NCT06308029 Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
| NCT ID | NCT06308029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-05-26 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2024-05-26 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion criteria * 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) Exclusion criteria * 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
Contact & Investigator
An De Groef, PhD
PRINCIPAL INVESTIGATOR
Universiteit Antwerpen
Frequently Asked Questions
Who can join the NCT06308029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308029 currently recruiting?
Yes, NCT06308029 is actively recruiting participants. Contact the research team at an.degroef@uantwerpen.be for enrollment information.
Where is the NCT06308029 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Leuven, Belgium.
Who is sponsoring the NCT06308029 clinical trial?
NCT06308029 is sponsored by Universiteit Antwerpen. The principal investigator is An De Groef, PhD at Universiteit Antwerpen. The trial plans to enroll 270 participants.
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