Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jul 2, 2020
Date Accepted: Sep 7, 2020
The use of wearables in clinical trials during cancer treatment: a review
ABSTRACT
Background:
The interest in use of wearables in medical care is increasing. Wearables can be used to monitor different variables such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology.
Objective:
The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment with special focus on adherence.
Methods:
PubMed and EMBASE databases were searched from October 3rd 20192019 and backward without any date limit. The search strategy was aimed at studies using wearables for monitoring adult cancer patients during active anti-neoplastic treatment. Studies were screened by title and abstract independently by two reviewers, selected for in-/exclusion and full-text assessed for eligibility by two reviewers. Data on study design, type of wearable used, primary outcome, adherence and device outcome were extracted. Results were presented descriptively.
Results:
Our systematic search identified 992 studies of which 25 studies met our inclusion criteria’s. The cancer types represented in the studies were breast (n=7), gastro-intestinal (n=4), lung (n=4), gynaecologic (n=1), nine studies had multiple cancer types. Oncologic treatment was primarily chemotherapy (n=16). Study type distribution was; pilot/feasibility study (n=12), observational study (n=10), randomized controlled trial (n=3). Median sample size were 40 patients (7-180). All studies used a wearable with an accelerometer. Adherence varied from 60-100% (patients wearing the wearable/evaluable sensor data) and 45-94%(evaluable days), across studies but was differently measured and reported. The most frequent planed monitoring duration with a wearable was 8-30 days (n=13). Topics for wearable outcome were; physical activity (n=18), circadian rhythm (n=8), sleep (n=6), skin temperature (n=2). Sixteen studies also used patient reported outcomes; quality of life (n=9), physical activity (n=7), mental health (n=7), specific symptom monitoring (n=7), others (n=7).
Conclusions:
We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity and better consensus in terms of use of wearables and establishing standards for definitions of wearable outcome and adherence, would improve comparisons of outcomes from studies using wearables. Adherence and definition of this seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment especially randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice. Clinical Trial: PROSPERO ID No. CRD42020154386
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