title: Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial.
abstract: Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy.
  
  
  
  Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.
  
  
  
  This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.
  
  
  
  NTR5255 Protocol version 4 date September 2015.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Femke
authors.initials: F
authors.lastname: Jansen
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Ingrid C
authors.initials: IC
authors.lastname: Cnossen
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Simone E J
authors.initials: SE
authors.lastname: Eerenstein
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Veerle M H
authors.initials: VM
authors.lastname: Coupé
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Birgit I
authors.initials: BI
authors.lastname: Witte
authors.affiliation: Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081, BT, Amsterdam, The Netherlands.
authors.forename: Cornelia F
authors.initials: CF
authors.lastname: van Uden-Kraan
authors.affiliation: Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: Patricia
authors.initials: P
authors.lastname: Doornaert
authors.affiliation: Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
authors.forename: Weibel W
authors.initials: WW
authors.lastname: Braunius
authors.affiliation: Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
authors.forename: Remco
authors.initials: R
authors.lastname: De Bree
authors.affiliation: Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.
authors.forename: José A U
authors.initials: JA
authors.lastname: Hardillo
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.
authors.forename: Jimmie
authors.initials: J
authors.lastname: Honings
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700, RB, Groningen, The Netherlands.
authors.forename: György B
authors.initials: GB
authors.lastname: Halmos
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
authors.forename: C René
authors.initials: CR
authors.lastname: Leemans
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands. im.verdonck@vumc.nl.|Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081, BT, Amsterdam, The Netherlands. im.verdonck@vumc.nl.
authors.forename: Irma M
authors.initials: IM
authors.lastname: Verdonck-de Leeuw
mesh_terms: D003362:Cost-Benefit Analysis; D003680:Deglutition Disorders / Q000209:etiology / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000191:economics*; D005260:Female; D006801:Humans; D007825:Laryngectomy / Q000009:adverse effects*; D008297:Male; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000191:economics / Q000379:methods*; D013064:Speech Disorders / Q000235:genetics / Q000534:rehabilitation*; D016896:Treatment Outcome
keywords: Exercise program; Head and neck cancer; Shoulder problems; Speech problems; Swallowing problems; Total laryngectomy