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

NCT04152590 | Completed

• 1 other identifier: KC19EESI0325
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Numerical rating scale of affected shoulder

  Enrollment, 4 week, 8 week, 12 week

• Functional outcome

  Enrollment, 4 week, 8 week, 12 week

• Quality of life of the patient with breast cancer

  Enrollment, 4 week, 8 week, 12 week

• Quality of life of the patient

  Enrollment, 4 week, 8 week, 12 week

Study Arms (1)

Uincare

EXPERIMENTAL

Exercise using Uincare

Device: Uincare

Interventions

Uincare DEVICE

Interactive digital healthcare system

Uincare

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JongIn Lee: lead

Study Sites (1)

Seoul St Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jong In Lee, MD PhD

  Seoul St. Mary's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: October 21, 2019
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

KR (1)