Clinical trial · Interventional
Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: Evaluation of the 12-Month Effectiveness on Pain, Upper Limb Function, and Cancer-Related Fatigue in a Multi-Center, Parallel-Group 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)
This multi-center randomized controlled trial (RCT) evaluates the long-term (12-month) effectiveness of a standardized multidisciplinary physiotherapy program versus standard care on persistent pain, upper limb (UL) dysfunction, and cancer-related fatigue (CRF) in breast cancer survivors. The study also examines improvements in quality of life and psychological well-being. The standardized intervention combines specific exercise therapy, manual therapy, education, and mind-body interventions and is designed to produce sustained benefits beyond the acute rehabilitation phase.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multidisciplinary Physiotherapy Program (MD Physio) | Behavioral | — | UNRESOLVED |
| Standard Physiotherapy Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multidisciplinary Physiotherapy Program
- description
- Participants in this arm will undergo a standardized multidisciplinary physiotherapy program consisting of: Specific Exercise Therapy: 30-60-minute sessions conducted thrice weekly for 8 weeks (supervised) with subsequent home-based maintenance. Manual Therapy: 20-30-minute soft-tissue mobilization sessions twice weekly for 4 weeks. Education: Three sessions (in-person and online) focusing on pain neuroscience and self-management strategies. Mind-Body Interventions: 40-minute yoga or tai chi sessions once weekly for 6 weeks.
- interventionNames
- Behavioral: Multidisciplinary Physiotherapy Program (MD Physio)
- type
- ACTIVE_COMPARATOR
- label
- Control - Standard Care
- description
- Participants in the control arm will receive "standard care" as currently practiced. This includes routine follow-up and basic physiotherapy advice typically provided to breast cancer survivors without the structured, multidisciplinary program.
- interventionNames
- Behavioral: Standard Physiotherapy Care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Women aged between 18 and 65 years. History of breast cancer surgery (with or without axillary lymph node dissection). Completed acute cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment. Currently in the survivorship phase, with no active evidence of disease. Experiencing persistent sequelae related to treatment, such as: Moderate to severe pain (e.g., VAS score ≥ 30 on a 0-100 scale), and/or Upper limb dysfunction, and/or Cancer-related fatigue (as measured by FACIT-Fatigue). Able to understand and provide written informed consent. Exclusion Criteria: Diagnosis of recurrent or metastatic breast cancer. Currently receiving active cancer treatment (chemotherapy, radiation for active disease, or immunotherapy). Participation in another interventional trial targeting pain or rehabilitation within the past 3 months. Presence of severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic or neurological conditions) that would preclude safe participation in physiotherapy. Any physical or psychological condition that, in the opinion of the investigator, would interfere with participation or adherence to the study protocol (e.g., severe cognitive impairment). Pregnancy or breastfeeding.
References
Publications (0)
Data not yet available