Protocol Details
A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer Patients
This study is NOT currently recruiting participants.
Summary
Number |
17-C-0158 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Adults who are or may become unable to consent;
Non-English Speaking;
Children |
Keywords |
Apple iPhone;
Apple Watch;
Data Collection;
acoustic neurotoxicity;
cognitive status;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Neoplasms;
Solid Tumors;
Prostate Cancer;
Lung Cancer;
Colon Cancer |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
-Signed written informed consent.
-Male or female subjects aged greater than or equal to 18 years.
-A cancer diagnosis.
-Participant should be under active treatment for cancer on a protocol at NIH.
EXCLUSION CRITERIA:
-Active central nervous system (CNS) metastases.
-Known current alcohol or drug abuse.
-Current marijuana use, including for medicinal purposes.
-Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
-Color blindness to any of the following colors: green, yellow, and/or red.
-Legal incapacity or limited legal capacity.
-Cancer survivors who are not actively receiving treatment.
-Non-English speaking subjects.
-Resting heart rate at screening, higher than 120 beats per minute.
-Systolic blood pressure at screening, higher than 180 mmHg.
-Diastolic blood pressure at screening, higher than 100 mmHg.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04465214