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NCT Number: NCT04152590

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Rehabilitation Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St Mary's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uincare

Device

Interactive digital healthcare system

Primary outcomes

  1. Range of motion of affected shoulder

    Time frame: Enrollment, 4 week, 8 week, 12 week

    Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks

Secondary outcomes

  1. Numerical rating scale of affected shoulder

    Time frame: Enrollment, 4 week, 8 week, 12 week

    Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)

  2. Functional outcome

    Time frame: Enrollment, 4 week, 8 week, 12 week

    Evaluation of shoulder function using Quick DASH

  3. Quality of life of the patient with breast cancer

    Time frame: Enrollment, 4 week, 8 week, 12 week

    Evaluation of quality of life using FACT-B

  4. Quality of life of the patient

    Time frame: Enrollment, 4 week, 8 week, 12 week

    Evaluation of quality of life using EQ-5D

Sponsors and collaborators

Lead sponsor

JongIn Lee

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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