Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial

Study Overview
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Brief Summary
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pilot study on physical therapy in women with breast cancer immediately following surgery

Detailed Description
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A pilot, single-arm non-randomized clinical trial was conducted between the period September 2018 and June 2019 on a convenient sample of BC women. Primary study outcomes were pain, disabilities of the Arm, Shoulder, and Hand (DASH), handgrip strength, and quality of life (QoL). The secondary outcome was to assess the feasibility of this pilot study. All outcomes were recorded at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90) under standardized conditions. The interventions were delivered by the physiotherapist early within 24 hours post-operatively, T1, and T2. In addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance

Official Title
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Effectiveness of Home-based and Early Institutional Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with breast cancer who require surgical resection Exclusion Criteria: in ability to undergo 3 months of physical therapy program
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Consecutive women with breast cancer who underwent breast cancer surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>effect of rehabilitation program in the intervention arm | Procedure: rehabilitation<br>* physical therapy 24 hrs after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder/Arm Pain | Pain in the shoulder/arm was assessed using the visual analogue scale (VAS) with a scoring system of 0-10 (0 = no pain; 1-3; mild pain, 4-6; moderate pain, 7-10 severe pain) | The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90). | 
| Shoulder mobility | Shoulder mobility (flexion [0-180°], abduction [0-180°]) was measured by using a digital inclinometer under standardized conditions. Patients were maintained in a seated position for all movements to minimize compensatory movements of the trunk. | The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90). | 
| Disabilities in daily life | by using Quick DASH scale (Disabilities of the Arm, Shoulder, and Hand) questionnaire. The Quick DASH consists of 11 items that allow for cumulative and multiple assessments of a patient over time, and each item has 5 response options. According to the Quick DASH scale scoring system, the scale scores are calculated and ranging from 0 (no functional disability) to 100 (most severe disability) | The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90). | 
| Handgrip strength | measured while the patient stabilized in a seated position with the elbow in 90 degrees of flexion and squeezes three times the dynamometer with each hand. | The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90). | 
| Quality of Life (QoL) | Patients' QoL was assessed by using the Functional Assessment of Cancer Therapy-General (FACT-G) scale. FACT-G (version-4) is a validated, self-reported multi-dimensional, 27-items questionnaire measuring QoL for breast cancer patients with 1 4-points Likert scale (0-108). The FACT-G comprises of 4-subscales: Physical Well-being (PWB: 7-items; score range 0 to 28), Social Well-being (SWB: 7-items; score range 0 to 28), Emotional Well-being (EWB: 6-items; score range 0 to 24), Functional Well-being (FWB: 7-items; score range 0 to 28) | The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing firmly study feasibility | Assess for clinical effect size (ES) worth investigation, sample recruitment strategy, adherence to study protocol, and adverse events in preparation to conduct a larger definitive study. | 3 months |