Dataset Information

Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial.

ABSTRACT:

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.gov NCT04316156 . Registered on 20 March 2020.

SUBMITTER: Park HY

PROVIDER: S-EPMC8374413 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background: Stress is a complex phenomenon that may have a negative influence on health and well-being; consequently, it plays a pivotal role in mental health. Although the incidence of mental disorders has been continuously rising, development of prevention and treatment methods has been rather slow. Through the ubiquitous presence of smartphones and wearable devices, people can monitor stress parameters in everyday life. However, the reliability and validity of such monitoring are still unsatisfactory. Methods: The aim of this trial is to find a relationship between psychological stress and saliva cortisol levels on the one hand and physiological parameters measured by smartphones in combination with a commercially available wearable device on the other. Participants include cohorts of individuals with and without a psychiatric disorder. The study is conducted in two settings: one naturalistic and one a controlled laboratory environment, combining ecological momentary assessment (EMA) and digital phenotyping (DP). EMA is used for the assessment of challenging and stressful situations coincidentally happening during a whole observation week. DP is used during a controlled stress situation with the Trier Social Stress Test (TSST) as a standardized psychobiological paradigm. Initially, participants undergo a complete psychological screening and profiling using a standardized psychometric test battery. EMA uses a smartphone application, and the participants keep a diary about their daily routine, activities, well-being, sleep, and difficult and stressful situations they may encounter. DP is conducted through wearable devices able to continuously monitor physiological parameters (i.e., heart rate, heart rate variability, skin conductivity, temperature, movement and acceleration). Additionally, saliva cortisol samples are repeatedly taken. The TSST is conducted with continuous measurement of the same parameters measured during the EMA. Discussion: We aim to identify valid and reliable digital biomarkers for stress and stress reactions. Furthermore, we expect to find a way of early detection of psychological stress in order to evolve new opportunities for interventions reducing stress. That may allow us to find new ways of treating and preventing mental disorders. Trial Registration: The competing ethics committee of the Canton of Zurich, Switzerland, approved the study protocol V05.1 May 28, 2019 [BASEC: 2019-00814]; the trial was registered at ClinicalTrials.gov [NCT04100213] on September 19, 2019.