Clinical trial NCT04152590: Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Rehabilitation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of motion of affected shoulder
timeFrame: Enrollment, 4 week, 8 week, 12 week
Secondary outcomes:
measure: Numerical rating scale of affected shoulder
timeFrame: Enrollment, 4 week, 8 week, 12 week
measure: Functional outcome
timeFrame: Enrollment, 4 week, 8 week, 12 week
measure: Quality of life of the patient with breast cancer
timeFrame: Enrollment, 4 week, 8 week, 12 week
measure: Quality of life of the patient
timeFrame: Enrollment, 4 week, 8 week, 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Jong In Lee, MD PhD
role: STUDY_CHAIR
References: