Clinical trial NCT06913244: Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity (Visual Analog Scale - VAS)
timeFrame: Baseline, 3 months, 6 months, and 12 months post-intervention.
measure: Upper Limb Function (DASH Questionnaire)
timeFrame: Baseline, 3 months, 6 months, and 12 months post-intervention.
measure: Cancer-Related Fatigue (FACIT-Fatigue)
timeFrame: Baseline, 3 months, 6 months, and 12 months post-intervention.
Secondary outcomes:
measure: Quality of Life (SF-36 Health Survey)
timeFrame: Baseline, 3 months, 6 months, and 12 months post-intervention.
measure: Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS)
timeFrame: Baseline, 3 months, 6 months, and 12 months post-intervention.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: