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A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer Patients
Sponsor study identifier
Secondary identifiers
observational
49
1 country
1
Study Start
November 23, 2020
Actual (reported)Primary Completion
April 10, 2024
Actual (reported)Study Completion
April 10, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2020
Actual (reported)July 10, 2020
Actual (reported)November 23, 2020
Actual (reported)April 10, 2024
Actual (reported)April 10, 2024
Actual (reported)Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests
Percentage of patients successfully assessed for fatigue, reaction time, and cognitive status using an iPhone and Apple Watch.
4 months
Correlation between biometric monitoring system measures of activity and function with KPS, ECOG performance status and Neuro-QOL
4 months
Association of patient reported outcomes, including fatigue and ability to participate in social role and activities questions, with iPhone tests that assess mobility, fatigability and cognitive function
4 months
Participants with a diagnosis of cancer who are under active treatment on a protocol at NIH
Patients with a diagnosis of cancer who are under active treatment on a protocol at NIH
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
James L Gulley, M.D.
National Cancer Institute (NCI)
49 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2020
First Posted
July 10, 2020
Study Start
November 23, 2020
Actual (reported)Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity
4 months
Contact the study team to confirm eligibility.
Primary Completion
April 10, 2024
Actual (reported)Study Completion
April 10, 2024
Actual (reported)Last Updated
October 6, 2026
Record last verified: 2026-10-02
All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Source: ClinicalTrials.gov.
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