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

NCT04894565 | Completed

• 1 other identifier: 18-115
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Establishing firmly study feasibility

  3 months

Study Arms (1)

intervention

EXPERIMENTAL

effect of rehabilitation program in the intervention arm

Procedure: rehabilitation

Interventions

rehabilitation PROCEDURE

physical therapy 24 hrs after surgery

intervention

Eligibility Criteria

• Gender Eligibility Details: women with breat cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women with breast cancer who require surgical resection

You may not qualify if:

• in ability to undergo 3 months of physical therapy program

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

KFMC

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Noura Binsaad, MD

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Consecutive women with breast cancer who underwent breast cancer surgery

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 20, 2021
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: February 1, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

SA (1)