Clinical trial NCT04316156: Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-03-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Range of motion in 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 (Quick Disability of Arm, Shoulder, Hand)
timeFrame: Enrollment, 4 week, 8 week, 12 week
measure: Quality of life in the patient with breast cancer (1)
timeFrame: Enrollment, 4 week, 8 week, 12 week
measure: Quality of life in the patient with breast cancer (2)
timeFrame: Enrollment, 4 week, 8 week, 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
state: Seocho-gu
Study officials:
affiliation: Physical & Rehabilitation Medicine Samsung Medical Center
name: JIHYE HWANG, Professor
role: STUDY_CHAIR
References:
citation: Park HY, Nam KE, Lim JY, Yeo SM, In Lee J, Hwang JH. Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Aug 19;22(1):549. doi: 10.1186/s13063-021-05535-8.