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

March 30, 2025 updated by: Al Hayah University In Cairo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Recruiting
        • Faculty of Physical Therapy, Al Hayah University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidisciplinary Physiotherapy Program

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.
Behavioral: Multidisciplinary 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.
Active Comparator: Control - Standard Care
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.
Behavioral: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Visual Analog Scale - VAS)
Time Frame: 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.
Baseline, 3 months, 6 months, and 12 months post-intervention.
Upper Limb Function (DASH Questionnaire)
Time Frame: 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.
Baseline, 3 months, 6 months, and 12 months post-intervention.
Cancer-Related Fatigue (FACIT-Fatigue)
Time Frame: 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.
Baseline, 3 months, 6 months, and 12 months post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (SF-36 Health Survey)
Time Frame: 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.
Baseline, 3 months, 6 months, and 12 months post-intervention.
Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS)
Time Frame: 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.
Baseline, 3 months, 6 months, and 12 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Hayah University In Cairo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 23, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCPhysio2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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