Abstract
BackgroundPatients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting.Methods/designThe POSITIVE study is a randomized, controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life, physical performance and immune function in advanced, non-operable lung cancer patients. 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg, enrolment begun in November 2013. Main inclusion criterion is histologically confirmed NSCLC (stage IIIa, IIIb, IV) or SCLC (Limited Disease-SCLC, Extensive Disease-SCLC) not amenable to surgery. Patients are randomized into two groups. Both groups receive weekly care management phone calls (CMPCs) with the goal to assess symptoms and side effects. Additionally, one group receives a combined resistance and endurance training (3x/week). Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer (FACT-L, subcategory Physical Well-Being) and General Fatigue measured by the Multidimensional Fatigue Inventory (MFI-20). Secondary endpoints are physical performance (maximal voluntary isometric contraction, 6-min walk distance), psychosocial (depression and anxiety) and immunological parameters and overall survival.DiscussionThe aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages. Analysis of various outcomes (such as quality of life, physical performance, self-efficacy, psychosocial and immunological parameters) will contribute to a better understanding of the potential of exercise in advanced lung cancer patients. In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life.Trial registrationClinicalTrials.gov NCT02055508 (Date: December 12, 2013)
Highlights
Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease
As expected the results showed that advanced lung cancer patients experience muscular weakness, especially in the lower extremities, lower endurance performance and decreased quality of life compared to a healthy reference group [24]
Primary endpoints are (1) quality of life as measured by the Functional assessment of Cancer TherapyLung (FACT-L) questionnaire, subcategory Physical Well-Being and (2) general fatigue measured by the Multidimensional Fatigue Inventory (MFI-20)
Summary
Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. Advanced lung cancer patients often experience multidimensional impairments affecting quality of life during their course of disease [5]. Socioeconomic problems arise and patients lose their social and professional integration They are facing physical fragility and in many cases end-of-life situations [6]. A study in a representative sample of advanced cancer patients (n = 1630) in Denmark observed that lung cancer patients had exacerbated symptom burden (e.g. fatigue, dyspnea, pain, appetite loss), and presented with reduced physical and emotional function and quality of life, when compared with other cancer diagnoses like head and neck, gynecological, prostate, breast, gastrointestinal or bladder tumors [5]. Other investigations showed that patients with advanced lung cancer have specific problems such as coughing, shortness of breath, anorexia, and insomnia that need to be addressed [7,8,9,10]
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