Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications

Self Cite

BackgroundBreast cancer represents the most common malignant disease in women worldwide. As currently systematic palliative treatment only has a limited effect on survival rates, the concept of health-related quality of life (HRQoL) is gaining more and more importance in the therapy setting of metastatic breast cancer. One of the major patient-reported outcomes (PROs) for measuring HRQoL in patients with breast cancer is provided by the European Organization for Research and Treatment of Cancer (EORTC). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. Facing the possibilities associated with evolving digitalization in medicine, validation of electronic versions of well-established PRO is essential in order to contribute to comprehensive and holistic oncological care and to ensure high quality in cancer research.ObjectiveThe aim of this study was to analyze the reliability of a tablet-based measuring application for EORTC QLQ-C30 in German language in patients with adjuvant and (curative) metastatic breast cancer.MethodsPaper- and tablet-based questionnaires were completed by a total of 106 female patients with adjuvant and metastatic breast cancer recruited as part of the e-PROCOM study. All patients were required to complete the electronic- (e-PRO) and paper-based versions of the HRQoL EORTC QLQ-C30 questionnaire. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability [Wilcoxon test] and test of internal consistency [Spearman rho and agreement rates for single items, Pearson correlation and Kendall tau for each scale]) were analyzed.ResultsHigh correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patient’s response behavior between paper- and electronic-based questionnaires. Regarding the test of parallel forms reliability, no significant differences were found in 27 of 30 single items and in 14 of 15 scales, whereas a statistically significant correlation in the test of consistency was found in all 30 single items and all 15 scales.ConclusionsThe evaluated e-PRO version of the EORTC QLQ-C30 is reliable for patients with both adjuvant and metastatic breast cancer, showing a high correlation in almost all questions (and in many scales). Thus, we conclude that the validated paper-based PRO assessment and the e-PRO tool are equally valid. However, the reliability should also be analyzed in other prospective trials to ensure that usability is reliable in all patient groups.Trial RegistrationClinicalTrials.gov NCT03132506; https://clinicaltrials.gov/ct2/show/NCT03132506 (Archived by WebCite at http://www.webcitation.org/6tRcgQuou).

Section: Introductionmentioning

confidence: 99%

Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial

Wallwiener¹,

Matthies²,

Simoes³

et al. 2017

Self Cite

“…Mobile devices such as mobile phones are becoming ubiquitous, with 77% of American adults reporting that they own a mobile phone [ 6 ]. A growing number of studies have examined the potential value of mobile or Web-based systems for patient reporting of symptoms [ 7 ]. Some of these systems include alerts to clinicians if patient-reported symptoms exceed a certain severity threshold [ 8 , 9 ] or tailored self-management support triggered by reported symptoms [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Estimation of Symptom Severity During Chemotherapy From Passively Sensed Data: Exploratory Study

Low¹,

Dey²,

Ferreira³

et al. 2017

BackgroundPhysical and psychological symptoms are common during chemotherapy in cancer patients, and real-time monitoring of these symptoms can improve patient outcomes. Sensors embedded in mobile phones and wearable activity trackers could be potentially useful in monitoring symptoms passively, with minimal patient burden.ObjectiveThe aim of this study was to explore whether passively sensed mobile phone and Fitbit data could be used to estimate daily symptom burden during chemotherapy.MethodsA total of 14 patients undergoing chemotherapy for gastrointestinal cancer participated in the 4-week study. Participants carried an Android phone and wore a Fitbit device for the duration of the study and also completed daily severity ratings of 12 common symptoms. Symptom severity ratings were summed to create a total symptom burden score for each day, and ratings were centered on individual patient means and categorized into low, average, and high symptom burden days. Day-level features were extracted from raw mobile phone sensor and Fitbit data and included features reflecting mobility and activity, sleep, phone usage (eg, duration of interaction with phone and apps), and communication (eg, number of incoming and outgoing calls and messages). We used a rotation random forests classifier with cross-validation and resampling with replacement to evaluate population and individual model performance and correlation-based feature subset selection to select nonredundant features with the best predictive ability.ResultsAcross 295 days of data with both symptom and sensor data, a number of mobile phone and Fitbit features were correlated with patient-reported symptom burden scores. We achieved an accuracy of 88.1% for our population model. The subset of features with the best accuracy included sedentary behavior as the most frequent activity, fewer minutes in light physical activity, less variable and average acceleration of the phone, and longer screen-on time and interactions with apps on the phone. Mobile phone features had better predictive ability than Fitbit features. Accuracy of individual models ranged from 78.1% to 100% (mean 88.4%), and subsets of relevant features varied across participants.ConclusionsPassive sensor data, including mobile phone accelerometer and usage and Fitbit-assessed activity and sleep, were related to daily symptom burden during chemotherapy. These findings highlight opportunities for long-term monitoring of cancer patients during chemotherapy with minimal patient burden as well as real-time adaptive interventions aimed at early management of worsening or severe symptoms.

“…Patients reporting their own outcomes have improved control of symptoms, medication adherence, and patient satisfaction. Furthermore, PROs provide distinct prognostic information, exceeding clinical measurements [ 54 - 56 ].…”

Section: Discussionmentioning

confidence: 99%

The Development of a Web-Based, Patient-Centered Intervention for Patients With Chronic Myeloid Leukemia (CMyLife): Design Thinking Development Approach

Ector¹,

Westerweel²,

Hermens³

et al. 2020

Background With the global rise in chronic health conditions, health care is transforming, and patient empowerment is being emphasized to improve treatment outcomes and reduce health care costs. Patient-centered innovations are needed. We focused on patients with chronic myeloid leukemia (CML), a chronic disease with a generally good long-term prognosis because of the advent of tyrosine kinase inhibitors. However, both medication adherence by patients and guideline adherence by physicians are suboptimal, unnecessarily jeopardizing treatment outcomes. Objective The aim of this study was to develop a patient-centered innovation for patients with CML using a design thinking methodology. Methods The 5 phases of design thinking (ie, empathize, define, ideate, prototype, and test) were completed, and each phase started with the patient. Stakeholders and end users were identified and interviewed, and observations in the care system were made. Using tools in human-centered design, problems were defined and various prototypes of solutions were generated. These were evaluated by patients and stakeholders and then further refined. Results The patients desired (1) insights into their own disease; (2) insights into the symptoms experienced, both in terms of knowledge and comprehension; and (3) improvements in the organization of care delivery. A web-based platform, CMyLife, was developed and pilot-tested. It has multiple features, all targeting parts of the bigger solution, including a website with reliable information and a forum, a guideline app, personal medical records with logs of symptoms and laboratory results (including a molecular marker and linked to the guideline app), tailored feedback based on the patients’ symptoms and/or results, screen-to-screen consulting, delivery of medication, and the collection of blood samples at home. Conclusions The multifeatured innovation, CMyLife, was developed in a multidisciplinary way and with active patient participation. The aim of developing CMyLife was to give patients the tools to monitor their results, interpret these results, and act on them. With this tool, they are provided with the know-how to consider their results in relation to their personal care process. Whether CMyLife achieves its goal and the evaluation of the added value will be the focus of future studies. CML could become the first malignancy for which patients are able to monitor and manage their disease by themselves.