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.

Figure 1

QoL profiles and expert consensus reports of a specific intervention group patient with effective QoL diagnosis and therapy. Female, with primary breast cancer, randomly assigned to QoL diagnosis and treatment group; 50 years, married, one child. Prognostic classification pT1c, SN0, G2, ER⁺, PR⁺, HER2neu⁻. BCT with sentinel node excision followed by radiation and anti-oestrogen treatment in months 3 and 6 with Tamoxifen. Cutoff for diseased/healthy QoL 50 points (grey bar). Global QoL assessed by clinician (1 month) and CP (3 and 6 months): 100, 70, 85 points obtained by the physicians and the values of the patient in the figure, showed good doctor–patient agreement.

Figure 2

Care pathway for QoL diagnosis and therapy – QoL pathway – tailored to breast cancer patients.

Figure 3

Diagnosis and therapy of diseased QoL in breast cancer patients: design of a complex intervention.

Figure 4

Trial profile: flow of patients through each stage of the study. Complete=questionnaire answering the primary end point of the study. In Figure 6, only 83 instead of 85 patients could be analysed in the control group because no data were given for 1/10 QoL dimensions. Since, however, the two patients showed breakdowns in more than one dimension, the primary end point could be analysed and counted in them. Flowchart was constructed according to Altman (1996).

Figure 5

Proportion of patients with diseased QoL following breast cancer surgery and adjuvant therapies: comparison of QoL diagnosis and therapy (QoL pathway) with guideline consistent, traditional postoperative care (control) over 1 year. χ²-test: !=P<0.1, x=P<0.05.

Figure 6

Number of diseased QoL dimensions per patient 6 months after surgery: Comparison of QoL diagnosis and therapy pathway (dark bars, n=84) with that of standard postoperative care (light bars, n=83).

Figure 7

Proportions of patients with diseased global QoL and single dimensions of QoL: comparison of QoL pathway (▪) with traditional postoperative care (□). χ²-test: !=P<0.1, x=P<0.05, xx=P<0.01. (a) Period of QoL diagnosis; (b) period of QoL therapy; (c) period of follow-up (maintenance omitted if QoL ⩾50 points).

Figure 8

Mean values±s.d. for the 10 dimensions of the QoL profile: comparison of QoL pathway (▪) with traditional postoperative care (□). Mann–Whitney U-test !=P<0.10, x=P<0.05. Global QoL P=0.018, Emotion P=0.030 and P=0.060, respectively, Fatigue P=0.051. (a) Period of QoL diagnosis; (b) period of QoL therapy; (c) period of follow-up (maintenance omitted if QoL ⩾50 points).