Grutsch et al. BMC Cancer 2011, 11:193 http://www.biomedcentral.com/1471-2407/11/193 mood, and increased anxiety; daytime fatigue and lethargy; and anorexia, early satiety, and diminished taste sensation [15-21]. The occurrence of these sickness behaviors among individuals suffering circadian disrup- tion strongly suggests that a disrupted circadian organi- zation adversely affects a patient’s quality of life. Lung cancer is the most prevalent lethal cancer in the devel- oped and developing world. However, there have been few investigations on the relationship between lung can- cer patients’ circadian organization and their quality of life [10,15]. Linking changes in a patients’ circadian organization to their quality of life is a complicated process. Quality of life is measured using a diverse assortment of out- comes that range across physical, psychological, social, and spiritual domains. Furthermore, for each assessed quality of life category there are a variety of different instruments. Physical domain assessment may measure symptoms, or the patient’s ability to meet the challenges of daily life, or adjustment to illness [22]. Quality of life is, thereby, a multidimensional concept, within which each specific category has a range of unique attributes. Wilson and Cleary [23] have developed a quality of life model that expresses the relevant logical connections among several quality of life measurements along a sequential pathway. This pathway establishes that phy- siological disturbances produce symptoms in patients that change their functional health, which in turn affects the patients’ perceptions of their general health, which in turn contributes directly to their perceptions of their overall quality of life. We measured circadian organization non-invasively using wrist actigraphs [24-28]. We also implemented the EORTC QLQ-C30 to measure the existence and inten- sity of the patient’s symptoms (symptom status) as well as the patient’s perception of his or her functional health [29,30]. We also utilized the Ferrans/Powers Quality of Life Index (QLI) to measure the patient’s level of satisfaction with how well their current life achieves an acceptable level of well being [22,31]. Methods Patients Patients participating in this investigation were recruited for a clinical trial that was conducted concurrently at Cancer Treatment Centers of America® (CTCA) at Midwestern Regional Medical Center (MRMC) in Zion, Illinois and the WJB Dorn Veterans Medical Center (VAMC) in Columbia, South Carolina from June 2002 to April 2006. Patients between the ages of 18 and 80 who had a pathologically confirmed diagnosis of stage III or IV non-small cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) perfor- mance status of 0, 1, or 2 were eligible. Untreated Page 2 of 13 patients and patients who had failed one prior che- motherapy treatment regimen were eligible. All patients signed an Informed Consent indicating that they were aware of the investigational nature of the study. The Institutional Review Boards at MRMC and VAMC approved the study. This current report is based only upon baseline data obtained at initial enrollment. Control Subjects Our control database for actigraphic parameters is com- prised of 3- to 7-day actigraphy measurements from 35 adults, aged 20 to 50 years, each having no known dis- ease (Action-W2 database, AMI, NY, USA). EORTC QLQ-C30 Reference Population data is from a survey of 1,313 newly diagnosed lung cancer patients with stage III and IV disease,32 while the EORTC QLQ-C30 Gen- eral Population data is from a survey of 1,965 randomly selected subjects in Norway aged eighteen to ninety- three years [33]. Ferrans/Powers QLI Health/Function- ing General Population data is taken from 339 subjects, drawn randomly from a telephone directory represent- ing urban, suburban, and rural areas in the Midwestern United States, who completed the QLI questionnaire (C. Ferrans, Feb 2009). Protocol Summary All patients agreed to complete their baseline quality of life questionnaires before undergoing their initial che- motherapy treatment cycle for this trial. At MRMC, actigraphy was performed in the inpatient setting imme- diately before (24-48 hours) and during their first che- motherapy cycle. VAMC actigraphy was obtained in the patients’ domestic setting, prior to their initial cycle of chemotherapy. EORTC QLQ-C30 and LC-13 The thirty question European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the thirteen question Lung Cancer Questionnaire (LC-13), were developed by clini- cal trialists to measure lung cancer patients’ ability to fulfill the routine activities of daily life.29 On the EORTC QLQ-C30, five function domains are used to measure physical, role, emotional, social, and cognitive functions. In addition, the EORTC QLQ-C30 measures the following symptom items; fatigue, nausea/vomiting, loss of appetite, pain, dyspnoea, insomnia, and financial. On the LC-13, has both multi-item and single-item measures of lung cancer associated symptoms. Six of the questions measure the four lung cancer associated symptoms items: coughing, haemoptysis, dyspnoea and pain. The other questions measure the side-effects from conventional chemo- and radiotherapy: hair loss, neuro- pathy, sore mouth and dysphagia. The possible scores