Cedars-Sinai trial uses Fitbit to better understand patients’ functional status

Prior research has shown patients with cancer who are more functional and active tend to achieve better outcomes on chemotherapy.

However, patient activity is self-reported, creating the potential for inaccuracies.

Arvind Shinde, MD, MBA, MPH, a faculty physician in the departments of supportive care medicine and hematology/oncology at Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, initiated a small trial using Fitbit activity trackers to assess patient activity outside of the clinical setting. The researchers intend to assess whether patients with cancer are functional enough to successfully undergo cancer treatment.

“What we are looking to do with our study is combine patient-reported outcomes and the data from the Fitbit trackers to see if it gives us more patient-centric assessment with less physician bias,” he said.

HemOnc Today spoke with Shinde about the launch of the program, the type of data he and his colleagues hope to obtain, and what he hopes a study like this ultimately will do for patients with cancer.

Question: How did the idea come about to use Fitbit as a means to track patients’ movement?

Answer: I practice as both a medical oncologist and palliative care specialist at Cedars-Sinai, working with patients and their families who are undergoing curative- or palliative-directed therapies. Practicing in this field has highlighted some of the challenges that exist for our patients. Two particular challenges I have been studying involve understanding which patients may or may not benefit from available chemotherapy choices, and which patients may be harmed by them. Second, how do we screen this population to detect the various forms of distress so we can better target supportive care resources to appropriate patients? Traditionally, we have used an assessment of performance status to determine whether a patient will tolerate chemotherapy. We know that patients who are more active tend to do better with their chemotherapy regimens. The problem is, the assessments used are old and susceptible to patient and physician bias. Further, they really do not capture how a patient is doing outside of the clinic. So, when the patient is not in clinic, we want to know how they are doing and what they are spending their time doing.

Additionally, when a patient comes to our clinic once every 3 or 4 weeks, we assess them for distress, checking both physical and psychosocial symptoms. However, this does not really reflect the free-range experience they have outside of the four walls of the clinic. Given the shortcomings of the current method, we thought an activity tracker potentially could allow for a more objective real-time assessment of a person’s performance status than ECOG performance status. Further, data from longitudinally collected patient-reported outcomes could add another layer of insight to our understanding of a patient’s functional status. We are looking to combine these patient-reported outcomes with activity data from the Fitbit trackers to see if they give us a more patient-centric assessment with less physician bias.

Q: What specific type of information do you hope to track and why?

A: We are not trying to assess or promote what is an appropriate amount of exercise for a patient with cancer. Instead, we are trying to assess how the patient is moving and how this relates to how functional they are. From the Fitbit, we hope to track how many steps a person is taking, how many stairs they are climbing, and their total active time and the intensity of the activity. We also are interested in their resting heart rate, as well as the quality and duration of their sleep. We are using patient-reported outcomes ― specifically NIH PROMIS tools ― and from this, we hope to assess a patient’s general functionality, their levels of fatigue, their pain interference and their emotional health. Looking at all of this information, we hope to understand how this relates to their general functional status. Secondarily, we are trying to see how the data from the tracker correlates with how much distress a person has. For example, is it possible that having an elevated heart rate, increased sleep latency or restlessness, or reduced mobility correlates with the presence of fatigue, pain or psychological distress?

Q: Will use of a Fitbit hold patients more accountable in terms of staying active?

A: This is an interesting question. We are not necessarily looking to keep them accountable, but there is this issue of the Hawthorne effect, in which people who know they are being observed tend to act in a certain way. Patients who are wearing a Fitbit say they feel like they are more active.

Q: Who will the participants be, and what methods will you use?

A: The trial just opened and we have enrolled a number of patients. At the current rate, I am expecting full patient accrual within the next few months. We are enrolling adults who have an advanced malignancy and who are being seen by an oncologist. Patients must have measurable disease, but they do not necessarily have to be undergoing cancer-directed treatment. We are asking our patients to wear the Fitbit Charge HR for 2 weeks. During this time, they are being asked to complete promise tools related to distress. Additionally, at the beginning of the study, patients will be assessed for frailty to evaluate the relationship between it and the data we are collecting from the activity tracker.

Q: If successful, do you plan to initiate a larger trial?

A: The short answer to this is yes. We have another study in which we are following patients with advanced pancreatic cancer who are receiving an intervention for cachexia. We are longitudinally assessing them and hypothesize that a better way of doing this would be to use the activity trackers combined with patient-reported outcomes. We plan to use the data from both this study and the Fitbit trial to inform the opening of a number of larger studies that will look at whether the information we can collect will predict chemotherapy toxicity and prognosis, help screen populations for distress, and help oncologists and patients together make more patient-centric decisions based upon how they are feeling and doing.

Q: Is this something other institutions could implement easily?

A: They can. We are using an EPIC-based electronic health record (HER) system, which is commonly used in many cancer centers and other health care institutions. The system we are testing ― utilizing activity trackers and patient-reported outcomes ― could be implemented with many EHRs. If this does show value, it can be easily implemented in other places with similar infrastructure.

Q: Is there anything else that you would like to add?

A: I would like to highlight the strong support of my two collaborators and their labs who are working on this project with me. Brennan Spiegel, MD, the director of health services research in academic affairs and clinical transformation, and Robert Figlin, MD, the division director for hematology and oncology and deputy director of Samuel Oschin Comprehensive Cancer Institute, have brought valuable insight and expertise in wearable technology, health services research and oncology to this multidisciplinary endeavor. – By Jennifer Southall

For more information:

Arvind Shinde, MD, MBA, MPH can be reached at Cedars-Sinai Medical Center, 8700 Beverly Blvd., Los Angeles, CA 90048; email: arvind.shinde@cshs.org.

Disclosure: Shinde reports no relevant financial disclosures.