Background:Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here.Methods:In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of ‘diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group.Results:At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (P=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0–37), absolute risk reduction 15% (95% CI: 0.3–29), number needed to treat (NNT)=7 (95% CI: 3–37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway.Conclusion:A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.

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.

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.

BackgroundLittle is known about the subjective experience of breast cancer survivors after primary treatment. However, these experiences are important because they shape their communication about their illness in everyday life, usage and acceptance of healthcare, and expectations of new generations of patients. The present study investigated this topic by combining qualitative and quantitative methods.MethodsBreast cancer survivors in Bavaria, Germany were mailed a questionnaire up to seven years after enrolment into a randomised controlled clinical trial and start of their therapy. This enquired about their worst experiences during the breast cancer episode, positive aspects of the illness and any advice they would give to newly diagnosed patients. A category system for themes was systematically created and answers were categorised by two independent raters. Frequencies of key categories were then quantitatively analysed using descriptive statistics. In addition, local treating physicians gave their opinion on the response categories chosen by their patients.Results133 (80 %) of 166 eligible patients who survived up to seven years returned the questionnaire. The most prominent worst experience reported by survivors was psychological distress (i.e. anxiety, uncertainty; prevalence 38 %) followed by chemotherapy (25 %), and cancer diagnosis (18 %). Positive aspects of the illness were reported by 48 % with the most frequent including change in life priorities (50 %) and social support (22 %). The most frequent advice survivors gave was fighting spirit (i.e. think positive, never give up; prevalence 42 %). Overall, physicians’ estimates of the frequency of these responses corresponded well with survivors’ answers.ConclusionsAlthough physicians’ understanding of breast cancer patients was good, psychological distress and chemotherapy-related side effects were remembered as particularly burdensome by a substantial part of survivors. On the one hand, patients’ quality of life needs to be assessed repeatedly during medical follow-up to identify such specific complaints also including specific recommendations to the physician for targeted psychosocial and medical support. On the other hand the advices and positive aspects of the disease, reported by the survivors, can be used to promote positive ways of coping with the illness.

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