Smartwatches and devices, like the Apple Watch and iPhone, are able to collect and track an individual’s health data in ways never imagined just a decade ago.
The on-board sensors provide real-time and non-biased data on both symptoms, cognitive function, activity levels, and even insights into the patient’s mood throughout treatment for persons living with cancer (PLC).
Researchers have historically relied on clinically administered questionnaires and patient self-reports to assess a PLC’s level of function and capacity for self-care. These reports play a critical role in determining treatment and therapy options, viability, and performance.
However, those reports are intermittent, retroactive, and rely on oncology health care professionals’ judgment as well as a patient’s ability to recall events and describe their symptoms.
Additionally, until now, there has been no avenue to verify or confirm the accuracy of these reports.
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Can smartwatches and phones better collect and track cancer symptoms and treatment effects for people living with cancer?
The America Cancer Society estimates that this year there will be approximately 1.8 million new cancer cases diagnosed and over 600,000 cancer deaths in the United States from cancer.
For the past 50 years, clinicians have used written assessment tools to collect, track, and monitor a cancer patient’s disease and impacts.
While there have been clinical studies exploring the use and accuracy of electronic activity monitoring systems (EAM), these studies did not focus on cancer patients (oncology.)
The National Cancer Institute (NCI) believes there is a better way to record, track, and analyze the symptoms and impacts of disease on people living with cancer.
And at the heart of that is the belief that mobile devices, like the Apple Watch and iPhone, have the potential to dramatically transform the quality of clinical research and healthcare for cancer patients and survivors.
The National Cancer Insitute (NCI) is testing its theory in its new small pilot clinical study Mobile Sensor Technologies to Assess General Symptomology of People With Cancer.
NCI clinicians believe that smartwatches and smartphones can not only help assess a PLC’s symptoms, response to therapy, and quality of life but can also provide non-biased and continuous biometric data.
“Given the current limitations in the overall clinical evaluation of cancer patients, the use of remote sensor technologies can provide an objective, frequent, and near-real time stream of data in a machine-readable format that is free of human bias and can greatly enhance the ability of both clinicians and patients to manage the complexities of cancer care.”
There are also many benefits for the persons living with cancer when integrating a smartwatch and smartphone as part of their cancer care.
Since the Apple Watch automatically shares this with the patient, the hope is that this immediate feedback and information empowers PLCs to become active participants in their own care and their engagement in their activities of daily living.
How this NCI study works and what it looks at
This pilot study enrolls and analyzes the data from a total of 60 patients currently in treatment for their cancer at the NCI and who are 18 years or older with histologically or cytologically proven malignant tumors.
This includes these types of cancers: neoplasms, solid tumors, prostate cancer, lung cancer, and colon cancer.
This observational study started in July 2020.
Designed as a two-armed study
Following precedent and clinical trial norms, the NCI designed this study with two separate arms or groups that each follow the same guidelines and interventions.
Both Arm 1 and Arm 2 participants come to the clinic for a baseline visit.
Following that baseline visit, both Arm groups return to the clinic every 2-4 weeks based on the treatment protocol in which they are co-enrolled.
All Arm participants have a follow-up visit 4 months after the baseline visit–concluding the trial.
The major difference between the arms is Arm 1 collects data inside the clinic only, while Arm 2 collects data inside the clinic and collect data from the Apple Watch continuously (at home, work, and play) while enrolled.
Arm 1 description for the study Mobile Sensor Technologies to Assess General Symptomology of People With Cancer
Patients assigned to Arm 1 have all assessments done in the clinic.
NCI investigators and clinical staff use a specially programmed iPhone, Apple Watch, and NIH iPad in-house to collect data and assess patient fatigue, reaction time, and cognitive functioning.
This data is then compared with data collected from the current recommended protocols and questionnaires.
These include patient-reported outcome (PRO)- CTCAE fatigue and mood grading, ECOG/KPS, Neuro-QOL Ability to Participate in Social Roles and Activities short form, the Delis-Kaplan Executive Functioning System, and The NIH Toolbox.
Arm 2 description for the study Mobile Sensor Technologies to Assess General Symptomology of People With Cancer
Arm 2 of this study is a subset of enrolled patients who own iPhones personally and are able to monitor and record continuous health information outside of the clinic.
Each of these participants is either provided an Apple Watch throughout the study term or can opt to use their personally owned Apple Watch.
Participants wear the watch continuously while they are on study. Participants do not wear the watch at night to allow for charging. The study team estimates participants will wear the Apple Watch for 4 months.
Patients in Arm 2 complete the same group of assessments in the clinic as those in Arm 1. BUT the study adds the component of having all the additional continuous measurements of their activity recorded by an Apple Watch throughout their study participation.
Study Outcome Measures
All outcomes measures look at data from a 4-month timeframe.
Secondary Outcome Measures
- Correlation between biometric monitoring system measures of activity and function with KPS, ECOG performance status, and Neuro-QOL
- Association of patient-reported outcomes, including fatigue and ability to participate in social role and activities questions. And iPhone tests that assess mobility, fatigability and cognitive function
- Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity
This new study from NCI adds more validity to the efficacy of wearables when it comes to symptom tracking, continuous monitoring of activity, and remote monitoring of patients.
Apple is also using its ResearchKit and HealthKit with numerous hospitals and academic institutions to pursue additional use cases that go a long way in offering personalized paths to disease management and help improve quality of life.