Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT

Abstract

A system for quality-of-life diagnosis and therapy (QoL system) was implemented for breast cancer patients. The system fulfilled the criteria for complex interventions (Medical Research Council). Following theory and modeling, this study contains the exploratory trial as a next step before the randomised clinical trial (RCT) answering three questions: (1) Are there differences between implementation sample and general population? (2) Which amount and type of disagreement exist between patient and coordinating practitioners (CPs) in assessed global QoL? (3) Are there empirical reasons for a cutoff of 50 points discriminating between healthy and diseased QoL? Implementation was successful: 74% of CPs worked along the care pathway. However, CPs showed preferences for selecting patients with lower age and UICC prognostic staging. Patients and CPs disagreed considerably in values of global QoL, despite education in QoL assessment by outreach visits, opinion leaders and CME: Zero values of QoL were only expressed by patients. Finally, the cutoff of 50 points was supported by the relationship between QoL in single items and global QoL: no patients with values above 50 dropped global QoL below 50, but values below 50 and especially at 0 points in single items, induced a dramatic fall of global QoL down to below 50. The exploratory trial was important for defining the complex intervention in the definitive RCT: control for age and prognostic stage grading, support for a QoL unit combining patient's and CP's assessment of QoL and support for the 50-point cutoff criterion between healthy and diseased QoL.

The Impact of Breast Care Nurses on Patients’ Satisfaction, Understanding of the Disease, and Adherence to Adjuvant Endocrine Therapy

“…Women who had been supported by a BCN had a significantly better post-discharge quality of life up to 1 year after leaving hospital than patients without any such contact. Particularly the scores of patients who did not have any contact with a BCN are comparable with the figures given in the literature (Klinkhammer-Schalke et al [9] mean score 61.5; Kerr et al [10] mean score 63.7). The mean scores of patients who had contact with a BCN, on the other hand, are more consistent with the mean scores in the general female population (range 63.7-69.7) determined by Schwarz et al [11].…”

Challenges to evaluating complex interventions: a content analysis of published papers

“…Apart from difficulties in deciding upon measureable outcomes imposed by the complexity of interventions, writers noted that there is now an expectation that the bio-psycho-social aspects of interventions be measured as well as the clinical ones [45]. In palliative care, for example, patient experience is the primary outcome [46].…”

Sexual quality of life in Hodgkin Lymphoma: a longitudinal analysis by the German Hodgkin Study Group

“…As there are no established threshold levels for the evaluation of specific QoL dimensions, we choose a 50-point cutoff for the discrimination between patients with or without SX impairment as this value is proposed as threshold level for clinical interventions (Klinkhammer-Schalke et al , 2008). By choosing this cutoff point, we only rely on serious impairments of SX whose relevance can hardly be denied.…”