{
  "abstract": "Introduction Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).Methods and analysis A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.Trial registration number ClinicalTrials.gov Identifier: NCT06308029.",
  "authors": [
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, KU Leuven – University of Leuven, Leuven, Belgium",
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium"
      ],
      "name": "An De Groef"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium",
        "Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium"
      ],
      "name": "Lore Dams"
    },
    {
      "affiliations": [
        "Innovation, Implementation & Clinical Translation (IIMPACT) in Health, University of South Australia, Kaurna Country, Adelaide, South Australia, Australia"
      ],
      "name": "G Lorimer Moseley"
    },
    {
      "affiliations": [
        "Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology, and Neuroscience, King’s College London, Londen, UK"
      ],
      "name": "Lauren C Heathcote"
    },
    {
      "affiliations": [
        "Innovation, Implementation & Clinical Translation (IIMPACT) in Health, University of South Australia, Kaurna Country, Adelaide, South Australia, Australia",
        "Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia"
      ],
      "name": "Louise K Wiles"
    },
    {
      "affiliations": [
        "Innovation, Implementation & Clinical Translation (IIMPACT) in Health, University of South Australia, Kaurna Country, Adelaide, South Australia, Australia"
      ],
      "name": "Mark Catley"
    },
    {
      "affiliations": [
        "Innovation, Implementation & Clinical Translation (IIMPACT) in Health, University of South Australia, Kaurna Country, Adelaide, South Australia, Australia"
      ],
      "name": "Anna Vogelzang"
    },
    {
      "affiliations": [
        "Innovation, Implementation & Clinical Translation (IIMPACT) in Health, University of South Australia, Kaurna Country, Adelaide, South Australia, Australia",
        "Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia"
      ],
      "name": "Peter Hibbert"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Sciences, Section Anaesthesiology & Algology, KU Leuven – University of Leuven, Leuven, Belgium"
      ],
      "name": "Bart Morlion"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium",
        "Department of Experimental-Health Psychology, Faculty of Health Psychology, Ghent University, Ghent, Belgium"
      ],
      "name": "Marthe Van Overbeke"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium",
        "Department of Experimental-Health Psychology, Faculty of Health Psychology, Ghent University, Ghent, Belgium"
      ],
      "name": "Emma Tack"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium"
      ],
      "name": "Sophie Van Dijck"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, KU Leuven – University of Leuven, Leuven, Belgium",
        "Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium"
      ],
      "name": "Nele Devoogdt"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, KU Leuven – University of Leuven, Leuven, Belgium"
      ],
      "name": "Ceren Gursen"
    },
    {
      "affiliations": [
        "Department of Experimental-Health Psychology, Faculty of Health Psychology, Ghent University, Ghent, Belgium"
      ],
      "name": "Annick L De Paepe"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium",
        "Research School CAPHRI, Department of Rehabilitation Medicine, Maastricht University, Maastricht, The Netherlands"
      ],
      "name": "Michel Mertens"
    },
    {
      "affiliations": [
        "Department of Family Medicine and Population Health (FAMPOP), University of Antwerp, Antwerp, Belgium"
      ],
      "name": "Josefien van Olmen"
    },
    {
      "affiliations": [
        "Department of Family Medicine and Population Health (FAMPOP), University of Antwerp, Antwerp, Belgium"
      ],
      "name": "Lander Willem"
    },
    {
      "affiliations": [
        "Multidisciplinary Breast Clinic, Antwerp University Hospital, Antwerp, Belgium",
        "Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium"
      ],
      "name": "Wiebren Tjalma"
    },
    {
      "affiliations": [
        "Department of Surgical Oncology, University Hospital Leuven, Leuven, Belgium"
      ],
      "name": "Ines Nevelsteen"
    },
    {
      "affiliations": [
        "Department of Gynaecological Oncology, University Hospital Leuven, Leuven, Belgium"
      ],
      "name": "Patrick Neven"
    },
    {
      "affiliations": [
        "Department of Surgical Oncology, University Hospital Leuven, Leuven, Belgium"
      ],
      "name": "Rani Vanhoudt"
    },
    {
      "affiliations": [
        "Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium",
        "Multidisciplinary Pain Centre (PCT), University Hospital Antwerp, Wilrijk, Belgium"
      ],
      "name": "Davina Wildemeersch"
    },
    {
      "affiliations": [
        "IDLab, Department of Information Technology - imec, Ghent University, Ghent, Belgium"
      ],
      "name": "Femke De Backere"
    },
    {
      "affiliations": [
        "Department of Public Health, Interuniversity Center for Biostatistics and Statistical Bioinformatics, KU Leuven, Leuven, Belgium"
      ],
      "name": "Steffen Fieuws"
    },
    {
      "affiliations": [
        "Department of Experimental-Health Psychology, Faculty of Health Psychology, Ghent University, Ghent, Belgium"
      ],
      "name": "Geert Crombez"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium"
      ],
      "name": "Mira Meeus"
    }
  ],
  "title": "Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer survivors with persistent pain: the PECAN trial",
  "uid": "7a4c5cc3-df66-52f8-a661-95af7a77be90"
}