scholarly journals The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review

10.2196/22006 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e22006
Author(s):  
Ulrikke Lyng Beauchamp ◽  
Helle Pappot ◽  
Cecilie Holländer-Mieritz
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Severe Disease ◽  
Vital Signs ◽  
Sensor Data ◽  
Special Focus ◽  
Oncological Treatment ◽  
Patient Reported

Background Interest in the 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 a special focus on adherence. Methods PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. 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 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. 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, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, 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. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.

scholarly journals The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Ulrikke Lyng Beauchamp ◽  
Helle Pappot ◽  
Cecilie Holländer-Mieritz
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Severe Disease ◽  
Vital Signs ◽  
Sensor Data ◽  
Special Focus ◽  
Oncological Treatment ◽  
Patient Reported

BACKGROUND Interest in the 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 a special focus on adherence. METHODS PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. 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 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. 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, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, 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. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.

scholarly journals Digital Health Applications for Pharmacogenetic Clinical Trials

Genes ◽  
2020 ◽  
Vol 11 (11) ◽  
pp. 1261
Author(s):  
Hetanshi Naik ◽  
Latha Palaniappan ◽  
Euan A. Ashley ◽  
Stuart A. Scott
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Digital Health ◽  
Clinical Care ◽  
Vital Signs ◽  
Medication Administration ◽  
Therapeutic Interventions ◽  
Participant Engagement ◽  
Patient Reported ◽  
Health Related

Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation.

P070 TRENDS AND CHARACTERISTICS OF CLINICAL TRIALS PARTICIPATION IN THE IBD PARTNERS COHORT

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S11-S12
Author(s):  
Cole Johnson ◽  
Edward Barnes ◽  
Xian Zhang ◽  
Millie Long
Keyword(s):  
Clinical Trials ◽  
Controlled Trial ◽  
Severe Disease ◽  
Drug Approval ◽  
Cross Sectional Study ◽  
Participation Rates ◽  
Cross Sectional ◽  
Mild Disease ◽  
Randomized Controlled ◽  
Study Results

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCT) for inflammatory bowel disease (IBD) which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors which could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an interventional randomized controlled trial (RCT) of a medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated an in RCT during each calendar year from 2011–2018 and Clinicaltrials.gov was accessed to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1,116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation (Table 1) included following at an academic institution (OR=1.8; 95%CI: 1.51–2.04) and age 36–75 (OR=1.6; 95%CI: 1.43–1.87). Patients with Crohn’s disease (CD) were more likely to participate than those with ulcerative colitis (UC) (OR=1.5; 95%CI: 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR=2.6; 95%CI: 2.19–2.99), IBD-related surgery (OR=2.5; 95%CI: 2.24–2.87), biologic exposure (OR=3.2; 95%CI: 2.76–3.65), and “Poor” or worse quality of life (OR=1.7; 95%CI: 1.45–1.93). Steroid-free remission was associated with lower likelihood of RCT participation (OR=0.6; 95%CI: 0.53–0.70). While the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort (Figure 1). Conclusions RCT participation rates declined within this cohort between 2011–2018. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean sCDAI and SCCAI scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-TNF exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

scholarly journals A supervised exercise intervention during cancer treatment for adolescents and young adults—FiGHTING F!T: study protocol of a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Claire Munsie ◽  
Jay Ebert ◽  
Joanne Collins ◽  
Megan Plaster ◽  
David Joske ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Adolescent And Young Adult ◽  
Exercise Tests ◽  
Supervised Exercise ◽  
Wide Range ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background High-quality evidence supports the integration of exercise to mitigate treatment-related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured, and progressive exercise programme can reduce the decline in physical fitness (V02peak) associated with cancer treatment in AYAs from diagnosis. Methods/design A total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0–10 weeks) or following an interim assessment to 20 weeks (10–20 weeks). The bi-weekly tailored exercise programme will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10, and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning, and self-reported quality of life measurements. Patient-reported treatment-related toxicities will be recorded on a weekly basis. Discussion The FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise programme in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort. Trial registration This trial was registered retrospectively with the Australia New Zealand Clinical Trial registry (ACTRN12620000663954). Registered on 10 June 2020

scholarly journals Effects Of Educational Intervention Based On Integrated Social Marketing Approach On Regular Physical Activity of Female Students: A Study Protocol For A Cluster Randomised Trial

2021 ◽  
Author(s):  
Babak Moeini ◽  
Forouzan Rezapur-Shahkolai ◽  
Rashid Heidarimoghadam ◽  
Leili Tapak ◽  
Azam Geravandi
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Social Marketing ◽  
Educational Intervention ◽  
Low Income ◽  
Primary Schools ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Regular Physical Activity ◽  
Control Group

Abstract Background: A sedentary lifestyle is recognized as a risk factor for chronic diseases. The aim of this study was to identify the factors related to regular physical activity in adolescents. Also design effective social marketing interventions on these factors in primary schools in Kermanshah (western Iran).Method: This study will be a parallel randomised controlled trial (RCT) conducted at a secondary school in Kermanshah. This protocol conforms to the Consolidated Standard of Reporting Trials (CONSORT) Statement and is registered at the Iranian Registry of Clinical Trials (IRCT:IRCT20200621047858N1). This research will be conducted in three phases that correspond to the first to seventh stages of the social marketing operational model, i.e. the SMART model. Given that this study is a three-stage study, an interventional study will be conducted to investigate the effect of educational intervention on regular physical activity behavior among female junior high school students. In this study, we will have an intervention group and a control group. In each area (north and south of the city), using the division by the school education department, is divided into three categories (rich, middle-income and low-income) and a simple random method is selected from each category of one school (3 intervention schools and 3 control schools. The sample size required for the intervention and control group is calculated as 108 people. Individuals are evaluated for regular physical activity according to the stages of behavior change before and after the intervention.Trial registration: IRAN Clinical Trials Register IRCT20200621047858N1 (date of registration: 2020/7/25 randomized controlled trial registered).Ethics approval: IR.UMSHA.REC.1398.952

Optimal Metamodeling to Interpret Activity-Based Health Sensor Data

2017 ◽  
Author(s):  
Souma Chowdhury ◽  
Ali Mehmani
Keyword(s):  
Physical Activity ◽  
Wearable Sensors ◽  
Vital Signs ◽  
Medical Diagnostics ◽  
Sensor Data ◽  
Sensitivity Testing ◽  
Data Set ◽  
Functional Relationships ◽  
Median Error ◽  
The Impact

Wearable sensors are revolutionizing the health monitoring and medical diagnostics arena. Algorithms and software platforms that can convert the sensor data streams into useful/actionable knowledge are central to this emerging domain, with machine learning and signal processing tools dominating this space. While serving important ends, these tools are not designed to provide functional relationships between vital signs and measures of physical activity. This paper investigates the application of the metamodeling paradigm to health data to unearth important relationships between vital signs and physical activity. To this end, we leverage neural networks and a recently developed metamodeling framework that automatically selects and trains the metamodel that best represents the data set. A publicly available data set is used that provides the ECG data and the IMU data from three sensors (ankle/arm/chest) for ten volunteers, each performing various activities over one-minute time periods. We consider three activities, namely running, climbing stairs, and the baseline resting activity. For the following three extracted ECG features — heart rate, QRS time, and QR ratio in each heartbeat period — models with median error of <25% are obtained. Fourier amplitude sensitivity testing, facilitated by the metamodels, provides further important insights into the impact of the different physical activity parameters on the ECG features, and the variation across the ten volunteers.

scholarly journals Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
Rater Reliability ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

scholarly journals An App With Brief Behavioural Support to Promote Physical Activity After a Cancer Diagnosis (APPROACH): Study Protocol for a Pilot Randomised Controlled Trial

2021 ◽  
Author(s):  
Phillippa Lally ◽  
Natalie Miller ◽  
Anna Roberts ◽  
Rebecca J Beeken ◽  
Diana M Greenfield ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Diagnosis ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Self Report ◽  
Brisk Walking ◽  
Behavioural Support ◽  
Patient Reported ◽  
Randomised Controlled

Abstract BackgroundThere are multiple health benefits from participating in physical activity after a cancer diagnosis, but many people living with and beyond cancer (LWBC) are not meeting physical activity guidelines. App-based interventions offer a promising platform for intervention delivery. This trial aims to pilot a theory-driven, app-based intervention that promotes brisk walking among people living with and beyond cancer. The primary aim is to investigate the feasibility and acceptability of study procedures before conducting a larger randomised controlled trial (RCT).MethodsThis is an individually randomised, two-armed pilot RCT. Patients with localised or metastatic breast, prostate or colorectal cancer, who are aged 16 years or over, will be recruited from a single hospital site in South Yorkshire in the UK. The intervention includes an app designed to encourage brisk walking (Active 10) supplemented with habit-based behavioural support in the form of two brief telephone/video calls, an information leaflet and walking planners. The primary outcomes will be feasibility and acceptability of the study procedures. Demographic and medical characteristics will be collected at baseline, through self-report and hospital records. Secondary outcomes for the pilot (assessed at 0 and 3 months) will be accelerometer measured and self-reported physical activity, body mass index (BMI) and waist circumference, and patient reported outcomes of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, and habit strength for walking. Qualitative interviews will explore experiences of participating or reasons for declining to participate. Parameters for the intended primary outcome measure (accelerometer measured average daily minutes of brisk walking (>100 steps/minute)) will inform a sample size calculation for the future RCT and a preliminary economic evaluation will be conducted. DiscussionThis pilot study will inform the design of a larger RCT to investigate the efficacy and cost-effectiveness of this intervention in people LWBC. Trial registrationISRCTN registry, ISRCTN18063498. Registered 16 April 2021. http://isrctn.com/ISRCTN18063498

Sign in / Sign up

Export Citation Format

Share Document