and fatigue reported on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the lung cancer-specific module LC13 during the first 20 weeks. Secondary end points were overall survival and toxicity. Results Four hundred thirty-six eligible patients were enrolled from April 2005 to July 2006. Patients who completed the baseline questionnaire were analyzed for HRQoL (n = 427), and those who received > or = one cycle of chemotherapy were analyzed for toxicity (n = 423). Compliance of HRQoL questionnaires was 87%. There were no significant differences for the primary HRQoL end points or in overall survival between the two treatment arms (pemetrexed/carboplatin, 7.3 months; gemcitabine/carboplatin, 7.0 months; P = .63). The patients who received gemcitabine/carboplatin had more grade 3 to 4 hematologic toxicity than patients who received pemetrexed/carboplatin, including leukopenia (46% v 23%, respectively; P < .001), neutropenia (51% v 40%, respectively; P = .024), and thrombocytopenia (56% v 24%, respectively; P < .001). More patients on the gemcitabine/carboplatin arm received transfusions of RBCs and platelets, whereas the frequencies of neutropenic infections and thrombocytopenic bleedings were similar on both arms. CONCLUSION Pemetrexed/carboplatin provides similar HRQoL and survival when compared with gemcitabine/carboplatin with less hematologic toxicity and less need for supportive care.
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PMID:Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. 1943 83

This multicenter study was intended to validate the French version of the M. D. Anderson Symptom Inventory (MDASI-Fr) in French cancer patients (n=162) with solid tumors or hematological malignancies. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used as a part of the validation. Factor analysis showed three underlying constructs for symptom items: general symptoms (pain, fatigue, disturbed sleep, shortness of breath, drowsiness, dry mouth, and numbness or tingling items); emotional and cognitive components (distress, sadness, and remembering items); and a gastrointestinal component (nausea, vomiting, and lack of appetite items), with Cronbach's alphas of 0.79, 0.73, and 0.71, respectively. Convergent validity was established by comparing MDASI-Fr items with the EORTC QLQ-C30 scale and the Brief Pain Inventory (BPI). Overall, the 19-item MDASI-Fr score correlated well with the QLQ-C30 global health status, and the pain item of the MDASI-Fr was highly correlated with the short form of the BPI. The most prevalent symptoms were fatigue, distress, dry mouth, and pain. Twenty-five percent of patients reported moderate or severe pain (numeric rating scale >4 on 0-10 severity ratings). Physician ratings of global change on a second visit were significantly associated with changes in patient ratings on the MDASI-Fr, supporting the sensitivity of the measure. Symptoms interfered most with work and general activity. The MDASI-Fr is a valid and reliable tool for measuring symptom severity and interference in French cancer patients.
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PMID:Cancer-related symptom assessment in France: validation of the French M. D. Anderson Symptom Inventory. 2041 59

The treatment of primary breast cancer usually consists of surgery often followed by adjuvant therapy (radiotherapy, chemotherapy, hormonal treatment, etc.) to reduce the risk of recurrence. The cancer diagnosis and the treatments may have significant impact on the patients' quality of life. This thesis deals with scientific aspects and clinical results of a study aimed at assessing the impact of breast cancer (and its treatment) on the patients' quality of life. Studies such as this assessing the problems and symptoms experienced by the patients are often referred to as health-related quality of life (HRQL) research. HRQL research deals with subjective experiences and raises challenging, scientific questions. Therefore, much attention was directed towards methodological issues in this clinically motivated project. The study was a prospective, longitudinal, questionnaire-based investigation of women with newly diagnosed breast cancer registered in the Danish Breast Cancer Co-operative Group's DBCG 89 Program. The patients were sub-divided into low-risk and high-risk patients. High-risk patients were offered randomisation in one of three randomised adjuvant therapy trials involving chemotherapy, ovarian ablation, and endocrine therapy. After a literature study and interviews with breast cancer patients, a questionnaire was composed that included two widely used standard questionnaires (EORTC QLQ-C30 and Hospital Anxiety and Depression (HAD) Scale) and a DBCG 89 Questionnaire developed for this study. A total of 1,898 eligible patients were invited by post to participate in the study involving six assessments over a 2-year period, and 1,713 patients (90%) completed the first questionnaire. Furthermore, a questionnaire was sent to 872 women selected at random from the general population; 608 (70%) responded. The multi-item scales of the two standard questionnaires were analysed for so-called differential item functioning (DIF) in order to investigate whether the (summary) scale scores were adequate representations of the information obtained by the individual items. The DIF analyses identified a number of cases of DIF, which, among other things, contributed to detection of possible problems in the HAD Scale. It was concluded that DIF analyses are relevant when important analyses based on multi-item scales are made. A new way to evaluate the validity of questionnaires was developed. The results from questionnaires completed by patients were compared against results from open ended interviews with the same patients rated by observers. The idea was that if results were similar, the patients had then probably understood and completed the questionnaire items as intended. On the other hand, if results from self-assessment and interviews deviated, misunderstandings or other errors might have taken place, and the study would give insight into possible problems. Of 57 breast cancer patients, 46 (81%) were successfully interviewed. In general, the agreement between patient-completed questionnaires and interviews was excellent, indicating very good validity. The median weighted kappa for the EORTC QLQ-C30 was 0.85 (range 0.49-1.00); it was 0.79 (range 0.65-0.95) for the HAD Scale, and 0.92 (range 0.51-1.00) for the DBCG 89 Questionnaire. However, the study identified a mechanism called selective reporting, which may affect results from most HRQL questionnaires: in order to provide correct and useful answers some patients do not report symptoms they believe are irrelevant to the study, e.g., symptoms unrelated to cancer. This mechanism may lead to bias if results from patients are compared to results from populations reporting their symptoms more completely, e.g., general population samples. In contrast, this mechanism has little importance when results from different sub-groups of cancer patients are compared. In this study multiple variables were assessed at multiple points in time and we did not have a priori hypotheses for all these potential comparisons. Therefore, a staff survey involving experienced doctors and nurses was conducted in order to generate hypotheses that could be tested in the data from patients. We contacted 46 health care professionals and 36 (78%) responded. Overall, the staff survey did not prove very useful for the intended purpose. The main reason for this was probably that the health care professionals had limited insight into the patients' HRQL. A different approach to the problem of multiple hypothesis testing proved more useful. Hypotheses generated from the initial literature review were tested in the comparison of patients in chemotherapy against patients not in chemotherapy. The study of women selected at random from the general population showed that these women experienced a considerable degree of "morbidity" according to all three questionnaires. This shows that symptoms and problems reported by cancer patients may have causes other than cancer, and thus constitutes a good justification for the use of data from general population studies when interpreting data from cancer patients. The levels of anxiety and depression of low-risk breast cancer patients were found to be lower than those from the general population sample. After careful consideration we concluded that this finding was probably incorrect. The most important explanations were thought to be the wording of some HAD Scale items as well as two mechanisms that are not specific to the HAD Scale, the "selective reporting mechanism" found in the validation study, and the response-shift problem. These findings indicate - in contrast to the conclusion above - that the comparability of HRQL data from cancer patients and general population data must be questioned. However, as this is the first study to raise the problem, this issue needs further investigation. Based on the initial literature review and interviews we hypothesised that 30 different HRQL issues would be impaired in patients undergoing CMF chemotherapy compared to patients not in chemotherapy; 23 of these hypotheses were confirmed. In addition, our study and other research suggest that other HRQL aspects may also be affected by chemotherapy. Thus, there is considerable evidence that patients in chemotherapy may experience effects on a wide spectrum of HRQL issues. Most other studies have assessed surprisingly few of the HRQL issues shown in our study to be impaired in patients receiving chemotherapy. Similarly, current review articles on HRQL effects of adjuvant chemotherapy mention only relatively few of these topics. Concerning HRQL after the treatment period, our main finding was that many symptoms and problems had declined or disappeared, but some persisted: anticipatory nausea, weight gain, endocrine effects (e.g., hot flushes/sweats, irregular bleedings/amenorrhea, vaginal dryness), disturbed sleep, and sexual dysfunction. These findings are in agreement with the literature. The staff study showed that experienced physicians and nurses did not expect many of the "scientifically well documented" consequences of chemotherapy. Taken together, our findings suggest that information to patients about chemotherapy should be more comprehensive than that which has been practised in most places. When compared against ovarian ablation, chemotherapy was associated with more impact on HRQL during the treatment period; only hot flushes/sweats were more pronounced in the ovarian ablation group. Thus, from an overall "HRQL perspective" ovarian ablation or suppression may be preferable. However, younger women may preserve their premenopausal status (including fertility) by having chemotherapy, and this may be an argument for chemotherapy or for temporary ovarian ablation via goserelin, rather than permanent ovarian ablation. Furthermore, while ovarian ablation/suppression may be preferable because of less impairment of HRQL, contemporary chemotherapeutic regimens may be more effective. These results indicate that for some patients, the HRQL data and results on treatment efficiency may be in conflict. There is no simple, universally correct solution to this dilemma. More research into patients' views and expectations to the health-care system in cases where medical decision-making involves complex trade-offs between treatment efficiency and HRQL issues is needed. Contrary to expectations, the analyses showed that fatigue and emotional function predicted the risk of recurrence and death independently of biological and clinical prognostic variables. In multivariate Cox regression analyses patients who were more fatigued or had poorer emotional function had a worse prognosis. These results are consistent with one small study, but are inconsistent with five similar studies in patients with primary breast cancer, which found no such associations. The reasons for these important differences are currently unknown. In conclusion, this study consisted of methodological and clinical investigations of HRQL in primary breast cancer patients. The initial questionnaire development resulted in a combination of questionnaires that was more comprehensive than in other similar studies. The results of the methodological studies generally supported the validity of the questionnaires but also gave important insights into potential scientific problems that are probably not restricted to the present study. These insights helped to prevent misinterpretations of the clinical data. The study provided the most detailed description of HRQL during and after breast cancer adjuvant chemotherapy to date, and compared results of chemotherapy against ovarian ablation. It also provided controversial results concerning the prognostic value of HRQL data. The combination of a large empirical study and several methodological sub-studies thus proved useful and gave new results.
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PMID:Health-related quality of life in early breast cancer. 2081 24

Curative treatment of esophageal cancer with definitive or preoperative high-dose chemoradiotherapy inflicts a major strain on the patients with potentially severe physical, emotional, and social consequences. The aim of this study was to assess various aspects of quality of life and fatigue in long-term survivors following such a treatment. Patients undergoing a potentially curative treatment between 1996 and 2007, and still alive (n= 41) completed quality of life questionnaires of the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and esophageal cancer module (QLQ-OES18). Twenty patients were treated by surgery alone, and 21 patients were scheduled for high-dose chemoradiotherapy followed by surgery. Five of those patients did not undergo planned surgery. Preoperative chemoradiotherapy consisted of three courses of chemotherapy, cisplatin 100 mg/m(2) and 5-fluorouracil 5000 mg/m(2) in each course and concomitant radiotherapy of a median dose 66 Gy. Quality of life in esophageal cancer patients receiving high-dose chemoradiotherapy was compared with that for esophageal cancer patients who received only surgery, head and neck cancer patients, laryngectomized patients, and a random sample of the general Norwegian population. Esophageal cancer patients treated by high-dose chemoradiotherapy had significantly worse global quality of life as reflected by almost all functional scales and higher fatigue compared with esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. There were no significant differences in quality of life between the esophageal cancer patients receiving high-dose chemoradiotherapy and the laryngectomy patients. Further, the esophageal cancer patients receiving high-dose chemoradiotherapy had higher intensity of other symptoms like general pain, insomnia, nausea/vomiting, diarrhea, and constipation compared with the esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. High-dose chemoradiotherapy with cisplatin and 5-fluorouracil had a considerable negative long-term effect on global quality of life in patients with resectable esophageal cancer. Fatigue was a prominent long-lasting symptom in these patients.
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PMID:Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer. 2081

The purposes of this study were to investigate the prevalence of anticipatory nausea (AN), its associated factors, and its impact on quality of life (QOL) among ambulatory cancer patients receiving chemotherapy. Patients were randomly selected to participate in this study, and were asked to complete the Morrow Assessment of Nausea and Emesis scale, the Hospital Anxiety and Depression Scale, the Short-form Supportive Care Needs Survey questionnaire, and the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. Complete data were available for 214 patients. A total of 10.3% of the patients experienced very mild to severe AN. The presence of AN was significantly associated with most domains of the investigated patients' outcome, including psychological distress and perceived needs, with the exception of the health system and information domain of patients' needs, and the physical functioning domain of QOL. Anticipatory nausea was also associated with QOL even after adjustments for age, sex, performance status, and psychological distress. The prevalence of AN in ambulatory cancer patients who receive chemotherapy may not be as high as previously reported. However, given its potentially significant impact on relevant outcome, including QOL, AN should not be neglected in current clinical oncology practice. (Cancer Sci 2010; 101: 2596-2660).
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PMID:Anticipatory nausea among ambulatory cancer patients undergoing chemotherapy: prevalence, associated factors, and impact on quality of life. 2094 20


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