Breast Cancer, Breast Cancer Female
Conditions
Brief summary
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.
Detailed description
Breast cancer survivors frequently experience persistent pain, upper limb dysfunction, and CRF well into the survivorship phase, even after completion of acute treatment. Despite various studies evaluating individual interventions, long-term outcomes remain inconclusive due to heterogeneity and short follow-up durations (Devoogdt & De Groef, 2024; McNeely et al., 2010). This study proposes a standardized, multidisciplinary physiotherapy program that integrates: Specific Exercise Therapy: Structured stretching and strengthening sessions targeting UL mobility and overall fitness (30-60 minutes per session, three times weekly for 8 weeks under supervision, followed by individual home-based maintenance). Manual Therapy: Targeted soft-tissue mobilization and myofascial release (20-30 minutes per session, twice weekly for 4 weeks). Education: In-person and online sessions on pain neuroscience and self-management delivered in three sessions. Mind-Body Interventions: Yoga or tai chi sessions (40 minutes per session, once weekly for 6 weeks). In this multi-center, parallel-group design, 146 women (aged 18-65) who have undergone breast cancer surgery (with or without axillary lymph node dissection) and completed acute treatment, yet experience persistent sequelae, will be enrolled. Participants will be randomized into two groups: one receiving the multidisciplinary physiotherapy program and the other receiving standard care (routine follow-up with basic physiotherapy advice). Primary outcomes are measured by changes in pain intensity (VAS), upper limb function (DASH), and CRF (FACIT-Fatigue) at baseline, 3, 6, and 12 months. Secondary outcomes include quality of life (SF-36) and psychological well-being (HADS). Data will be analyzed using intention-to-treat principles with mixed-effects regression models to adjust for baseline covariates. This study will provide high-quality long-term data to potentially standardize physiotherapy care protocols for breast cancer survivors.
Interventions
BEHAVIORALMultidisciplinary Physiotherapy Program (MD Physio)
A comprehensive program that integrates: Specific Exercise Therapy: Supervised stretching and strengthening sessions (30-60 minutes/session, 3× per week for 8 weeks) followed by a prescribed home-based maintenance regimen. Manual Therapy: Targeted soft-tissue mobilization and myofascial release (20-30 minutes/session, twice per week for 4 weeks). Education Sessions: Three sessions (both in-person and online) covering pain neuroscience and self-management techniques. Mind-Body Interventions: Weekly 40-minute sessions of yoga or tai chi for 6 weeks.
BEHAVIORALStandard Physiotherapy Care
Routine care involves standard follow-up with basic physiotherapy advice as currently provided to breast cancer survivors. This serves as the active comparator in the trial.
Sponsors
Al Hayah University In Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the interventions, participants, care providers, and investigators will be aware of the treatment allocation; however, outcome assessors will remain blinded to reduce assessment bias.
Intervention model description
Participants will be randomized (stratified if necessary) to one of two groups-an intervention group receiving the multidisciplinary physiotherapy program and a control group receiving standard care. Both groups will be followed for 12 months to assess clinical and patient-reported outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Visual Analog Scale - VAS) | Baseline, 3 months, 6 months, and 12 months post-intervention. | The VAS is a 0-100 scale used to measure patient-reported pain intensity, where 0 indicates no pain and 100 indicates the worst imaginable pain. |
| Upper Limb Function (DASH Questionnaire) | Baseline, 3 months, 6 months, and 12 months post-intervention. | The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire assesses upper limb function and symptoms with higher scores indicating greater disability. |
| Cancer-Related Fatigue (FACIT-Fatigue) | Baseline, 3 months, 6 months, and 12 months post-intervention. | The FACIT-Fatigue scale is a validated tool used to assess the level of fatigue experienced by patients, with lower scores representing greater fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (SF-36 Health Survey) | Baseline, 3 months, 6 months, and 12 months post-intervention. | The SF-36 assesses overall health status across multiple domains, providing a composite measure of quality of life. |
| Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS) | Baseline, 3 months, 6 months, and 12 months post-intervention. | The HADS is used to evaluate anxiety and depression levels in participants, with higher scores indicating greater psychological distress. |
Countries
Egypt
Contacts
Primary ContactMohamed ElMeligie, Ph.D
Outcome results
None listed