Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial.

Symptoms are often underdetected during cancer treatment. To determine if symptom monitoring with electronic patient-reported outcomes (PROs) improves clinical outcomes, we conducted a cluster-randomized trial in which 52 oncology practices were assigned to PRO or usual care. At PRO practices, patients with metastatic cancer were invited to complete weekly symptom surveys.

Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework.

Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED).

Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care.

Although health care delivery is becoming increasingly digitized, driven by the pursuit of improved access, equity, efficiency, and effectiveness, progress does not appear to be equally distributed across therapeutic areas. Oncology is renowned for leading innovation in research and in care; digital pathology, digital radiology, real-world data, next-generation sequencing, patient-reported outcomes, and precision approaches driven by complex data and biomarkers are hallmarks of the field. However, remote patient monitoring, decentralized approaches to care and research, "hospital at home," and machine learning techniques have yet to be broadly deployed to improve cancer care.

Considerations for Conducting Bring Your Own "Device" (BYOD) Clinical Studies.

Background: Digital health technologies are attracting attention as novel tools for data collection in clinical research. They present alternative methods compared to in-clinic data collection, which often yields snapshots of the participants' physiology, behavior, and function that may be prone to biases and artifacts, e.g.

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial.

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.

Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.

Design, Setting, And Participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care.

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study.

Background: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials.

Objective: The aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials.

Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs.

Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative.

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators.

Determining Minimum Wear Time for Mobile Sensor Technology.

Part 1 in the DIA Study Endpoint Community Working Group on Mobile Sensor Technology (MST) series addresses considerations that may be useful when determining the minimum wear time associated with mobile sensor use to ensure reliable estimation of the clinical endpoint under consideration. What constitutes a minimum valid data set is a dilemma facing those using MSTs in clinical studies. If this alignment does not occur, the integrity of the data collected and conclusions drawn from these data may be in incorrect.

Performance Measures Based on How Adults With Cancer Feel and Function: Stakeholder Recommendations and Feasibility Testing in Six Cancer Centers.

Purpose: Patient-reported outcome measures (PROMs) that assess how patients feel and function have potential for evaluating quality of care. Stakeholder recommendations for PRO-based performance measures (PMs) were elicited, and feasibility testing was conducted at six cancer centers.

Methods: Interviews were conducted with 124 stakeholders to determine priority symptoms and risk adjustment variables for PRO-PMs and perceived acceptability.

Patient preferences for using mobile technologies in clinical trials.

The use of mobile technologies to collect participant data in clinical trials offers a number of scientific and logistical advantages. However, little is known about potential research participant preferences about how to incorporate mobile technologies into the design and conduct of a trial. Using a web-based survey which described hypothetical mobile clinical trial and traditional clinical trial scenarios, we explored patients' perceptions of and willingness to participate in mobile and traditional clinical trials, their preferred trial procedures related to the use of mobile technologies, and the preferred attributes of mobile technologies.

Personalized Medicine in the Oncology Clinic: Implementation and Outcomes of the Johns Hopkins Molecular Tumor Board.

Purpose: Tumor genomic profiling for personalized oncology therapy is being widely applied in clinical practice even as it is being evaluated more formally in clinical trials. Given the complexities of genomic data and its application to clinical use, molecular tumor boards with diverse expertise can provide guidance to oncologists and patients seeking to implement personalized genetically targeted therapy in practice.

Methods: A multidisciplinary molecular tumor board reviewed tumor molecular profiling reports from consecutive referrals at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins over a 3-year period.

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers.

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted.

American Society of Clinical Oncology executive summary of the clinical practice guideline update on the role of bone-modifying agents in metastatic breast cancer.

Purpose: To update the recommendations on the role of bone-modifying agents in the prevention and treatment of skeletal-related events (SREs) for patients with metastatic breast cancer with bone metastases.

Methods: A literature search using MEDLINE and the Cochrane Collaboration Library identified relevant studies published between January 2003 and November 2010. The primary outcomes of interest were SREs and time to SRE.

An accelerated pathway for targeted cancer therapies.

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.