LYMPH-V: A Wearable Arm Volume Measurement Device and Mobile Application for the Prevention and Early Detection of Breast Cancer-Related Lymphedema: a Study Protocol

Abstract

Objective

This study aims to develop a wearable arm measurement device and mobile application for the prevention and early detection of lymphoedema and evaluation of their efficacy.

Methods

This is a two-phase mixed method study including two qualitative study, reproducibility study, and a pilot randomized controlled trial. The first phase is the development of the arm volume measuring device and mobile application, and the second phase is the evaluation of the effectiveness of the products. The mobile application will consist of five sections focusing on the prevention and early detection of breast cancer-related lymphedema: (I) exercise, (II) education, (III) coping mechanisms, (IV) arm volume measurement/recording, and (V) reminder for exercise, measurement, and follow-up. Exercise videos and educational content will be developed based on the current guidelines and revised according to expert opinion. A qualitative design will identify patients' problems and coping mechanisms related to lymphedema. The arm volume measurement device will be developed using stretch sensors. In evaluating the effectiveness of the products, a pilot RCT, a reproducibility study, and patient feedback will be used as a basis. This study was supported by the Scientific and Technological Research Council of Türkiye (TUBITAK) (Grant Number 223S524).

Conclusion

This study will contribute to the wellbeing of cancer survivors by enabling the prevention and early detection of lymphedema, and to the healthcare professionals by enabling the regular follow-up of limb volume without the necessity of a hospital visit.