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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894565
• Other study ID #: 18-115
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2021
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

pilot study on physical therapy in women with breast cancer immediately following surgery

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 1, 2021
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women with breast cancer who require surgical resection

Exclusion Criteria:

• in ability to undergo 3 months of physical therapy program

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• rehabilitation
physical therapy 24 hrs after surgery

Locations

Country	Name	City	State
Saudi Arabia	KFMC	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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