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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: rehabilitation

• Registration Number: NCT04894565
• Lead Sponsor: King Fahad Medical City

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

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-06-30
• Study Completion: 2021-02-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• women with breast cancer who require surgical resection

Exclusion Criteria

• in ability to undergo 3 months of physical therapy program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	rehabilitation	effect of rehabilitation program in the intervention arm

Primary Outcome Measures

Name	Time	Method
Shoulder/Arm 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).	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)
Quality of Life (QoL)	The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).	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)
Shoulder mobility	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 (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.
Handgrip strength	The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).	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.
Disabilities in daily life	The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).	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)

Secondary Outcome Measures

Name	Time	Method
Establishing firmly study feasibility	3 months	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.

Trial Locations

Locations (1)

KFMC; 🇸🇦 Riyadh, Saudi Arabia