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Backround: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used., Methods: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors., Results: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment., Conclusions: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Background: The purpose of this prospective study was to evaluate whether a relationship exists between malnutrition (> or =10% weight loss) and health-related quality of life (HRQL) in patients with head and neck cancer and whether weight loss can be predicted with HRQL questionnaires., Methods: Weight and HRQL were monitored in 49 patients. HRQL was assessed longitudinally, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), the EORTC Head and Neck Cancer module (QLQ-H&N35), and the Hospital Anxiety and Depression Scale (HADS)., Results: At diagnosis, those patients who had a weight loss greater than 10% (n = 20) after treatment scored significantly worse on 15 of 28 HRQL variables than did patients who lost less (n = 29). The largest difference (Delta > or =20) was found for role functioning, fatigue, loss of appetite, global quality of life, sticky saliva, and swallowing. Differences in HRQL persisted even after 3 years. The fatigue scale was the only significant predictor of weight loss (p = .005) at diagnosis., Conclusions: Patients with head and neck cancer who are at risk of severe weight loss developing during treatment may be detected with the aid of HRQL questionnaires at diagnosis.

Background: A longitudinal, prospective, case-control study evaluated if a psychosocial support program improved health-related quality of life (HRQL) in head and neck (H&N) cancer patients., Methods: One hundred forty-four H&N cancer patients were included: 52 study patients and 92 controls. The study group met the support team repeatedly throughout the first year after diagnosis. HRQL was assessed three times during the first year and after 3 years using the EORTC QLQ-C30, EORTC QLQ-H&N35, and HADS., Results: A few statistically significant differences were found, all favoring the controls. Controls reported better global quality of life after 1 year and felt less ill after 3 years. Depression and treatment-related side effects were prevalent in both groups., Conclusions: Our psychosocial support program did not improve HRQL in H&N cancer patients. Its effectiveness may be improved by evaluating and actively integrating HRQL assessments during the program, thereby enabling rapid and adequate symptomatic treatment and/or psychologic intervention., (Copyright 2003 Wiley Periodicals, Inc. Head Neck 25: 576-584, 2003)