Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Multidisciplinary Physiotherapy Program (MD Physio)
BehavioralA 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.
Standard Physiotherapy Care
BehavioralRoutine 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.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Multidisciplinary Physiotherapy ProgramExperimental treatment 1 intervention
Group B: Control - Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-intervention.2
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-intervention.3
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-intervention.Secondary outcomes
1
Quality of Life (SF-36 Health Survey)
The SF-36 assesses overall health status across multiple domains, providing a composite measure of quality of life.
Time frame
Baseline, 3 months, 6 months, and 12 months post-intervention.2
Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS)
The HADS is used to evaluate anxiety and depression levels in participants, with higher scores indicating greater psychological distress.
Time frame
Baseline, 3 months, 6 months, and 12 months post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov