RecruitingNCT05390827

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

3,692 participants

Start Date

May 19, 2022

Study Type

OBSERVATIONAL

Conditions

Solid Tumor

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria40

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
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)
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 Criteria6

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)