Mobile Sensor Technologies to Assess General Symptomology of People With Cancer

NCT04465214 | Completed

• 2 other identifiers: 17015817-C-0158
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors; Prostate Cancer; Lung Cancer; Colon Cancer; Neoplasms

Keywords

Apple iPhone; Apple Watch; Data Collection; acoustic neurotoxicity; cognitive status; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity

  4 months

Study Arms (1)

1/Cohort 1

Participants with a diagnosis of cancer who are under active treatment on a protocol at NIH

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of cancer who are under active treatment on a protocol at NIH

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• James L Gulley, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 10, 2020
• Study Start: November 23, 2020
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-12-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)