e20517 Background: To improve breast cancer patients` quality of life (QoL) as second relevant outcome of care, a clinical pathway with diagnosis and therapy of diseased QoL has been developed, implemented and tested in a randomized trial (RCT) as part of a complex intervention. More than 6 years after RCT, long-term QoL of survivors was assessed and separately analyzed in 2 cohorts: QoL-intervention + guideline treatment in the first postoperative year (GC+) and guideline treatment alone (GC). Methods: Both cohorts were part of a randomized trial with 2 x 100 primary breast cancer patients, surgically treated between 2004 - 2006, with QoL measurement every 3 months during the first year (EORTC QLQ-C30, BR23). In GC+ cohort, QoL was presented to coordinating physicians in a QoL-profile, including recommendations for treatment of diseased QoL (cutoff <50 points on scale 0 = bad, 100 = good) in 10 dimensions (global QoL, physical, role, emotional, cognitive, social functioning, arm symptoms, body image, pain, fatigue) and up to 5 targeted therapies to improve QoL. GC was treated according to S3 guideline. At follow-up >6 years after diagnosis (range of months since surgery: GC+ 74-94; GC 74-96), rates of diseased QoL in both cohorts were analyzed and compared with QoL 12 months postoperatively. Results: Long-term QoL was assessed in 66 patients of GC+ (mean age 64.7 (±10.9)) and 67 of GC (mean age 63.7 (±10.9)) (death GC+=13, GC=18; response rate 79%). In GC+, 48% of patients reported at least 1 QoL deficit at 12 months compared with 52% at 6-year follow-up, while in GC rate of diseased QoL increased from 53% to 62%. Regarding single dimensions, in GC+ rates of diseased QoL increased from 12 months to 6 years (except global QoL), reaching significance for arm symptoms (9% vs 29%) and body image (3% vs 16%) (p<.01, McNemar`s test). In GC no dimension changed significantly, but rates of diseased QoL for arm symptoms (26% vs 31%) and body image (9% vs 17%) were already rather high at 12 months. Conclusions: Breast cancer patients need tailored QoL therapy, exceeding the first postoperative year. Similar to traditional medical care, QoL needs to be considered continuously by anchoring it in follow-up care.
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