Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

Breast Cancer Clinical Trial

Official title:

Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152590
• Other study ID #: KC19EESI0325
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: May 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective pilot study. 20 breast cancer patients who underwent wide local excision-axillary lymph node diessection or modified radical mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

Description:

The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may suffer difficulty in activities of daily life and quality of life may be reduced.

Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.

The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who underwent breast cancer surgery (wide local excision-axillary lymph node dissection or modified radical mastectomy)

• Limited active/passive range of motion of the affected shoulder (Flexion <160' or Abduction <160')

• post-operative day not exceeding 8 week

• Patients who agreed informed consent

Exclusion Criteria:

• Bilateral breast cancer surgery

• Patients with shoulder pain of limited ROM before breast cancer surgery

• Those unable to perform exercise due to general deconditioning

• Those with communication difficulty

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Rehabilitation

Intervention

Device:
• Uincare
Interactive digital healthcare system

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JongIn Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion of affected shoulder	Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks	Enrollment, 4 week, 8 week, 12 week
Secondary	Numerical rating scale of affected shoulder	Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)	Enrollment, 4 week, 8 week, 12 week
Secondary	Functional outcome	Evaluation of shoulder function using Quick DASH	Enrollment, 4 week, 8 week, 12 week
Secondary	Quality of life of the patient with breast cancer	Evaluation of quality of life using FACT-B	Enrollment, 4 week, 8 week, 12 week
Secondary	Quality of life of the patient	Evaluation of quality of life using EQ-5D	Enrollment, 4 week, 8 week, 12 week