Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
NCT ID: NCT06913244
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
146 participants
INTERVENTIONAL
2025-04-23
2027-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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 Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Al Hayah University In Cairo
OTHER
Responsible Party
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Locations
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Faculty of Physical Therapy, Al Hayah University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCPhysio2025-01
Identifier Type: -
Identifier Source: org_study_id
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