title: Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.
abstract: BACKGROUND
  The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time.
  
  
  METHODS
  We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance.
  
  
  CONCLUSIONS
  As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.
authors: Department of Oncology, Cruces University Hospital, Basque Health Service (Osakidetza), Barakaldo, Bizkaia, Spain. AINTZANE.SANCHOGUTIERREZ@osakidetza.net.
authors: Aintzane
authors: A
authors: Sancho
authors: Department of Oncology, Cruces University Hospital, Basque Health Service (Osakidetza), Barakaldo, Bizkaia, Spain. SERGIO.CARRERAREVILLA@osakidetza.net.
authors: Sergio
authors: S
authors: Carrera
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. MARIASOLEDAD.ARIETALEANIZBEASCOASARABIA@osakidetza.net.
authors: Marisol
authors: M
authors: Arietaleanizbeascoa
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. VERONICA.ARCE@osakidetza.net.
authors: Veronica
authors: V
authors: Arce
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. NERE.MANDIZABALGALLASTEGUI@osakidetza.net.
authors: Nere Mendizabal
authors: NM
authors: Gallastegui
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. ANNA.GINEMARCH@osakidetza.net.
authors: Anna
authors: A
authors: Giné March
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. Aitor.SanzGuinea@osakidetza.net.
authors: Aitor
authors: A
authors: Sanz-Guinea
authors: Luxana-Barakaldo Health Centre, Basque Health Service (Osakidetza), Barakaldo, Bizkaia, Spain. MARIAARACELI.ESKISABELGONI@osakidetza.net.
authors: Araceli
authors: A
authors: Eskisabel
authors: Basauri-Ariz. Health Centre, Basque Health Service (Osakidetza), Basauri, Bizkaia, Spain. ANAMARIA.LOPEZRODRIGUEZ@osakidetza.net.
authors: Ana Lopez
authors: AL
authors: Rodriguez
authors: Algorta-Bidezabal Health Centre, Basque Health Service (Osakidetza), Getxo, Bizkaia, Spain. ROSAAMAIA.MARTINSANTIDRIAN@osakidetza.net.
authors: Rosa A
authors: RA
authors: Martín
authors: Department of Oncology, Cruces University Hospital, Basque Health Service (Osakidetza), Barakaldo, Bizkaia, Spain. GUILLERMO.LOPEZVIVANCO@osakidetza.net.
authors: Guillermo
authors: G
authors: Lopez-Vivanco
authors: Primary Care Research Unit of Bizkaia, Basque Health Service (Osakidetza), Bilbao, Bizkaia, Spain. GONZALO.GRANDESODRIOZOLA@osakidetza.net.
authors: Gonzalo
authors: G
authors: Grandes
mesh_terms: D002985:Clinical Protocols; D015444:Exercise; D005081:Exercise Therapy; D006801:Humans; D009367:Neoplasm Staging; D009369:Neoplasms / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D011788:Quality of Life
references: BMJ. 2011;343:d6615
references: 22058135
references: Cochrane Database Syst Rev. 2012;11:CD006145
references: 23152233
references: BMJ. 2012;344:e70
references: 22294757
references: Nat Rev Clin Oncol. 2012 May;9(5):288-96
references: 22392097
references: Clin J Oncol Nurs. 2012 Jun 1;16(3):293-300
references: 22641322
references: Am J Prev Med. 2012 Aug;43(2):e1-24
references: 22813691
references: Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):e15-9
references: 23058059
references: Acta Oncol. 2013 Feb;52(2):195-215
references: 23244677
references: Eur J Oncol Nurs. 2013 Jun;17(3):331-9
references: 23084254
references: Oncologist. 2013;18(4):476-84
references: 23568000
references: Chest. 2013 May;143(5 Suppl):e420S-36S
references: 23649450
references: Med Sci Sports Exerc. 2013 Nov;45(11):2080-90
references: 23669878
references: Am J Phys Med Rehabil. 2014 Aug;93(8):675-86
references: 24743466
references: Semin Hematol. 2000 Oct;37(4 Suppl 6):14-7
references: 11068951
references: Psychooncology. 2002 May-Jun;11(3):249-56
references: 12112486
references: J Rehabil Med. 2003 Jul;35(4):153-62
references: 12892240
references: Lancet Oncol. 2003 Oct;4(10):616-25
references: 14554239
references: Med Clin (Barc). 1995 May 27;104(20):771-6
references: 7783470
references: J Clin Oncol. 2005 Feb 1;23(4):899-909
references: 15681536
references: Cancer Causes Control. 2004 Dec;15(10):1035-56
references: 15801488
references: J Palliat Med. 2006 Apr;9(2):409-21
references: 16629571
references: Support Care Cancer. 2006 Jul;14(7):699-712
references: 16447036
references: Cochrane Database Syst Rev. 2006;(4):CD005001
references: 17054230
references: Acta Oncol. 2007;46(8):1143-51
references: 17851864
references: Eur J Cancer. 2009 Jan;45(2):228-47
references: 19097774
references: Cancer Treat Rev. 2009 Jun;35(4):383-90
references: 19131171
references: Cancer. 2009 Oct 15;115(20):4874-84
references: 19637345
references: BMJ. 2009;339:b3410
references: 19826172
references: J Support Oncol. 2009 Sep-Oct;7(5):158-67
references: 19831159
references: Clin Oncol (R Coll Radiol). 2010 Apr;22(3):208-21
references: 20110159
references: Lancet Oncol. 2010 May;11(5):408-10
references: 20434709
references: Support Care Cancer. 2010 Jul;18(7):877-82
references: 19714371
references: Med Sci Sports Exerc. 2010 Jul;42(7):1409-26
references: 20559064
references: BMC Cancer. 2010;10:673
references: 21138561
references: Lancet. 2011 Jan 8;377(9760):127-38
references: 21183212
references: Int J Cancer. 2010 Dec 15;127(12):2893-917
references: 21351269
references: CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90
references: 21296855
references: Cochrane Database Syst Rev. 2011;(9):CD004282
references: 21901689
references: Antioxid Redox Signal. 2011 Nov 1;15(9):2543-63
references: 21457105
references: Cochrane Database Syst Rev. 2012;8:CD008465
references: 22895974
references: Lung Cancer. 2012 Feb;75(2):203-8
references: 21816503