Evidence map›Paper›PMID 40365927›Full record

Trial reportThe British journal of surgery2025

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, Lori M van Roozendaal, Janine M Simons, Jolanda de Vries, Sander M J van Kuijk, Marissa L G Vane, Thijs van Dalen, Helena Sackey, Jos A van der Hage, Luc J A Strobbe and 10 more

Registry-linked trialAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02271828 (Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02271828 naactive not recruitingnot on this map

Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

TypeinterventionalSponsorMaastricht University Medical CenterRan2015 to 2027Enrolled1,644ConditionsBreast NeoplasmsArmsSentinel lymph node procedure
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Veerle M WintraeckenGROW-Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.ORCID 0000-0002-2642-8385
Lori M van RoozendaalDepartment of Surgical Oncology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Janine M SimonsGROW-Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.
Jolanda de VriesDepartment of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands.
Sander M J van KuijkDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Marissa L G VaneGROW-Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.
Thijs van DalenDivision of Surgical Oncology, Diakonessenhuis Hospital, Utrecht, The Netherlands.ORCID 0000-0003-0882-9086
Helena SackeyDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Jos A van der HageDivision of Surgical Oncology, Leids University Medical Centre, Leiden, The Netherlands.
Luc J A StrobbeDivision of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.ORCID 0000-0002-3840-3003
Sabine C LinnDivision of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
Marc B I LobbesDepartment of Medical Imaging, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Philip M P PoortmansDepartment of Radiation Oncology, Iridium Network, Antwerp, Belgium.
Vivianne C G Tjan-HeijnenGROW-Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.
Koen K B T van de VijverDepartment of Pathology, Ghent University Hospital, Ghent, Belgium.
Helen H WestenbergRadiation Oncology, Radiotherapiegroep location Arnhem, Arnhem, The Netherlands.
Carmen D DirksenDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Johan H W de WiltDivision of Surgical Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Liesbeth J BoersmaDepartment of Radiation Oncology (Maastro), GROW-Research Institute for Oncology and Reproduction, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Marjolein L SmidtGROW-Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.

Funding

Dutch Cancer Society UM 2014-6679ZonMw 843002624
6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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.

resultsAnalyses 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.

conclusionSLNB 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).

Indexed as

Breast NeoplasmsMastectomy, SegmentalPatient Reported Outcome MeasuresPersonalityQuality of LifeSentinel Lymph Node BiopsyAdultAgedAnxietyFemaleHumansMiddle AgedNeoplasm Staging

Identifiers

PMID40365927
PMCPMC12076147

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.