protocolSection identificationModule nctId: NCT06308029, orgStudyIdInfo id: Edge003203, secondaryIdInfos id: T001122N, type: OTHER_GRANT, domain: Research Foundations Flanders, secondaryIdInfos id: s68058, type: OTHER, domain: UZ/KU Leuven ID, briefTitle: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment, acronym: PECAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: Universitaire Ziekenhuizen KU Leuven, collaborators name: University Ghent, collaborators name: KU Leuven, collaborators name: University Hospital, Antwerp, descriptionModule briefSummary: The scientific goals of the project are:1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:   * usual care (i.e. superiority of the eHealth self-management support program) and   * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)   on pain-related disability (measured with the Pain Disability Index).2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:   * Other dimensions of pain   * Health-related quality of life   * Physical functioning, including physical activity levels   * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence   * Participation in society, including return to work   * Healthcare-related costs for the patient and society3. The tertiary scientific objectives of this study are   * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.   * To examine the implementation process, mechanisms of impact and contextual factors., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pragmatic randomized, multi-centric, three-arm controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: eHealth self-management support program, interventions name: Face-to-face rehabilitation program, outcomesModule primaryOutcomes measure: Pain-related disability, secondaryOutcomes measure: Pain related disability, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Severity of neuropathic Pain, secondaryOutcomes measure: Medication use, secondaryOutcomes measure: Pain location, secondaryOutcomes measure: Knowledge of neurophysiology of pain, secondaryOutcomes measure: Physical Activity pattern, secondaryOutcomes measure: Physical functioning, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Sleep disturbance, secondaryOutcomes measure: Pain Beliefs, secondaryOutcomes measure: Pain-related worrying, secondaryOutcomes measure: Vigilance to bodily sensations, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Determinants for physical activity, secondaryOutcomes measure: Participation, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Return to work rate, secondaryOutcomes measure: Medical costs of medical consumption, secondaryOutcomes measure: Indirect costs related to disease outside health care, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Patient Global Impression of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universiteit Antwerpen, status: RECRUITING, city: Antwerpen, country: Belgium, contacts name: An De Groef, PhD, role: CONTACT, email: an.degroef@uantwerpen.be, contacts name: Lore Dams, PhD, role: CONTACT, email: lore.dams@uantwerpen.be, geoPoint lat: 51.21989, lon: 4.40346, locations facility: KU Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Nele Devoogdt, PhD, role: CONTACT, email: nele.devoogdt@kuleuven.be, contacts name: An De Groef, PhD, role: CONTACT, email: an.degroef@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False