title: POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.
abstract: 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. 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.
  
  
  
  The 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.
  
  
  
  The 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.
  
  
  
  ClinicalTrials.gov NCT02055508 (Date: December 12, 2013).
authors.affiliation: Working Group Exercise Oncology, Division of Medical Oncology, National Center for Tumor Diseases (NCT) and University Clinic Heidelberg, Heidelberg, Germany. joachim.wiskemann@nct-heidelberg.de.|National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany. joachim.wiskemann@nct-heidelberg.de.
authors.forename: Joachim
authors.identifier: 0000-0002-5971-5436
authors.initials: J
authors.lastname: Wiskemann
authors.affiliation: Clinic for Thoracic Diseases, Department of Oncology, Thoraxklinik am Universitätsklinikum, Heidelberg, Germany.|Clinic for Thoracic Diseases, Department of Pneumology and Intensive Care Unit, Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg, Germany.|Translational Lung Research Center Heidelberg (TLRC), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: Simone
authors.initials: S
authors.lastname: Hummler
authors.affiliation: National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Diepold
authors.affiliation: Immune Monitoring Unit (G808), National Center for Tumor Diseases (NCT) and German Cancer Research Center (DKFZ), Heidelberg, Germany.|CCU Neuroimmunology and Brain Tumor Immunology, National Center for Tumor Diseases, (NCT) and German Cancer Research Center (DKFZ), Heidelberg, Germany.
authors.forename: Melanie
authors.initials: M
authors.lastname: Keil
authors.affiliation: National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Abel
authors.affiliation: National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany.
authors.forename: Karen
authors.initials: K
authors.lastname: Steindorf
authors.affiliation: National Center for Tumor Diseases (NCT) and German Cancer Research Center, Heidelberg, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Beckhove
authors.affiliation: Huntsman Cancer Institute, Salt Lake City, Utah, USA.
authors.forename: Cornelia M
authors.initials: CM
authors.lastname: Ulrich
authors.affiliation: Clinic for Thoracic Diseases, Department of Oncology, Thoraxklinik am Universitätsklinikum, Heidelberg, Germany.|Translational Lung Research Center Heidelberg (TLRC), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Steins
authors.affiliation: Clinic for Thoracic Diseases, Department of Oncology, Thoraxklinik am Universitätsklinikum, Heidelberg, Germany.|Translational Lung Research Center Heidelberg (TLRC), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
mesh_terms: D000328:Adult; D000368:Aged; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010166:Palliative Care / Q000379:methods*; D010809:Physical Fitness / Q000502:physiology; D011788:Quality of Life; D055070:Resistance Training; D011795:Surveys and Questionnaires
keywords: Care management phone calls; Fatigue; Lung cancer; Palliative treatment; Physical exercise; Quality of life