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Randomized Controlled Trial
. 2025 Apr 30;112(5):znaf031.
doi: 10.1093/bjs/znaf031.

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

Veerle M Wintraecken  1   2 , Lori M van Roozendaal  3 , Janine M Simons  1   4 , Jolanda de Vries  5   6 , Sander M J van Kuijk  7 , Marissa L G Vane  1   2 , Thijs van Dalen  8   9 , Helena Sackey  10   11 , Jos A van der Hage  12 , Luc J A Strobbe  13 , Sabine C Linn  14 , Marc B I Lobbes  15 , Philip M P Poortmans  16   17 , Vivianne C G Tjan-Heijnen  1   18 , Koen K B T van de Vijver  19   20   21 , Helen H Westenberg  22 , Carmen D Dirksen  7   23 , Johan H W de Wilt  24 , Liesbeth J Boersma  25 , Marjolein L Smidt  1   2
Affiliations
Randomized Controlled Trial

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

Veerle M Wintraecken et al. Br J Surg. .

Abstract

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).

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Figures

Fig. 1
Fig. 1
Flow chart HRQoL, health-related quality of life; DCIS, ductal carcinoma in situ; SLNB, sentinel lymph node biopsy.
Fig. 2
Fig. 2
Arm function and health-related quality-of-life scores by treatment group a Lymph-ICF physical function score. b Lymph-ICF mental function score. c HRQoL arm symptom score. d HRQoL breast symptom score. SLNB, sentinel lymph node biopsy; Lymph-ICF, Lymphoedema Functioning, Disability, and Health questionnaire; HRQoL, health-related quality of life.
Fig. 3
Fig. 3
Arm function scores by personality group and by treatment group a Lymph-ICF physical function score. b Lymph-ICF mental function score. c Lymph-ICF household domain score. d Lymph-ICF mobility domain score. e Lymph-ICF social domain score. SLNB, sentinel lymph node biopsy; TA, trait anxiety; N, neuroticism; Lymph-ICF, Lymphoedema Functioning, Disability, and Health questionnaire.
Fig. 4
Fig. 4
Health-related quality-of-life scores by personality group and by treatment group a HRQoL arm symptom score. b HRQoL breast symptom score. c HRQoL emotional functioning score. d HRQoL cognitive functioning score. e HRQoL future perspective score. f HRQoL fatigue symptom score. g HRQoL pain symptom score. h HRQoL insomnia symptom score. i HRQoL constipation symptom score. SLNB, sentinel lymph node biopsy; TA, trait anxiety; N, neuroticism; HRQoL, health-related quality of life.
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References

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