Original Article

Langenbeck's Archives of Surgery

, Volume 393, Issue 1, pp 1-12

First online:

Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling)

  • Monika Klinkhammer-SchalkeAffiliated withTumor Center Regensburg Email author 
  • , Michael KollerAffiliated withCenter for Clinical Trials, University Hospital Regensburg
  • , Jeremy C. WyattAffiliated withHealth Informatics Centre, University of Dundee
  • , Brunhilde SteingerAffiliated withTumor Center Regensburg
  • , Christoph EhretAffiliated withTumor Center Regensburg
  • , Brigitte ErnstAffiliated withTumor Center Regensburg
  • , Ferdinand HofstädterAffiliated withTumor Center Regensburg
  • , Wilfried LorenzAffiliated withTumor Center Regensburg

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Background and aims

A system for quality of life (QoL) diagnosis and therapy in breast cancer patients was developed according to the Medical Research Council (MRC) framework of complex interventions. Along MRC’s five phases in the continuum of evidence, the present paper deals with phase I: modeling (i.e., delineating the conceptual, methodological, and logistic requirements).

Basic elements

Theoretical background is a new conceptualization of QoL that provides a rational basis to diagnose “diseased” QoL. A care pathway as the central part of modeling is composed of the following interrelated structural elements: patients (n = 170), clinicians (n = 10), experts in a quality of life unit (n = 5), coordinating practitioners (n = 38), local opinion leaders (n = 12), and professional therapists for QoL enhancing therapies (n = 75). Networking of these structural elements was achieved by clinical algorithm. In the clinical center, the patient and doctor delivered a questionnaire (EORTC) and health status report. The QoL unit transformed it into a profile and experts’ report. The coordinating practitioner transformed the latter into a decision on QoL therapy and the care pathway ended with the professional therapists. Implementation of this system used a multifaceted strategy including educational outreach visits, local opinion leaders, and quality circles.


The suffering cancer patient is the main focus of this QoL diagnosis and therapy system. It will have to pass the rigorous test of a definitive randomized trial.


Complex intervention Modeling Quality of life Breast cancer Implementation