EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial
Anne M May,
Maike G Sweegers,
Wim H Van Harten,
Martijn M Stuiver,
Alina Vrieling,
Richard P Meijer,
Antoine G van der Heijden,
Wim G Groen,
Emine Akdemir,
Helene Rundqvist,
Annemarie M Leliveld-Kors,
Vera C Rutten,
Evert L Koldewijn,
Siebe D Bos,
Carl J Wijburg,
Tom A T Marcelissen,
Bart C Bongers,
Valesca P Retèl
Affiliations
Anne M May
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
Maike G Sweegers
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Wim H Van Harten
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Martijn M Stuiver
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Alina Vrieling
Department for Health Evidence, Radboud Univerity Medical Center, Nijmegen, The Netherlands
Richard P Meijer
Department of Oncological Urology, University Medical Center Utrecht, Utrecht, The Netherlands
Antoine G van der Heijden
Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands
Wim G Groen
Amsterdam Public Health, Aging & Later Life, Amsterdam, The Netherlands
Emine Akdemir
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Helene Rundqvist
Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden
Annemarie M Leliveld-Kors
Department of Urology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Vera C Rutten
Department of Urology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands
Evert L Koldewijn
Department of Urology, Catharina Hospital, Eindhoven, The Netherlands
Siebe D Bos
Department of Urology, Noordwest Hospital Group, Alkmaar, The Netherlands
Carl J Wijburg
Department of Urology, Rijnstate Hospital, Arnhem, The Netherlands
Tom A T Marcelissen
Department of Urology, Maastricht University Medical Center+, Maastricht, The Netherlands
Bart C Bongers
Department of Nutrition and Movement Sciences, Nutrition and Translational Research in Metabolism (NUTRIM), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
Valesca P Retèl
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Introduction Radical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50–65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient’s preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC.Methods and analysis This multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3–6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery.Ethics and dissemination Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22–595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals.Trial registration number NCT05480735.
