Treatment of diseased quality of life in specific dimensions: Effectiveness of quality-of-life diagnosis and treatment in a community-based RCT in women with breast cancer.

Abstract

e16520 Background: Many studies described deficits in quality of life (QoL) in cancer patients. We developed a new pathway with QoL diagnosis and treatment which was implemented as complex intervention with theory building, modeling, exploratory trial and RCT, integrated in a population based (2.1 mio) Tumorcenter. Methods: We conducted a two-armed, randomized clinical trial with 200 breast cancer patients.QoL was measured prospectively in 10 specific dimensions in first year after surgery. Along new QoL pathway patients in intervention group (IG) received QoL diagnosis and treatment consisting of 5 therapeutic options (eg physiotherapy, psychotherapy, social counseling). Members of control group (CG) received standard postoperative care. Primary endpoint was rate of patients with diseased QoL (<50 points on at least one scale with 0=bad, 100=good QoL). χ2-tests were performed to compare rates of diseased QoL (Klinkhammer-Schalke et al, BrJCancer, 2012). Results: At begin of study there were no significant differences in both groups considering QoL. 6 months after surgery rate of patients with diseased QoL was significantly lower for emotion in IG (19.8%) vs CG (38.4%, p=.007), and for global QoL almost reached significance in IG (17.6%) vs CG (29.8%, p=.064). For other dimensions (except family life) there was a trend showing better QoL in IG, but results were not significant. Rates of patients with diseased QoL in 10 dimensions 6 months after surgery in intervention group [%] vs control [%]: Global QoL 17.6% vs 29.8%!, Physical functioning 4.7% vs 5.7%, Role functioning 26.4% vs 29.9%, Arm symptoms 13.8% vs 23.3%, Body image 13.8% vs 22.1%, Pain 19.5% vs 24.4%, Emotion 19.8 %vs 38.4%xx, Concentration, remembering 10.5% vs 17.4%, Fatigue 37.9 %vs 46.5%, Family life, social encounters 17.4% vs 16.3% (χ2-test: p<.10!, p<.01xx). Conclusions: Results confirm effectiveness of QoL pathway: 6 months after surgery IG showed better QoL in 2 important dimensions. Lower rates of diseased QoL in other dimensions support the result. Cancer patients will benefit from the QoL system implemented in clinical routine (long term implementation).