scholarly journals Feasibility of Wearable Physical Activity Monitors in Patients With Cancer

2018 ◽  
pp. 1-10 ◽  
Author(s):  
Arjun Gupta ◽  
Tyler Stewart ◽  
Nizar Bhulani ◽  
Ying Dong ◽  
Zain Rahimi ◽  
...  

Purpose The feasibility of using physical activity monitors (PAMs) to measure functional status in patients with cancer is unclear. We aimed to determine the feasibility of using PAMs to longitudinally assess physical activity and performance status (PS) in patients with cancer. Methods Patients with cancer who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and were receiving systemic therapy were enrolled in a prospective pilot trial of PAM use. Feasibility was defined as patients using the PAM for > 50% of the observation period. We correlated PAM-reported measures with scores from ECOG PS and quality-of-life tools (Functional Assessment of Cancer Therapy–General [FACT-G], Quick Inventory of Depressive Symptoms–Self-Rated 16 [QIDS-SR16], and Brief Fatigue Inventory [BFI]) using Pearson’s correlation test. Patients were surveyed regarding their experience with PAMs at study completion. Results In all, 24 patients were enrolled; mean age was 54 years, 16 (67%) were women, and 19 (79%) were white. Twenty-three patients (96%) met the primary end point of feasibility. The median duration of follow-up was 69 days. Mean PAM-measured steps for ECOG PS of 0, 1, and 2 were 5,911, 1,890, and 845 steps per day, respectively ( P = .002). Minimum steps per day correlated with BFI ( r = –0.53; P < .01), FACT-G ( r = 0.45; P = .02), and QIDS-SR16 ( r = –0.57; P < .01). Eighteen patients (75%) reported a positive experience with the PAM. Conclusion PAMs are a feasible tool for measuring long-term physical activity in patients with cancer who are receiving systemic therapy. PAM-derived measures correlated with clinician-assessed PS.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6577-6577
Author(s):  
Muhammad Shaalan Beg ◽  
Tyler Stewart ◽  
Arjun Gupta ◽  
Ying Dong ◽  
Zain Rahimi ◽  
...  

6577 Background: Wearable physical activity monitors (PAMs) provide a degree of functional assessment not possible with prior clinical instruments. Subjective assessments of functional status are prone to inaccuracy and current objective assessment techniques are limited to the research setting. The relevance of physical activity monitors (PAMs) to measure functional status in cancer patients is unclear. The feasibility of using these devices in cancer patients is not known. Methods: This is a prospective pilot trial of a commercially available PAM in cancer patients. Patients with Eastern Cooperative Group performance status (ECOG PS) 0-2 receiving systemic therapy at an NCI Designated Comprehensive Cancer Center were enrolled. (NCT02583815). The primary objective was to determine feasibility of PAM use, defined as device use of more than 50% of the study observation period. Secondary objectives were to correlate PAM-reported measures: median, minimum and maximum steps/day, minutes of activity/day, (light/ fairly active/ very active); with 1) clinician assessed ECOG PS and 2) quality of life tool scores (FACT-G, QIDS, PQSI and BFI). Patient experience with wearable PAMs was assessed at the end of study. Results: We enrolled 32 patients: median age = 56 years (range 23-72), female = 67%, and white = 78%. Most patients had gastrointestinal (52%) and breast (19%) primaries. Clinician assessed PS was ECOG 0 in 56%, 1 in 37% and 2 in 7%. Majority of patients (81%) met the primary end point. Mean PAM measured steps for ECOG 0 was 5911 steps/d, ECOG 1 was 1890 steps/d and ECOG 2 was 845 steps/d (p = 0.002). Minimum steps/day correlated with BFI (r = -0.56, p < .01), FACT-G (r = 0.45, p 0.01) and QIDS (no vs mild vs moderate depression, p 0.01). Patients reported a positive experience with the devices (74%). Conclusions: Wearable PAMs are a feasible tool to measure physical activity in cancer patients receiving systemic therapy. PAM derived measures correlate with clinician assessments of performance status. Future work should develop methods to systematically incorporate PAMs in oncology clinical trials and practice. Clinical trial information: NCT02583815.


2017 ◽  
Vol 13 (2) ◽  
pp. 82-89 ◽  
Author(s):  
Muhammad S. Beg ◽  
Arjun Gupta ◽  
Tyler Stewart ◽  
Chad D. Rethorst

Commercially available physical activity monitors provide clinicians an opportunity to obtain oncology patient health measures to an unprecedented degree. These devices can provide objective and quantifiable measures of physical activity, which are not subject to errors or bias of self-reporting or shorter duration of formal testing. Prior work on so-called quantified-self data was based on older-generation, research-grade accelerometers, which laid the foundation for consumer-based physical activity monitoring devices to be validated as a feasible and reliable tool in patients with cancer. Physical activity monitors are being used in chronic conditions including chronic obstructive pulmonary disease, congestive heart failure, diabetes mellitus, and obesity. Differing demographics, compounded with higher symptom and treatment burdens in patients with cancer, imply that additional work is needed to understand the unique strengths and weaknesses of physical activity monitors in this population. Oncology programs can systematically implement these tools into their workflows in an adaptable and iterative manner. Translating large amounts of data collected from an individual physical activity monitoring device into clinically relevant information requires sophisticated data compilation and reduction. In this article, we summarize the characteristics of older- and newer-generation physical activity monitors, review the validation of physical activity monitors with respect to health-related quality-of-life assessments, and describe the current role of these devices for the practicing oncologist. We also highlight the challenges and next steps needed for physical activity monitors to provide relevant information that can change the current state of oncology practice.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 62-62 ◽  
Author(s):  
William F. Pirl ◽  
Daisuke Fujisawa ◽  
Jamie Stagl ◽  
Justin Eusebio ◽  
Lara Traeger ◽  
...  

62 Background: Treatment decisions are often based on performance status (PS), a subjective rating of patient functioning derived from observation and patient-report. Devices that monitor physical activity, such as wrist actigraphs, can accurately measure the percent of time a person is immobile while awake (awake immobile). Thus, actigraphy may have potential to better estimate true PS. We compared actigraphy to both Eastern Cooperative Oncology Group PS (ECOG PS) and patient-reported physical activity as predictors of survival in patients with stage IV non-small cell lung cancer (NSCLC). Methods: Participants (n = 41) were ambulatory patients with stage IV NSCLC receiving care at MGH. Participants wore a watch-sized accelerometer device (ACTIWATCH 2) for three consecutive 24-hour periods (72 hours) and completed a self-report questionnaire about physical activity, scored as METS (metabolic equivalents) per week. Patients’ oncologists rated their ECOG PS (0-5) at the end of the 72-hour actigraphy period. Relationships among ECOG PS, awake immobile, and METs per week were tested with Pearson correlations. A ROC curve for 6-month survival was used to determine a meaningful cut-off for awake immobile. Unadjusted Cox regression models tested associations with survival from assessment times. Results: Participants’ ECOG PS ratings were: 0 (22%), 1 (63%), 2 (12%), and 3 (2%). ECOG PS and awake immobile were correlated (r = .42, p < .01). METS per week was correlated only with ECOG PS (r = -.35, p = .03). At time of analysis, 15 patients had died with a minimum follow up of 9 months. Among all patients, survival was predicted by ECOG PS, HR = 3.77 (95% CI 1.70-8.35), p < .01; awake immobile as both as a continuous (percentage points) and categorical ( > 23%) variable, HR = 1.04 (95% CI 1.00-1.09), p = .05 and HR = 4.12 (95% CI 1.37-12.39), p = .01, respectively; but not METS per week. Among patients with good EGOC PS (0-1), only awake immobile ( > 23%) predicted survival, HR = 5.80 (95% CI 1.39-24.12), p = .02. Moreover, within the largest ECOG group (PS1), awake immobile ( > 23%) still predicted survival, HR = 5.53 (95% CI 1.18-25.94), p = .03. Conclusions: Actigraphy, an objective measure of patient activity, may have utility in determining patient PS.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4163-TPS4163
Author(s):  
Ann-Lii Cheng ◽  
Richard S. Finn ◽  
Masatoshi Kudo ◽  
Josep M. Llovet ◽  
Shukui Qin ◽  
...  

TPS4163 Background: Sorafenib is the accepted first-line systemic therapy for HCC, but no standard option is available for patients with tumor progression following sorafenib. An open-label phase II study suggested that REG, a multikinase inhibitor, had an acceptable safety profile and showed evidence of antitumor activity in patients with progressive HCC (Bolondi et al. Eur J Cancer 2011; 47 [Suppl 1]: abstract 6.576): disease control was achieved in 26/36 patients (72%) and median time to progression (TTP) was 4.3 months; median overall survival (OS) was 13.8 months. On the basis of these promising data, a phase III trial was designed. Methods: This randomized, double-blind, placebo (PBO)-controlled, multinational study (ClinicalTrials.gov identifier NCT01774344) will assess the efficacy and tolerability of REG vs PBO in patients with HCC that has progressed following sorafenib treatment (target n=530). Inclusion criteria include Barcelona Clinic Liver Cancer stage B or C disease, Child–Pugh A liver function, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Patients who discontinued sorafenib ≥8 weeks before study entry or who received other previous systemic therapy for HCC will be excluded. Patients will be randomized in a 2:1 ratio to receive REG 160 mg or matching PBO OD for weeks 1–3 of each 4-week cycle; all patients will also receive best supportive care. Treatment will continue until disease progression, death, intolerable toxicity, or patient/investigator decision to stop. Doses of study drug may be delayed or reduced to manage clinically significant drug-related toxicities. The primary endpoint is OS; secondary endpoints are TTP, progression-free survival, tumor response, and safety. Analysis will be according to randomized group, stratified by geographic region (Asia vs rest of world), ECOG PS (0 vs 1), alfa-fetoprotein level (<400 vs ≥400 ng/ml), extrahepatic disease (yes vs no), and macrovascular invasion (yes vs no). In addition, blood, plasma, and archival tissue will be assessed for pharmacokinetic and biomarker analyses, and health-related quality of life and health utility will be measured. Clinical trial information: NCT01774344.


Rheumatology ◽  
2021 ◽  
Author(s):  
Bonny Rockette-Wagner ◽  
Didem Saygin ◽  
Siamak Moghadam-Kia ◽  
Chester Oddis ◽  
Océane Landon-Cardinal ◽  
...  

Abstract Objective Idiopathic inflammatory myopathies (IIM) cause proximal muscle weakness, which affect activities of daily living. Wearable physical activity monitors (PAMs) objectively assess continuous activity with potential clinical usefulness in IIM assessment. We examined the psychometric characteristics for PAM outcomes in IIM. Methods Adult IIM patients were prospectively evaluated (baseline, 3 and 6-months) in an observational study. A waist-worn PAM (ActiGraph GT3X-BT) assessed average step counts/min, peak 1-min cadence, and vector magnitude/min. Validated myositis core set measures (CSM) including manual muscle testing (MMT), physician global disease activity (MD global), patient global disease activity (Pt global), extra-muscular disease activity (Ex-muscular global), HAQ-DI, muscle enzymes, and patient-reported physical function were evaluated. Test-retest reliability, construct validity, and responsiveness were determined for PAM measures and CSM using Pearson correlations and other appropriate analyses. Results 50 adult IIM patients enrolled [mean (SD) age, 53.6 (±14.6); 60% female, 94% Caucasian]. PAM measures showed strong test-retest reliability, moderate-to-strong correlations at baseline with MD global (r=-0.37- -0.48), Pt-global (r=-0.43- -0.61), HAQ-DI (r=-0.47- -0.59) and MMT (r = 0.37–0.52), and strong discriminant validity for categorical MMT and HAQ-DI. Longitudinal association with MD global (r=-0.38- -0.44), MMT (r = 0.50–0.57), HAQ-DI (r=-0.45- -0.55), and functional tests (r = 0.30–0.65) were moderate-to-strong. PAM measures were responsive to MMT improvement (≥10%) and moderate-to-major improvement on ACR/EULAR myositis response criteria. Peak 1-min cadence had the largest effect size and Standardized Response Means (SRMs). Conclusion PAM measures showed promising construct validity, reliability, and longitudinal responsiveness; especially peak 1-min cadence. PAMs provide valid outcome measures for future use in IIM clinical trials.


2017 ◽  
Vol 1 (S1) ◽  
pp. 40-41
Author(s):  
Stephen P. Wright ◽  
Kathryn Sandberg

OBJECTIVES/SPECIFIC AIMS: To analyze how consumer physical activity monitors are currently used in biomedical research. METHODS/STUDY POPULATION: Searches were conducted in Ovid Medline, PubMed Medline, clinicaltrials.gov, and NIH RePORTER using search terms including Fitbit, Jawbone, Apple watch, Garmin, Polar, Microsoft band, Misfit, Nike, Withings, and Xiaomi. Results were quantitated by category: condition/topic, intervention, enrollment status, study type and design, age, grant mechanism, and primary outcome. RESULTS/ANTICIPATED RESULTS: Fitbit is used >80%. There are 127 clinical studies using Fitbit devices listed in clinicaltrials.gov. In total, 48 have been completed while 79 are ongoing. Some studies have already published their findings; 40 papers cited in Ovid MEDLINE report use of a Fitbit device. NIH is now funding research that uses consumer physical activity monitors, and the NIH RePORTER shows the number of grants using Fitbit is rapidly increasing. DISCUSSION/SIGNIFICANCE OF IMPACT: The current state and potential growth of this technology is transforming biomedical research and is enabling us to ask new and more granular questions about activity and sleep in health and disease.


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