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Completed

NCT Number: NCT04316156

Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial

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 study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following 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 Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Seoul, Gangnam-gu, South Korea

Loading trial locations.

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 have difficulty with 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 (axillary lymph node dissection or breast reconstruction following 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 and limited ROM before breast cancer surgery
  • Those unable to perform exercise due to general deconditioning
  • Those with communication difficulty

Treatment and study plan

Uincare Homeplus

Device

Interactive digital healthcare system

Other names: digital healthcare

brochure

Other

Brochure

Primary outcomes

  1. Range of motion in affected shoulder

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

    Evaluation of change in 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 in the affected shoulder using numerical rating scale minimum ~ maximum value: 0 ~ 10, higher scores mean worse outcome.

  2. Functional outcome (Quick Disability of Arm, Shoulder, Hand)

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

    Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability).

  3. Quality of life in the patient with breast cancer (1)

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

    Evaluation of quality of life using Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) The total FACT-B score ranges from 0 to 123, and is calculated by adding the scores from each of these subscales. Lower scores indicate better health.

  4. Quality of life in the patient with breast cancer (2)

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

    Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means the worst quality of life you can imagine.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Ministry of Health, Republic of Korea

Registry information

Official study title

Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial, Assessor Blinding, Multi-center Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Dec 16, 2021

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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