Remote Digital Physiologic Data Collection in Cancer: An MSK Registry Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3644 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-19

Study Completion Date

2027-07-31

Brief Summary

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The purpose of this study is to develop a secure method of collecting physiologic information from patients with cancer. The researchers will use this information to learn more about how physiologic data may relate to cancer diagnosis and response to treatment, and to identify factors that may lead to higher or lower risk of cancer.

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Detailed Description

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Project 1: HealthKit This prospective registry cohort study will aim to recruit a total of 3,000 patients and 500 adults without a history of cancer. The targeted patient cohorts / settings will aim to be : (1) pre-treatment / during treatment: patients with newly diagnosed early-stage, low-grade, or locally advanced solid tumors that are either pre- or during treatment, (2) post-treatment: patients with primary solid tumor diagnose is that are post-treatment, (3) advanced disease setting: patients diagnosed with metastatic or high-grade disease, (4) patients enrolled onto investigational trials in the early drug development (EDD) Service, (5) patients admitted to Urgent Care Center (UCC), and (6) patients completing a Survivorship Patient Self-Assessment as part of follow-up in an MSK Survivorship clinic. This study will accrue patients receiving care at any MSK site. Adults without a history of cancer will be recruited as a comparison group. The targeted adults without a history of cancer cohorts will aim to be (n=250/cohort): (7) adults without a history of cancer \<50 years of age, and (8) adults without a history of cancer aged greater than or equal to 50 years.

Project 2: DigIT-Ex This prospective registry cohort study will aim to recruit a total of 120 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, which will be (n=48): (1) patients scheduled to undergo bone marrow transplantation, (2) patients newly diagnosed with acute myeloid leukemia (AML), (3) patients scheduled to undergo surgery for localized prostate cancer (4) patients scheduled to undergo surgery for lung cancer, (5) patients scheduled to undergo total neoadjuvant therapy for advanced rectal cancer, (6) patients scheduled to undergo antiandrogen therapy for advanced prostate cancer, and (7) patients scheduled to undergo chemotherapy for metastatic pancreatic cancer. The targeted adults without a history of cancer cohorts will be (n=12/cohort): (8) individuals without a history of cancer aged less than 50 years, and (9) individuals without a history of cancer aged greater than or equal to 50 years.

Conditions

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Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Project 1: HealthKit

* Individuals who meet at least one of the following criteria:

* Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor
* Historical diagnosis of primary invasive solid tumor
* Diagnosis of metastatic (stage IV) or high-grade (III-IV) disease
* Enrolled onto an investigational trial in the EDD Service
* Seen in the MSK UCC from 2021 and onwards
* Completion of Survivorship Patient Self-Assessment
* Adult without a history of cancer \<50 years of age
* Adult without a history of cancer ≥ 50 years of age
* ≥18 years old
* Own an Apple iPhone with valid iOS operating software
* Have a registered MSK MyChart account and be willing to download the MSK Remote Monitoring (RM) application onto their personal iPhone
* Self-reported "very well" comprehension of written and verbal English language
* Willing and able to provide informed consent and HIPAA authorization for the release of personal health information

Project 2: DigIT-Ex

Individuals who meet one of the following criteria:

* Patients at MSK who are:
* Scheduled to undergo any type of BMT (Cohort 1)
* Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)
* Scheduled to undergo any surgery for prostate cancer (Cohort 3)
* Scheduled to undergo any lung cancer surgery (Cohort 4)
* Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)
* Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):
* High risk/very high localized, locally advanced,
* Biochemically recurrent prostate cancer
* Treatment naïve, low-volume metastatic prostate cancer
* Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)
* Individuals without cancer \<50 years of age (Cohort 8)
* Individuals without cancer ≥50 years of age (Cohort 9)

* 18 to 90 years old at the time of consent
* Willing and able to download the Withings Health Mate app onto their personal mobile device
* Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent
* Willing to provide informed consent

Exclusion Criteria

Project 1: HealthKit

* Unable or unwilling to successfully export and /or share physiological data

Project 2: DigIT-Ex

* Unable or unwilling to appropriately use digital platforms or devices

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes