title: Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial.
abstract: Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors.
  
  
  
  To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60 years with a Karnofsky Performance Status of ≥70 %, a preliminary positive social-medical prognosis of employability for at least 3 h/day within the next 6 months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients' capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC-QLQ30. Secondary outcome measures are the remaining scales of the EORTC-QLQ30, fatigue, self-rated work ability, disease coping, participation in working life, realization of work-related goals and therapies during rehabilitation, and treatment satisfaction.
  
  
  
  A positive evaluation of work-related medical rehabilitation in cancer patients is expected due to the promising findings on the effectiveness of such programs for patients with other health conditions. Results may support the dissemination of work-related medical rehabilitation programs in German cancer rehabilitation.
  
  
  
  German Clinical Trials Register DRKS00007770 . Registered 13 May 2015.
authors.affiliation: Institute for Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. julian.wienert@uksh.de.
authors.forename: Julian
authors.identifier: 0000-0003-1246-7591
authors.initials: J
authors.lastname: Wienert
authors.affiliation: Institute for Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
authors.forename: Betje
authors.initials: B
authors.lastname: Schwarz
authors.affiliation: Institute for Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Bethge
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000534:rehabilitation*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015397:Program Evaluation; D011788:Quality of Life; D012107:Research Design; D062707:Return to Work / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Cancer; Cluster-randomized trial; Inclusion; Medical rehabilitation; Return to work; Study protocol; Work-related medical rehabilitation; Work-related therapies