Clinical trial · Interventional
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
- 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)
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
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eHealth self-management support program | Behavioral | — | UNRESOLVED |
| Face-to-face rehabilitation program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- eHealth self-management support program
- description
- This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle.
- interventionNames
- Behavioral: eHealth self-management support program
- type
- ACTIVE_COMPARATOR
- label
- Face-to-face rehabilitation program
- description
- The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist (recruited and trained by the research team) to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally (explanation by the therapist) and written (information leaflet, summaries, pictures, metaphors and diagrams on computer and paper). After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDe Groef A, Dams L, Moseley GL, Heathcote LC, Wiles LK, Catley M, Vogelzang A, Hibbert P, Morlion B, Van Overbeke M, Tack E, Van Dijck S, Devoogdt N, Gursen C, De Paepe AL, Mertens M, van Olmen J, Willem L, Tjalma W, Nevelsteen I, Neven P, Vanhoudt R, Wildemeersch D, De Backere F, Fieuws S, Crombez G, Meeus M. Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer survivors with persistent pain: the PECAN trial. BMJ Open. 2025 Aug 22;15(8):e099241. doi: 10.1136/bmjopen-2025-099241. PMID 40846340