Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- women with breast cancer who require surgical resection
Exclusion Criteria:
- in ability to undergo 3 months of physical therapy program
Sites / Locations
- KFMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
effect of rehabilitation program in the intervention arm
Outcomes
Primary Outcome Measures
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)
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.
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)
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.
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04894565
Brief Title
Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
Official Title
Effectiveness of Home-based and Early Institutional Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Fahad Medical City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
pilot study on physical therapy in women with breast cancer immediately following surgery
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutive women with breast cancer who underwent breast cancer surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
effect of rehabilitation program in the intervention arm
Intervention Type
Procedure
Intervention Name(s)
rehabilitation
Intervention Description
physical therapy 24 hrs after surgery
Primary Outcome Measure Information:
Title
Shoulder/Arm Pain
Description
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)
Time Frame
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Title
Shoulder mobility
Description
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.
Time Frame
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Title
Disabilities in daily life
Description
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)
Time Frame
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Title
Handgrip strength
Description
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.
Time Frame
The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Title
Quality of Life (QoL)
Description
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)
Time Frame
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 Measure Information:
Title
Establishing firmly study feasibility
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with breat cancer
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with breast cancer who require surgical resection
Exclusion Criteria:
in ability to undergo 3 months of physical therapy program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noura Binsaad, MD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
KFMC
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
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