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

doi:10.1136/bmjopen-2018-025742

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

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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 language	English
Article number	e025742
Pages (from-to)	1-10
Number of pages	10
Journal	BMJ Open
Volume	9
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2018-025742
Publication status	Published - 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

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10.1136/bmjopen-2018-025742

Publisher version (open access)Final published version, 468 KBLicence: CC BY-NC

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De Groef, A., Devoogdt, N., Van der Gucht, E., Dams, L., Bernar, K., Godderis, L., Morlion, B., Moloney, N., Smeets, A., Van Wilgen, P., & Meeus, M. (2019). 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. BMJ Open, 9(1), 1-10. [e025742]. https://doi.org/10.1136/bmjopen-2018-025742

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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.",

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

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doi = "10.1136/bmjopen-2018-025742",

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De Groef, A, Devoogdt, N, Van der Gucht, E, Dams, L, Bernar, K, Godderis, L, Morlion, B, Moloney, N, Smeets, A, Van Wilgen, P & Meeus, M 2019, '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', BMJ Open, vol. 9, no. 1, e025742, pp. 1-10. https://doi.org/10.1136/bmjopen-2018-025742

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. / De Groef, An; Devoogdt, Nele; Van der Gucht, Elien et al.

In: BMJ Open, Vol. 9, No. 1, e025742, 04.01.2019, p. 1-10.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - EduCan trial

T2 - 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

AU - De Groef, An

AU - Devoogdt, Nele

AU - Van der Gucht, Elien

AU - Dams, Lore

AU - Bernar, Koen

AU - Godderis, Lode

AU - Morlion, Bart

AU - Moloney, Niamh

AU - Smeets, Ann

AU - Van Wilgen, Paul

AU - Meeus, Mira

N1 - 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.

PY - 2019/1/4

Y1 - 2019/1/4

N2 - 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.

AB - 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.

KW - Breast Neoplasms/complications

KW - Double-Blind Method

KW - Emotions

KW - Female

KW - Humans

KW - Mastectomy

KW - Pain/prevention & control

KW - Patient Education as Topic/methods

KW - Physical Therapy Modalities/education

KW - Randomized Controlled Trials as Topic

KW - Work Capacity Evaluation

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DO - 10.1136/bmjopen-2018-025742

M3 - Article

C2 - 30612114

VL - 9

SP - 1

EP - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

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M1 - e025742

ER -

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

Abstract

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