Memorial Sloan Kettering Cancer Center is working with Medidata to launch a small patient-generated health data trial of 40 patients with multiple myeloma, a blood cancer that accumulates in the bone marrow. Patients in the trial will track their activity and sleep with wearable devices and use an app to answer survey questions about quality of life measures like fatigue and appetite.
“Clinical oncology care is focusing on the individual, whether that means precision-based diagnostic testing a specific patient's tumor or cancer, or if that means how mobile wearable technology can assess an individual's quality of life as they are undergoing treatment,” Dr. Neha Korde, a hematologist at MSK who is leading the study, told MobiHealthNews in an email. “Because of the nature of the disease, myeloma patients are subject to bone pain and fractures. Pain is one of the most difficult symptoms to manage and assess. We believe that activity and sleep patterns will correlate with self-reported pain levels.”
Forty patients recently diagnosed with multiple myeloma at MSK will be split into two groups for the study. They will track their sleep, activity, and self-reported quality of life for four months, after wearing the tracker for a week to establish a baseline. Once the data is collected, MSK and Medidata, who are co-sponsoring the trial, hope to learn about the feasibility of patient-generated health data studies like this one.
“This is a first exercise and the hope is that we’d be able to take learnings from this exercise to the deployment of mobile health technologies either with this particular partner or with others,” Kara Dennis, managing director of mobile health at Medidata, told MobiHealthNews. “We want to make sure we can support the application of these tools with technology, so we’ve got mechanisms to gather and process and analyze all the data. We’re very focused on building tools for those purposes and we want to make sure this can be implemented in a way that patients can effectively use these tools and technologies and that investigative sites can also make use of these tools and technologies.”
Korde said that if the feasibility study shows the technology is easy to use for patients, as well as reliable and accurate then MSK is likely to expand to a larger trial. Dennis also said that if the trial goes well, Medidata may look to implement similar cancer trials with other partners.
“There is a broad interest from sponsors we’ve spoken with in quality of life in oncology as a way to evaluate one dimension of therapeutic impact,” she said. “So a number of companies, organizations are interested in understanding, while on therapy, what is the ability of patients to move, to leave their home, to be active, to be productive, to go to work? Those kinds of things along with sleep quality, ‘are subjects waking in the middle of the night’, duration, time to sleep onset, number of night awakenings, those kind of quality of life elements are interesting to many oncology sponsors we’ve spoken with.”