Effect of perceived injustice-targeted pain neuroscience education compared with biomedically focused education in breast cancer survivors: a study protocol for a multicentre randomised controlled trial (BCS-PI trial)
IntroductionCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to inc...
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Published in: | BMJ open Vol. 14; no. 1; p. e075779 |
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01-01-2024
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Abstract | IntroductionCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.Methods and analysisThis two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.Ethics and disseminationThe ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.Trial registration numberNCT04730154. |
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AbstractList | Introduction Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.Methods and analysis This two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.Ethics and dissemination The ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.Trial registration number NCT04730154. IntroductionCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.Methods and analysisThis two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.Ethics and disseminationThe ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.Trial registration numberNCT04730154. Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain. This two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective. The ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals. NCT04730154. INTRODUCTION: Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain. METHODS AND ANALYSIS: This two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective. ETHICS AND DISSEMINATION: The ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals. Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.INTRODUCTIONCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.This two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.METHODS AND ANALYSISThis two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.The ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.ETHICS AND DISSEMINATIONThe ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.NCT04730154.TRIAL REGISTRATION NUMBERNCT04730154. |
Author | Huysmans, Eva Timmermans, Annick Mostaqim, Kenza Leysen, Laurence Nijs, Jo Van Wilgen, Paul Beckwée, David De Couck, Marijke Lahousse, Astrid Roose, Eva Bults, Rinske |
AuthorAffiliation | 5 Department of Physiotherapy , Vrije Universiteit Brussel , Brussel , Belgium 4 Rehabilitation Research Group , Vrije Universiteit Brussel , Brussel , Belgium 3 Department of Physical Medicine and Physiotherapy , Universitair Ziekenhuis Brussel , Brussels , Belgium 7 Transcare Pain Transdisciplinary Pain Treatment Center , Groningen , Netherlands 1 Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy , Vrije Universiteit Brussel , Brussels , Belgium 8 Department of Rehabilitation Sciences and Physiotherapy , University of Antwerp , Antwerpen , Belgium 6 Research Foundation-Flanders , (FWO) , Brussels , Belgium 9 Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy , University of Gothenburg , Gotenburg , Sweden 2 REVAL Research Group , Universiteit Hasselt , Diepenbeek , Belgium |
AuthorAffiliation_xml | – name: 8 Department of Rehabilitation Sciences and Physiotherapy , University of Antwerp , Antwerpen , Belgium – name: 2 REVAL Research Group , Universiteit Hasselt , Diepenbeek , Belgium – name: 5 Department of Physiotherapy , Vrije Universiteit Brussel , Brussel , Belgium – name: 3 Department of Physical Medicine and Physiotherapy , Universitair Ziekenhuis Brussel , Brussels , Belgium – name: 4 Rehabilitation Research Group , Vrije Universiteit Brussel , Brussel , Belgium – name: 7 Transcare Pain Transdisciplinary Pain Treatment Center , Groningen , Netherlands – name: 1 Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy , Vrije Universiteit Brussel , Brussels , Belgium – name: 9 Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy , University of Gothenburg , Gotenburg , Sweden – name: 6 Research Foundation-Flanders , (FWO) , Brussels , Belgium |
Author_xml | – sequence: 1 givenname: Eva orcidid: 0000-0001-8720-6543 surname: Roose fullname: Roose, Eva organization: Rehabilitation Research Group, Vrije Universiteit Brussel, Brussel, Belgium – sequence: 2 givenname: Eva surname: Huysmans fullname: Huysmans, Eva organization: Research Foundation-Flanders, (FWO), Brussels, Belgium – sequence: 3 givenname: Laurence surname: Leysen fullname: Leysen, Laurence organization: Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium – sequence: 4 givenname: Kenza surname: Mostaqim fullname: Mostaqim, Kenza organization: Research Foundation-Flanders, (FWO), Brussels, Belgium – sequence: 5 givenname: Paul surname: Van Wilgen fullname: Van Wilgen, Paul organization: Transcare Pain Transdisciplinary Pain Treatment Center, Groningen, Netherlands – sequence: 6 givenname: David orcidid: 0000-0001-9951-9993 surname: Beckwée fullname: Beckwée, David organization: Department of Rehabilitation Sciences and Physiotherapy, University of Antwerp, Antwerpen, Belgium – sequence: 7 givenname: Marijke surname: De Couck fullname: De Couck, Marijke organization: Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium – sequence: 8 givenname: Annick surname: Timmermans fullname: Timmermans, Annick organization: REVAL Research Group, Universiteit Hasselt, Diepenbeek, Belgium – sequence: 9 givenname: Rinske surname: Bults fullname: Bults, Rinske organization: Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium – sequence: 10 givenname: Jo surname: Nijs fullname: Nijs, Jo email: jo.nijs@vub.be organization: Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gotenburg, Sweden – sequence: 11 givenname: Astrid orcidid: 0000-0003-3967-8348 surname: Lahousse fullname: Lahousse, Astrid organization: Department of Physical Medicine and Physiotherapy, Universitair Ziekenhuis Brussel, Brussels, Belgium |
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DOI | 10.1136/bmjopen-2023-075779 |
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Keywords | Breast tumours Cancer pain Pain management |
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18 2024022401011740000_14.1.e075779.43 2024022401011740000_14.1.e075779.44 2024022401011740000_14.1.e075779.46 Moser (2024022401011740000_14.1.e075779.33) 2014; 12 2024022401011740000_14.1.e075779.49 Van Wilder (2024022401011740000_14.1.e075779.78) 2022; 31 Trost (2024022401011740000_14.1.e075779.68) 2015; 60 Gulluoglu (2024022401011740000_14.1.e075779.47) 2006; 51 Fox (2024022401011740000_14.1.e075779.106) 2018; 121 Otte (2024022401011740000_14.1.e075779.97) 2013; 45 2024022401011740000_14.1.e075779.51 2024022401011740000_14.1.e075779.52 2024022401011740000_14.1.e075779.53 2024022401011740000_14.1.e075779.55 Lee (2024022401011740000_14.1.e075779.50) 2013; 21 2024022401011740000_14.1.e075779.56 2024022401011740000_14.1.e075779.59 Huang (2024022401011740000_14.1.e075779.54) 2019; 28 Perez (2024022401011740000_14.1.e075779.92) 2007; 5 De Groef (2024022401011740000_14.1.e075779.45) 2019; 8 De Groef (2024022401011740000_14.1.e075779.26) 2023; 31 Hinz (2024022401011740000_14.1.e075779.48) 2012; 21 2024022401011740000_14.1.e075779.20 2024022401011740000_14.1.e075779.23 2024022401011740000_14.1.e075779.24 2024022401011740000_14.1.e075779.29 2024022401011740000_14.1.e075779.108 2024022401011740000_14.1.e075779.109 Cleeland (2024022401011740000_14.1.e075779.62) 1994; 23 2024022401011740000_14.1.e075779.102 2024022401011740000_14.1.e075779.103 2024022401011740000_14.1.e075779.104 2024022401011740000_14.1.e075779.100 Secinti (2024022401011740000_14.1.e075779.69) 2023; 65 Gutiérrez-Sánchez (2024022401011740000_14.1.e075779.25) 2022; 23 Harrington (2024022401011740000_14.1.e075779.7) 2014; 32 Van Damme S, C.G (2024022401011740000_14.1.e075779.101) 2000; 3 2024022401011740000_14.1.e075779.30 Van Seventer (2024022401011740000_14.1.e075779.93) 2010; 14 2024022401011740000_14.1.e075779.32 Bults (2024022401011740000_14.1.e075779.67) 2020; 13 2024022401011740000_14.1.e075779.35 Louw (2024022401011740000_14.1.e075779.22) 2021; 51 2024022401011740000_14.1.e075779.36 2024022401011740000_14.1.e075779.37 Fayers (2024022401011740000_14.1.e075779.65) 2002; 38 2024022401011740000_14.1.e075779.110 2024022401011740000_14.1.e075779.111 2024022401011740000_14.1.e075779.112 Jacobs (2024022401011740000_14.1.e075779.113) 2008; 41 Bennett (2024022401011740000_14.1.e075779.89) 2005; 54 2024022401011740000_14.1.e075779.80 2024022401011740000_14.1.e075779.81 2024022401011740000_14.1.e075779.83 2024022401011740000_14.1.e075779.84 2024022401011740000_14.1.e075779.85 2024022401011740000_14.1.e075779.86 2024022401011740000_14.1.e075779.87 2024022401011740000_14.1.e075779.88 Carey (2024022401011740000_14.1.e075779.105) 2019; 14 Nijs (2024022401011740000_14.1.e075779.28) 2020; 100 Carriere (2024022401011740000_14.1.e075779.21) 2017; 21 Nijs (2024022401011740000_14.1.e075779.31) 2021; 24 van Seventer (2024022401011740000_14.1.e075779.57) 2013; 13 2024022401011740000_14.1.e075779.90 2024022401011740000_14.1.e075779.91 Lahousse (2024022401011740000_14.1.e075779.19) 2022; 23 2024022401011740000_14.1.e075779.96 2024022401011740000_14.1.e075779.10 2024022401011740000_14.1.e075779.98 2024022401011740000_14.1.e075779.11 2024022401011740000_14.1.e075779.99 2024022401011740000_14.1.e075779.12 2024022401011740000_14.1.e075779.13 Kregel (2024022401011740000_14.1.e075779.58) 2016; 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Snippet | IntroductionCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of... Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with... INTRODUCTION: Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22%... Introduction Current treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22%... |
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SubjectTerms | Analgesics, Opioid Breast cancer Breast Neoplasms - complications Breast tumours Cancer pain Cancer Survivors Cancer therapies Chronic illnesses Chronic pain Clinical Medicine Cognitive ability Collaboration Communication Education Fatigue Female Hospitals Humans Injustice Intervention Klinisk medicin Multicenter Studies as Topic Narcotics Neurosciences Oncology Pain Pain management Patients Perceptions Quality of Life Questionnaires Randomized Controlled Trials as Topic Survivor |
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Title | Effect of perceived injustice-targeted pain neuroscience education compared with biomedically focused education in breast cancer survivors: a study protocol for a multicentre randomised controlled trial (BCS-PI trial) |
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