Clinical trial · Interventional
Effectiveness of a Modern Educational Intervention in Breast Cancer Patients
The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modern educational program | Other | — | UNRESOLVED |
| Standard physical therapy program | Other | — | UNRESOLVED |
| Traditional biomedical educational program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Standard physical therapy program + Modern educational program
- interventionNames
- Other: Standard physical therapy program
- Other: Modern educational program
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Standard physical therapy program + Traditional biomedical educational program
- interventionNames
- Other: Standard physical therapy program
- Other: Traditional biomedical educational program
Primary outcomes (1)
- measure
- Self-reported Change in Pain-related Disability
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients with primary breast cancer * Unilateral surgery including, either: Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery Exclusion Criteria: * Active metastasis * Cannot participate during the entire study period
References
Publications (5)
- BACKGROUNDDe Groef A, Devoogdt N, Van der Gucht E, Dams L, Bernar K, Godderis L, Morlion B, Moloney N, Smeets A, Van Wilgen P, Meeus M. EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning. BMJ Open. 2019 Jan 4;9(1):e025742. doi: 10.1136/bmjopen-2018-025742. PMID 30612114
- RESULTDams L, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, Haenen V, De Vrieze T, Fieuws S, Moloney N, Van Wilgen P, Meeus M, De Groef A. Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial). Pain. 2023 Jul 1;164(7):1489-1501. doi: 10.1097/j.pain.0000000000002838. Epub 2022 Dec 8. PMID 36637138
- RESULTDams L, Van der Gucht E, Haenen V, Devoogdt N, Smeets A, Bernar K, Morlion B, Moloney N, Fieuws S, De Groef A, Meeus M. Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial. Anat Rec (Hoboken). 2024 Feb;307(2):248-272. doi: 10.1002/ar.25127. Epub 2023 Jan 3. PMID 36594663
- RESULTDe Groef A, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, De Vrieze T, Fieuws S, Meeus M, Dams L. Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education. J Occup Rehabil. 2023 Dec;33(4):757-765. doi: 10.1007/s10926-023-10103-9. Epub 2023 May 12. PMID 37171771
- DERIVEDAmber G, Lore D, Elien VG, Jan S, Michel M, An G, Mira M. From breast cancer diagnosis to survivorship: Analyzing perioperative biopsychosocial phenotypes and their relationship to pain on long term. J Pain. 2025 Jan;26:104709. doi: 10.1016/j.jpain.2024.104709. Epub 2024 Oct 16. PMID 39419367