BACKGROUND: After receiving breast cancer surgery or reconstruction, shoulder dysfunctions including weakness, post-operative pain, shoulder joint instability, and limited range of motion (ROM) often occur. Due to limited ROM, patients may suffer difficulty in activities of daily living, and quality of life may be reduced. The objective of this study is to compare the effects on shoulder ROM of a real-time interactive digital healthcare system and brochure-based home rehabilitation program in post-operative breast cancer patients. METHODS: This study is a prospective, multi-center, assessor-blinded randomized controlled trial. The study aims to recruit 100 breast cancer patients exhibiting limited shoulder ROM after undergoing axillary lymph node dissection or breast reconstruction following mastectomy. Patients will be randomly assigned to two groups for 8 weeks of rehabilitation: a digital healthcare system rehabilitation (intervention) group and a brochure-based rehabilitation (control) group. The primary outcome is the change in ROM of the affected shoulder between baseline and 12 weeks after enrollment. Secondary outcomes include pain in the affected shoulder, as measured using a numerical rating scale, functional outcomes (QuickDASH scores), and quality of life (FACT-B and EQ-5D-5L scores), all of which will be measured on enrollment and 4, 8, and 12 weeks thereafter. DISCUSSION: This study will compare the effectiveness of a newly developed, augmented reality-based real-time interactive digital healthcare system with that of brochure-based home rehabilitation for improving the shoulder ROM, pain, functional outcomes, and quality of life of post-operative breast cancer patients. TRIAL REGISTRATION: ClinicalTrials.govNCT04316156. Registered on 20 March 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05535-8.
Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial