About this trial
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 society 3. 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.
Eligibility criteria
Qualifiers
Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);
Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;
Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;
Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes/no)
Disqualifiers
Can not participate during the entire study period;
Mentally or physically unable to participate in the study;
Previous participation in a pain science education program.
No acces to a digital device
Trial design
Treatments tested in this trial
- eHealth self-management support program
- Face-to-face rehabilitation program
Treatment groups
Sponsors and collaborators
Universiteit Antwerpen
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
University Ghent
Collaborator
KU Leuven
Collaborator
University Hospital, Antwerp
Collaborator