EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning

An De Groef, Nele Devoogdt, Elien Van der Gucht, Lore Dams, Koen Bernar, Lode Godderis, Bart Morlion, Niamh Moloney, Ann Smeets, Paul Van Wilgen, Mira Meeus

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
2 Downloads (Pure)

Abstract

Introduction: Over the past decades, awareness on the importance of educational interventions in cancer pain management has increased. However, education is often restricted to biomedical pain management instructions. A more modern educational approach, also known as pain neuroscience education (PNE), explains pain from a biopsychosocial perspective. We hypothesise that this more comprehensive educational approach in the early treatment phase of breast cancer will lead to more beneficial effects for cancer pain management. Therefore, the aim of the present study is to investigate the effectiveness of this PNE intervention, in addition to best evidence physical therapy modalities for treatment and prevention of pain, physical, emotional and work-related functioning after breast cancer surgery, compared with a traditional biomedical educational intervention.

Methods: A double-blinded randomised controlled trial has been started in November 2017 at the University Hospitals of Leuven. Immediately after breast cancer surgery, all participants (n=184) receive a 12-week intensive standard physical therapy programme. They receive three additional refresher sessions at 6, 8 and 12 months postsurgery. In addition, participants receive three educational sessions during the first-month postsurgery and three 'booster sessions' at 6, 8 and 12 months postsurgery. In the intervention group, the content of the education sessions is based on the modern PNE approach. Whereas in the control group, the education is based on the traditional biomedical approach. The primary outcome parameter is pain-related disability 1 year after surgery. Secondary outcomes related to other dimensions of pain, physical, emotional and work-related functioning at 1-week, 4, 6, 8, 12 and 18 months postsurgery.

Ethics and dissemination: The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals of Leuven. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.

Trial registration number: NCT03351075.

Original languageEnglish
Article numbere025742
Pages (from-to)1-10
Number of pages10
JournalBMJ Open
Volume9
Issue number1
DOIs
Publication statusPublished - 4 Jan 2019

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Breast Neoplasms/complications
  • Double-Blind Method
  • Emotions
  • Female
  • Humans
  • Mastectomy
  • Pain/prevention & control
  • Patient Education as Topic/methods
  • Physical Therapy Modalities/education
  • Randomized Controlled Trials as Topic
  • Work Capacity Evaluation

Fingerprint

Dive into the research topics of 'EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning'. Together they form a unique fingerprint.

Cite this