Actively Recruiting
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Led by Universiteit Antwerpen · Updated on 2025-06-26
270
Participants Needed
2
Research Sites
240 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy)
- Non-metastatic breast cancer and finished primary treatment with curative intent at least 3 months prior to participation
- Adjuvant hormonal therapy and immunotherapy are allowed
- Presence of self-reported persistent pain in the last 3 months that interferes with daily activities
You will not qualify if you...
- Unable to participate for the entire study period
- Mentally or physically unable to participate in the study
- Previous participation in a pain science education program
- No access to a digital device
- Do not speak or understand Dutch
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Universiteit Antwerpen
Antwerp, Belgium
Actively Recruiting
2
KU Leuven
Leuven, Belgium
Actively Recruiting
Research Team
A
An De Groef, PhD
CONTACT
L
Lore Dams, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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