Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer

Abstract

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.

Quality of life in breast cancer survivors

“…The current understanding of FC is quite holistic in that it includes not only areas of physical performance, such as muscular strength, cardiopulmonary endurance and range of motion, but also the emotional and psychological state as well as environmental and social circumstances. [11][12][13][14][15][16] According to the World Health Organization's International Classification of Functioning, Disability and Health (ICF), function is defined as the interactions between an individual, their health condition and the social and personal context in which they live. [16][17][18] It is the complex interaction between these factors that determines function and impairment.…”

Patientenwohl. Lebensqualität bei Brustkrebs-Patientinnen – Implementierung und Umsetzung in die Routineversorgung

“…Nach Theoriebildung (präklinisch) [2,4,5], Identifikation relevanter Faktoren für das Outcome im Rahmen der Modellbildung (Phase I) [6] und explorativer Studie (Phase II mit n = 170 Patientinnen) [7], folgten die randomisierte Studie (Phase III mit n = 200 Patientinnen) [9] und die Langzeitimplementierung (Phase IV mit Follow-up-Erhebung n = 133). Die einzelnen patientenbezogenen Phasen wurden in die bestehende Netzwerkstruktur eines bevölkerungsbezogenen klinischen Krebsregisters ( …”

Psychological Assessment in Psychopharmacology

“…There is however momentum building for multi-domain Screening for Distress, as the 6th vital sign globally. Twelve randomised trials that have examined screening for psychological problems (or wellbeing) divided in six concerning emotional complications and six involving QL and one that studied both domains (Table 4.1) (Maunsell et al 1996;Sarna 1998;McLachlan et al 2001;Detmar et al 2002;Velikova et al 2004;Mills et al 2009;Carlson et al 2010bCarlson et al , 2012Braeken et al 2011;Klinkhammer-Schalke et al 2012;Hollingworth et al 2012). For example, in one British study, 28 oncologists treating 286 cancer patients were randomly assigned to an intervention group who underwent screening along with feedback of results to physicians, a screen-only group who completed questionnaires without feedback and a control group with no screening at all (Velikova et al 2004(Velikova et al , 2010.…”