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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Physical Therapy, Al Hayah University
RECRUITING
Cairo
Contact Information
Primary
Mohamed ElMeligie, Ph.D
mohamed.elmeligie@ahuc.edu.eg
01159880001
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 146
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Al Hayah University In Cairo

This content was sourced from clinicaltrials.gov