RecruitingNot ApplicableNCT06913244

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

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


Sponsor

Al Hayah University In Cairo

Enrollment

146 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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.


Locations(1)

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt

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NCT06913244


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