Recruiting NCT05390827

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

— Observational Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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 168 patients and 24 adults without a history of cancer. The targeted adult patient cohorts / settings will be (n=12/cohort), excluding cohort 6, and 10 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. and (10) patients scheduled to undergo surgery for metastatic bone disease.

For Cohort 10 (patients scheduled to undergo surgery for metastatic bone disease), an expanded DigIT-Ex sub-study will be conducted. This sub-study will enroll up to 40 patients with metastatic cancer to bone of the lower extremity who are undergoing non-emergent orthopaedic stabilization surgery. Participants will be monitored longitudinally for functional activity using wearable activity monitors for a minimum of 5 days prior to surgery and for up to 4 months following surger 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.

Primary outcome measures

establish a mechanism within the institution to prospectively collect / extract digital remote physiological data among patients with cancer [Time frame: 1 year]

Eligibility criteria

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 or Android with valid operating software
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)
Receiving outpatient care at Memorial Sloan Kettering Cancer Center (MSK)(Cohort 10)
Diagnosed with metastatic cancer to bone (Cohort 10)
Scheduled for non-emergent orthopaedic surgery to stabilize lower-extremity bone metastases (Cohort 10)
Able to undergo at least 5 consecutive days of preoperative monitoring prior to surgery (Cohort 10)
Have had a CT scan including the L3 vertebral level within 3 months before surgery (used to assess skeletal muscle mass and sarcopenia) (Cohort 10)
Have a ≥50% predicted likelihood of 6-month postoperative survival, as estimated by the PATHFx clinical decision-support tool (Cohort 10
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 for Cohorts 1-9, and 4 months following consent for Cohort 10.
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
Require a wheelchair for ambulation (Cohort 10)
Are undergoing stabilization surgery for a primary bone tumor (rather than metastatic disease) (Cohort 10)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Cohort

Study locations

United States · 1 center

Memorial Sloan Kettering Cancer Center — New York

Identifiers

NCT: NCT05390827 · 20-330

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗