Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial

BMC Cancer

Study Protocol

Elles Steenhagen¹  Peter D. Siersema²  Grard A. P. Nieuwenhuijzen³  Richard P. R. Groenendijk⁴  Camiel Rosman⁵  Eric J. Hazebroek⁶  Carlo C. G. Schippers⁷  Richard van Hillegersberg⁷  Donald L. van der Peet⁸  Ewout A. Kouwenhoven⁹  Anne M. May^1,10  Jonna K. van Vulpen^1,10  Petra H. M. Peeters^1,11 

[1] Department of Dietetics, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands;Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands;Department of Gastroenterology and Hepatology, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands;Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands;Department of Surgery, IJsselland Hospital, Prins Constantijnweg 2, 2906 ZC, Capelle a/d IJssel, The Netherlands;Department of Surgery, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands;Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, 3430 VB, Nieuwegein, The Netherlands;Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands;Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands;Department of Surgery, ZGT Hospital, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands;School of Public Health, Imperial College London, South Kensington Campus, SW7 2AZ, London, UK;

关键词: Esophageal cancer;    Physical exercise;    Quality of life;    Randomized controlled trial;   

DOI  :  10.1186/s12885-017-3542-8

 received in 2016-12-15, accepted in 2017-08-11,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundFollowing esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.MethodsThe Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient’s home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.DiscussionThis randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registrationTrial registration:Netherlands Trial Registry NTR5045Date of trial registration: January 19th, 2015Date and version study protocol: February 2017, version 1

【 授权许可】

CC BY   
© The Author(s). 2017