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Protocol Details

A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0158

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240C
10 CENTER DR
BETHESDA MD 20892
(301) 480-7164
gulleyj@mail.nih.gov

Katherine O. Lee-Wisdom, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N240
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3525
katherine.lee-wisdom@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04465214

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