Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04465214 |
| Other study ID # |
170158 |
| Secondary ID |
17-C-0158 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 23, 2020 |
| Est. completion date |
April 1, 2025 |
Study information
| Verified date |
June 3, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Many digital devices, such as smartphones and activity monitors, have sensors to collect and
track health data. Researchers believe these devices may be able to transform the quality of
clinical research and healthcare. They believe they may be able to help assess the symptoms,
response to therapy, and quality of life of people with cancer.
Objective:
To collect data from people with cancer using an Apple iPhone alone or together with an Apple
Watch in order to assess their symptoms and activity levels.
Eligibility:
People ages 18 years and over who have cancer and receiving treatment for their cancer in
another NIH protocol
Design:
Participants will be screened with their medical records.
Participants will have a baseline visit. They will have visits every 2 4 weeks based on the
treatment protocol in which they are co-enrolled. Then they will have a follow-up visit 4
months after the baseline visit. Visits include:
Medical history
Physical exam
Karnofsky Performance Scale/Eastern Cooperative Oncology Group performance status to see how
their disease affects daily activities
The study team will use an iPhone to collect data. This includes a 6-minute walk test and
tests of hearing, reaction time, and cognitive status.
Questionnaires
If participants have an iPhone, an Apple Watch will be provided to them after training at the
baseline visit. Continuous measurement of their activity will be recorded by the watch
between 2 visits. They will wear the watch while they are on study. They will wear the watch
while it is not being charged. They should charge the watch at night time. They will have the
watch for 4 months.
Description:
Background:
- A growing number of mobile health solutions are enabling the tracking, diagnosis, and
management of various physiological processes and disease conditions, and many common
devices such as smartphones (e.g., iPhone) have integrated robust sensors to collect and
track this data.
- The two most commonly used tools in oncology include the Eastern Cooperative Oncology
Group Performance Status (ECOG PS) and Karnofsky Performance Status (KPS) scales that
were invented more than 50 years ago.
- Although standard performance status (PS) measurements are simple to implement in the
clinic, they are retrospective, subject to bias and limitations including intra- or
inter- observer variability, they are intermittent, providing a snapshot of the
participants status at the time of assessment, and they are largely subjective, relying
on physician judgement and participants ability to recall events and describe their
symptoms. The inability to retrospectively verify or confirm the accuracy of PS
assessment is another limitation.
- The benefits to participant care of knowing the accurate PS are extensive, including
making the right treatment decision based on the side effect profile, survival benefit
and eligibility on clinical trials.
- Biometric data can also play a role in empowering participants to become active
participants in their own care, by providing them with quantitative feedback on
activities of daily living and other functions.
- There are some studies exploring the accuracy of available electronic activity
monitoring (EAM) systems, but the available data on use of EAM systems in oncology
participants is limited.
- Continuous biometric data can provide actionable insights into fluctuations in not only
the activity level of cancer participants, but also their cognitive function and mood
throughout treatment cycles.
- Given the current limitations in the overall clinical evaluation of cancer participants,
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 participants to manage the
complexities of cancer care.
Objective:
This study will evaluate the feasibility of collecting data to assess fatigue, reaction time,
and cognitive functioning, in participants with cancer, using an Apple iPhone and Apple Watch
in the clinic setting and with or without additional activity monitoring in the home setting.
Eligibility:
- Inclusion criteria: Male or female subjects aged >= 18 years with a diagnosis of
malignant tumors who are under active treatment for cancer.
- Exclusion Criteria: Active central nervous system (CNS) metastases, known current
alcohol or drug abuse, any psychiatric condition that would prohibit the understanding
or rendering of informed consent.
Design:
This pilot study will be done in two arms (enrolled concurrently) with the goal of 60
evaluable participants across both arms (accrual ceiling will be set at 80).
Participants assigned to Arm 1 will have all assessments done in the clinic. A specially
programmed iPhone, Apple Watch, an NIH iPad, and investigator conducted assessments will be
used to collect data assessing participant fatigue, reaction time, and cognitive functioning.
These data will be compared with data collected from questionnaires including: 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 of this study will be a subset of enrolled participants who have a personally owned
iPhone. Participants in Arm 2 will complete the same battery of assessments in the clinic as
those in Arm 1, with additional continuous measurement of their activity recorded by an Apple
Watch at home, between clinic visits. Participants in Arm 2 will have the option of having
the apps designed for this study installed on their personally owned iPhones so they can
complete the app assessments at home. The Apple Watch will be given to these participants (or
they may use a personally owned Apple Watch) who will be trained by study staff on using the
device for continuous monitoring. Participants who agree to have the study apps installed on
their personally owned iPhone will be trained by study staff on the use of the apps.
