Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Recruiting now · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06308029
- Run by
- Universiteit Antwerpen
- People needed
- 270
- Starts
- 2024-05-26
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2025-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Do not speak/understand Dutch
Where it is running
- Universiteit Antwerpen — Antwerp, Belgium (enrolling)
- KU Leuven — Leuven, Belgium (enrolling)
Full record on ClinicalTrials.gov
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