Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life.

BACKGROUND The non-inferiority randomized controlled trial BOOG 2013-08 investigates the oncological safety and impact on health-related quality of life (HRQoL) of sentinel lymph node biopsy (SNLB) omission in cT1-2 N0 breast cancer. The primary aim of the present study was to compare patient-reported arm function and HRQoL up to 3 years after study inclusion in cT1-2 N0 patients with breast cancer undergoing breast-conserving surgery (BCS) with or without SLNB. The secondary aim was to explore the association between personality traits 'trait anxiety' and 'neuroticism', and perceived arm function and HRQoL. METHODS A total of 1733 women with unilateral cT1-2 N0 invasive breast cancer treated with BCS with or without SLNB were included. The primary outcomes of arm function (assessed using the Lymphoedema Functioning, Disability, and Health Questionnaire) and HRQoL (assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR-23 questionnaires) were analysed. RESULTS Analyses included 821 patients (383 with SLNB and 438 without SLNB). Those in the SLNB group experienced a slight, temporary decline in arm function (P < 0.025) and reported more HRQoL arm and breast symptoms (P < 0.049). High trait anxiety or neuroticism was associated with significant poorer arm function and lower HRQoL. CONCLUSION SLNB slightly reduced arm function, temporarily affecting HRQoL arm and breast symptoms. Neuroticism significantly negatively impacted arm function and HRQoL. Measuring and stratifying for personality traits is crucial for interpreting patient-reported outcomes and to identify patients needing additional support after surgery. REGISTRATION NUMBER NCT02271828 (http://www.clinicaltrials.gov).