Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Sensor Technologies to Assess General Symptomology of People With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465214
Recruitment Status : Enrolling by invitation
First Posted : July 10, 2020
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Neoplasms Solid Tumors Prostate Cancer Lung Cancer Colon Cancer

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer Patients
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
1/Cohort 1
Participants with a diagnosis of cancer who are under active treatment on a protocol at NIH



Primary Outcome Measures :
  1. Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests [ Time Frame: 4 months ]
    Percentage of patients successfully assessed for fatigue, reaction time, and cognitive status using an iPhone and Apple Watch.


Secondary Outcome Measures :
  1. Correlation between biometric monitoring system measures of activity and function with KPS, ECOG performance status and Neuro-QOL [ Time Frame: 4 months ]
  2. 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 [ Time Frame: 4 months ]
  3. Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of cancer who are under active treatment on a protocol at NIH
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465214


Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04465214    
Other Study ID Numbers: 170158
17-C-0158
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 18, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Apple iPhone
Apple Watch
Data Collection
acoustic neurotoxicity
cognitive status
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Neoplasms by Site
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases