Solid Tumors / Neoplasms / Prostate Cancer · Observational Study

Mobile Sensor Technologies to Assess General Symptomology of People With Cancer

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed observational feasibility study that enrolled 49 cancer patients to collect data using smartphones and wearable watches over 4 months, measuring symptoms via validated patient-reported outcome and performance-based instruments. No results are reported in this registry record, so the utility or validity of mobile sensor assessment in cancer populations remains undetermined.

What was studied

Observational. Neoplasms, Solid Tumors, Prostate Cancer, Lung Cancer, Colon Cancer; age from 18 Years; to 120 Years. Intervention: 1/Cohort 1. n = 49. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed observational registry study with no reported results; it describes methods for collecting sensor data from cancer patients to assess symptoms, but outcomes have not yet been published or registered.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests (assessed at 4 months)

DesignObservational

PopulationNeoplasms, Solid Tumors, Prostate Cancer, Lung Cancer, Colon Cancer; age from 18 Years; to 120 Years

Sample size49

Intervention1/Cohort 1

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size49

Follow-up duration4 months

Primary outcome measuresPRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, Normalized Reaction Time Tests

Study typeObservational

Caveats

No results, effect sizes, or outcome data are reported in this registry record.
Study is observational with no control arm, limiting causal inference.
No information on data quality, device compliance, or completion rates.
Generalizability limited to cancer patients enrolled in concurrent NIH treatment protocols.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with structured visits and standardized instruments; no control group.

Directness

moderate

Directly measures symptom outcomes using validated instruments and wearable sensors in cancer patients.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

No results reported; bias assessment cannot be performed.

Sample adequacy

limited

Small sample of 49 participants; adequacy depends on unpublished statistical analysis.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04465214). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 49 participants (ACTUAL). Conditions: Neoplasms, Solid Tumors, Prostate Cancer, Lung Cancer, Colon Cancer. Primary outcome measures: Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests , 4 months. 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. ...

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Solid TumorsNational Cancer Institute (NCI)NCT04465214NeoplasmsProstate Cancer