Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial

Al Hayah University In Cairo

Status: Enrolling

Conditions: Breast Cancer; Breast Cancer Female

Treatments: Behavioral: Multidisciplinary Physiotherapy Program (MD Physio); Behavioral: Standard Physiotherapy Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06913244

BCPhysio2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Multidisciplinary Physiotherapy Program

Experimental group

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.

Treatment:

Behavioral: Multidisciplinary Physiotherapy Program (MD Physio)

Control - Standard Care

Active Comparator group

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.

Treatment:

Behavioral: Standard Physiotherapy Care