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

NCT06913244 | Recruiting

• 1 other identifier: BCPhysio2025-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer Female

Outcome Measures

Primary Outcomes (3)

• Pain Intensity (Visual Analog Scale - VAS)

  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)

  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)

  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 Outcomes (2)

• Quality of Life (SF-36 Health Survey)

  Baseline, 3 months, 6 months, and 12 months post-intervention.

• Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS)

  Baseline, 3 months, 6 months, and 12 months post-intervention.

Study Arms (2)

Multidisciplinary Physiotherapy Program

EXPERIMENTAL

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)

Control - Standard Care

ACTIVE COMPARATOR

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

Interventions

Multidisciplinary Physiotherapy Program (MD Physio) BEHAVIORAL

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.

Multidisciplinary Physiotherapy Program

Standard Physiotherapy Care BEHAVIORAL

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.

Control - Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohamed ElMeligie, Ph.D

CONTACT

01159880001; mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)