NCT06913244

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Al Hayah University In Cairo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer
• Breast Cancer Female

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-04-23
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Egypt