Improving Sleep in Lung Cancer Patients: A Trial of Aerobic Exercise and Tai-chi

To assess the change of quality of sleep, the Chinese version of the Pittsburgh Sleep Quality Index, from baseline at 16-week and 1 year

To measure compliance to exercise all participants will be measured for their level of physical activity in daily living. Physical activity will be quantified with a non-invasive small-size wrist-worn piezoelectric accelerometer (Actigraph; Ambulatory Monitoring Inc., New York). Actigraphy has been shown to provide valid assessments of physical activity. The user-defined time interval for the count of wrist accelerations is 1 min. Patients will be asked to wear the actigraph for at least 3 consecutive 24-hour spans. Each patient will keep a diary for times of rising and retiring.

We will measure circadian rhythms using biomarkers that have been linked to survival of cancer patients, cortisol rhythms will be measured using saliva samples collected before and after intervention. The cortisol levels will be measured using enzyme-linked immunosorbent assay (ELISA) kits. The saliva will be collected using Salivettes at following time points: 0.5 hour, 4 hour, 8 hour and 12 hour after habitual wake time (referred as circadian time).

We will measure circadian rhythms using biomarkers that have been linked to survival of cancer patients, melatonin rhythms will be measured using saliva samples collected before and after intervention. The melatonin levels will be measured using enzyme-linked immunosorbent assay (ELISA) kits. The saliva will be collected using Salivettes at following time points: 0.5 hour, 4 hour, 8 hour and 12 hour after habitual wake time (referred as circadian time).

Cardio-respiratory fitness shall be evaluated using the 6-minute walking test (6MWT). The 6MWT has been widely used to assess cardio-respiratory fitness in lung cancer patients [28-30]. The 6MWT requires participants to walk on an even and flat surface between two cones set 30m apart, with the object being the participant walking as far as possible within the 6 minutes period (if participant cannot continue for the 6 minutes, the test will end). The walking test is measured in units of meters walked at the end of the 6 minutes.

Physical fitness will a be assessed using the Get Active Questionnaire (GAQ). The GAQ assesses if participants are safe to participate in the interventions and ensures if participants can perform the exercises within the intervention.

This test evaluates participants' agility.

This test evaluates participants' muscle strength.

This test evaluates participants' balance.

For each participant, 10 ml of peripheral blood will be collected before and after intervention in intervention groups, as well as in control group at the same time points, for some immune functional studies. The peripheral blood mononuclear cells are isolated for measurements of immune functions. Immune functions will be analyzed by cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation.

Health related QoL is an important outcome for lung cancer patients and plays an important impact on prognosis. The Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). It will be evaluated by three parts, global score, symptom score and functional score with the range of 0-100. Higher score in global and functional aspects denote better quality of life while lower score in symptom aspects denotes better quality of life.

Health related QoL is an important outcome for lung cancer patients and plays an important impact on prognosis. The Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire corresponding lung cancer-specific module (QLQ-LC13) shall be used as measurements of QoL. Lower score denotes better quality of life. The range of score is 0-100.

To evaluate psychological distress the Hospital Anxiety and Depression Score (HADS) will be used. The HADS comprises seven items each for anxiety and depression. Each item of the anxiety subscale and the depression subscale was scored on a 4-point scale. This scale is a reliable tool, and is widely used to assess patients with cancer.

Fatigue will be measured by the Chinese version of the Brief Fatigue Inventory (BFI). The BFI was developed to measure fatigue in cancer patients. It consists of 9 items with each item scored on a 0-10 scale. The BFI measures patients' fatigue when symptoms are at their worst, least, usual and currently during the normal waking hours, with 0 indicating no fatigue, and 10 being fatigue as bad as one can imagine. Other items include fatigues interaction with patients' general activity, mood, waking ability, normal work (includes both work outside the home and housework), relations with other people, ability to think clearly, and enjoyment of life. The interference is measured with 0 being does not interfere, and 10 being completely interferes.

Actigraph will serve as an objective measure for assessing sleep parameters, such as sleep efficiency, total sleep time.

Frailty will be measured by weight loss, exhaustion, low physical activity, slowness and weakness.

One-year relative survival rate will be retrieved from patients' medical record.